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NCT01756833	12.2.6	Data Coordinating Center Interface with Clinical Coordinating Center	12.2.6 Data Coordinating Center Interface with Clinical Coordinating Center Conference calls, facsimile transmission, e-mail and courier will be used to maintain frequent and regular communications between the Clinical Coordinating Center and the Data Coordinating Center. The investigators will discuss study activities...	[]
NCT01756833	12.2.7	Data Coordinating Center Role in Training of Study Personnel	12.2.7 Data Coordinating Center Role in Training of Study Personnel Prior to the start of recruitment and in conjunction with the training session planned by the Clinical Coordinating Center, DCC staff will organize training for Clinical Site staff to review enrollment of patients using the Interactive Web-based Random...	[]
NCT01756833	12.3	STUDY TIME LINE	12.3 STUDY TIME LINE The study will last five years and be broken into the following phases. 1) Planning and Organization Phase 1 (months 1-4): Finalize the Manual of Operations and data collection instruments. Communicate with the Clinical Site directors at each study site. Obtain IRB approval at clinical sites with a...	[ "CHAPTER 13 – POLICY MATTERS" ]
NCT01756833	13.1	PUBLICATION POLICY	13.1 PUBLICATION POLICY	[]
NCT01756833	13.1.1	General Statement of Editorial Policy	13.1.1 General Statement of Editorial Policy It is anticipated that the Doxycycline Treatment of Abdominal Aortic Aneurysm Clinical Trial (N-TA3CT) will generate considerable new data relative to patients with aortic aneurysms. The Steering Committee fosters and guides development of scientific reports originating from...	[]
NCT01756833	13.1.2	Types of Research	13.1.2 Types of Research Research and the resulting presentations and publications are grouped into the following categories: - 1. Design paper(s) and reports on methods. - 2. Mainline findings. - 3. Data bank studies. - 4. Ancillary studies. - 5. Independent studies. Distinctions among these types of studies are given...	[]
NCT01756833	13.1.3	Authorship	13.1.3 Authorship The first publication(s) pertaining to the fundamental goals of N-TA3CT involving patients enrolled in the study will list the members of the writing team as the authors with "the N-TA3CT Research Group" as the last author. An appendix listing the Principal Investigator and Co-Investigators will be in...	[]
NCT01756833	13.1.4	Purpose of Procedural Guidelines	13.1.4 Purpose of Procedural Guidelines The procedures adopted by the investigators for use of study data are intended to protect the interests of all participants in the study, to assure that study data conform to the requirements of study design and are accurately presented, that authorship is appropriately acknowled...	[]
NCT01756833	13.2	DESIGN AND METHODS REPORTS, MAINLINE FINDINGS, DATA BANK, ANCILLARY, AND INDEPENDENT STUDIES	13.2 DESIGN AND METHODS REPORTS, MAINLINE FINDINGS, DATA BANK, ANCILLARY, AND INDEPENDENT STUDIES	[]
NCT01756833	13.2.1	Design Papers and Reports on Methodology	13.2.1 Design Papers and Reports on Methodology Manuscripts concerning the overall design, protocol, procedures, or organizational structure of the study that do not involve mainline findings or data collected on study patients may be published prior to the end of the study. Such preliminary publications will be develo...	[]
NCT01756833	13.2.2	Reports of Mainline Findings	13.2.2 Reports of Mainline Findings A report on mainline findings is one addressing the fundamental goals of N-TA3CT or that involves protocol data -- such as changes in aneurysm size or MMP-9 levels over time in study patients -- which cannot be released prior to the end of the study. These studies will summarize the ...	[]
NCT01756833	13.2.3	Data Bank Studies	13.2.3 Data Bank Studies A data bank study uses data or specimens (including banked specimens) which are routinely collected on patients who are recruited and/or enrolled in the N-TA3CT. Analysis of these data are used to answer specific scientific questions. Data used in this research are not directly related to the f...	[]
NCT01756833	13.2.4	Ancillary Studies	13.2.4 Ancillary Studies An ancillary study uses supplementary data that are collected on patients who are recruited and/or enrolled in N-TA3CT, over and above the data collection required by the protocol. Such studies are restricted to consideration of a specific test technique or involve only the supplemental data co...	[]
NCT01756833	13.2.5	Independent Studies	13.2.5 Independent Studies Independent studies of concern to N-TA3CT are studies conducted in potential patients who are not enrolled in the study, but data are collected at a Clinical Site. These data are not transmitted to the N-TA3CT Clinical Coordinating Center or Data Coordinating Center. It is understood that eac...	[]
NCT01756833	13.3	GUIDELINES FOR PREPARATION OF PROPOSALS FOR DATA BANK AND ANCILLARY STUDIES	13.3 GUIDELINES FOR PREPARATION OF PROPOSALS FOR DATA BANK AND ANCILLARY STUDIES	[]
NCT01756833	13.3.1	Data Bank and Ancillary Studies	13.3.1 Data Bank and Ancillary Studies Each proposal for an ancillary or data bank study should contain a brief description of the objectives, methods, analysis plans, significance of the study, and proposed collaborators. Full details should be given concerning any procedures to be carried out, such as cytokine evalua...	[]
NCT01756833	13.4	PROCEDURES FOR INITIATION AND APPROVAL OF STUDIES	13.4 PROCEDURES FOR INITIATION AND APPROVAL OF STUDIES	[]
NCT01756833	13.4.1	Reports on Mainline Findings	13.4.1 Reports on Mainline Findings Reports on mainline findings from N-TA3CT generally involve the collaboration of many investigators. Proposals for these reports are introduced and developed by any N-TA 3CT Investigator or staff member with the approval of the Clinical Site director. These reports are reviewed and a...	[]
NCT01756833	13.4.1.1	Submission of Proposals	13.4.1.1 Submission of Proposals Two copies of each proposal should be submitted to the Data Coordinating Center for inventory and transmission to the Management Committee. The Director of the DCC notifies the Investigator when the project is approved, disapproved or whether additional information is needed before a de...	[]
NCT01756833	13.4.1.2	Preparation of Mainline Reports	13.4.1.2 Preparation of Mainline Reports After approval of a proposed topic for a mainline report, members are elected or invited to serve on an ad hoc Writing Subcommittee and a Chairperson is chosen. These investigators work with the CCC and DCC staff to conduct the data analysis needed to investigate the question at...	[]
NCT01756833	13.4.1.3	Review and Approval of Abstracts and Manuscripts Prior to Presentation and Publication	13.4.1.3 Review and Approval of Abstracts and Manuscripts Prior to Presentation and Publication Every study manuscript considered suitable for publication is submitted by the Chairperson of the Writing Subcommittee to the DCC for distribution to the Publications Committee. The Chair of the Publications and Ancillary St...	[]
NCT01756833	13.4.2	Data Bank Studies	13.4.2 Data Bank Studies	[]
NCT01756833	13.4.2.1	Submission of Proposals	13.4.2.1 Submission of Proposals Data bank studies must be approved by the Management Committee and ratified by the Steering Committee. Before beginning a data bank project, a proposal initiated by one or more of the Investigators and/or their associates is submitted to the DCC for inventory and distribution to the Man...	[]
NCT01756833	13.4.2.2	Conduct of Data Bank Studies	13.4.2.2 Conduct of Data Bank Studies After approval is given by the Steering Committee, the Investigators (on the data bank project) work with the CCC and DCC staff to conduct the data analysis.	[]
NCT01756833	13.4.2.3	Priorities for Work	13.4.2.3 Priorities for Work Because of the routine work load at the CCC and DCC, it is necessary to establish priorities for data processing and analysis. Therefore, the DCC staff conduct analyses on data bank studies in the order in which they have been approved or, as necessary, seek guidance from the Management Com...	[]
NCT01756833	13.4.2.4	Authorship	13.4.2.4 Authorship After a data bank study proposal is approved by the Steering Committee, its research and development are the responsibility of the identified investigators on the project. Authorship decisions on data bank studies take into account the unique cooperative effort that has produced the results. For cli...	[]
NCT01756833	13.4.2.5	Review and Approval of Abstracts and Manuscripts Prior to Presentation or Publication	13.4.2.5 Review and Approval of Abstracts and Manuscripts Prior to Presentation or Publication The Publications and Ancillary Studies Committee reviews all data bank study abstracts and manuscripts prior to submission for presentation and publication. Recommendations are forwarded to the Management Committee for review...	[]
NCT01756833	13.4.3	Ancillary Studies	13.4.3 Ancillary Studies	[]
NCT01756833	13.4.3.1	Submission of Proposals	13.4.3.1 Submission of Proposals Ancillary study proposals are reviewed by the Management Committee and are ratified by the Steering Committee to ensure that the proposed study does not conflict with the primary goals of N-TA3CT. Two copies of each proposal are submitted to the Data Coordinating Center for inventory an...	[]
NCT01756833	13.4.4	Independent Studies	13.4.4 Independent Studies Results of independent studies which are approved as acceptable by the Management Committee may be published or presented at the discretion of investigators initiating the independent study.	[]
NCT01756833	13.5	RELEASE OF N-TA3CT DATA OR SPECIMENS TO NON- N-TA3CT INVESTIGATORS	13.5 RELEASE OF N-TA3CT DATA OR SPECIMENS TO NON- N-TA3CT INVESTIGATORS Requests for study results, study data, or banked specimens may be submitted by investigators who are not participating in N-TA3CT during the course of this investigation. These requests will arise primarily from colleagues and researchers who are ...	[]
NCT01756833	13.6	CONFLICT OF INTEREST POLICY	13.6 CONFLICT OF INTEREST POLICY	[]
NCT01756833	13.6.1	General Principles	13.6.1 General Principles The N-TA3CT investigators have agreed to a policy on conflict of interest which has few specific restrictions, but a broad indication for disclosure of potential conflicts of interest. The N-TA3CT investigators wish to endorse the spirit and content of the 21st Bethesda Conference: Ethics in C...	[]
NCT01756833	13.6.2	Individuals to be Governed by These Guidelines	13.6.2 Individuals to be Governed by These Guidelines Members of the N-TA3CT Study Group who will be governed by these guidelines include the Study Chairman, the director at each Clinical Site, key personnel in the Clinical Coordinating Center, Biomarkers Core Laboratory, Imaging Core Laboratory, and Data Coordinating ...	[]
NCT01756833	13.6.3	Time Period of the Policy	13.6.3 Time Period of the Policy The guidelines set forth in this policy commence at the start of patient recruitment and will terminate at the time of initial public presentation or publication of the principal results. Investigators not privy to end point data who discontinue participation in the study during recruit...	[]
NCT01756833	13.6.4	Financial Guidelines	13.6.4 Financial Guidelines 1. The investigators agree not to own, buy or sell stock or stock options during the aforementioned time period in any of the pharmaceutical companies or related medical equipment companies with products used in this study. In addition, the investigators agree not to have retainer-type consu...	[]
NCT01756833	13.6.5	Reporting of Financial Disclosures and Other Activities	13.6.5 Reporting of Financial Disclosures and Other Activities The investigators agree to update their financial disclosures and related activities as described above on an annual basis and submit these data to the Clinical Coordinating Center for storage. The Clinical Coordinating Center staff maintain the confidentia...	[]
NCT01756833	13.6.6	Review of Policy Statement	13.6.6 Review of Policy Statement The investigators agree to review these guidelines on an annual basis and take any additional steps to insure that the scientific integrity of the study remains intact.	[]
NCT01756833	13.6.7	Relationship to Institutional Policies on Conflict of Interest	13.6.7 Relationship to Institutional Policies on Conflict of Interest Since existing policies on conflict of interest vary among participating institutions, in addition to the above policy, it is expected that investigators comply with the policies on conflict of interest which exist within their individual participati...	[]
NCT01756833	13.7	HUMAN SUBJECTS TRAINING	13.7 HUMAN SUBJECTS TRAINING All N-TA3CT investigators and staff who have any contact with N-TA3CT patients, with health care providers treating N-TA3CT patients, with individual patients' N-TA3CT data or specimens must complete approved training in human subjects research and provide documentation of current training ...	[ "EXHIBIT 13-1 – Conflict of Interest Statement for N-TA3CT Investigators CONFIDENTIAL", "References", "Appendix – N-TA3CT Procedures and Treatments" ]
NCT01779375	1	Executive Summary	1 Executive Summary Type 2 diabetes in youth is associated with the onset of multiple diabetes-related complications in the teenage and early adult years, such as microalbuminuria, retinopathy, hypertension, cardiac hypertrophy, dyslipidemia and nonalcoholic fatty liver disease. In adults with type 2 diabetes, these co...	[]
NCT01779375	1.1	Specific Aims and Objectives	1.1 Specific Aims and Objectives The primary objective of the RISE Pediatric Medication Study is to compare, in a preliminary proof-of-principle trial, the efficacy of two treatment strategies on measures of ß-cell function after 3-months of post-treatment washout that will follow 12 months of active treatment. Partici...	[]
NCT01779375	1.2	Overall Design and Study Interventions	1.2 Overall Design and Study Interventions The RISE Pediatric Medication Study is a preliminary proof-of-principle, two-arm open-label study in which volunteers with prediabetes or recent onset type 2 diabetes (HbA1c levels ≤8.0% if treatment naïve, ≤7.5% if on metformin for <3 months and ≤7.0% if on metformin for 3-6 ...	[]
NCT01779375	2	Background and Significance	2 Background and Significance	[]
NCT01779375	2.1	Prediabetes and Type 2 Diabetes: Epidemiology, Natural History and Pathogenesis	2.1 Prediabetes and Type 2 Diabetes: Epidemiology, Natural History and Pathogenesis The increasing prevalence of obesity in youth and adults has been associated with a relentless rise in the prevalence of type 2 diabetes and prediabetes (impaired glucose tolerance [IGT] and/or impaired fasting glucose [IFG]). In the Un...	[]
NCT01779375	2.2	Obstructive Sleep Apnea (OSA) and Diabetes Risk	2.2 Obstructive Sleep Apnea (OSA) and Diabetes Risk The alarming increase in overweight and obesity plays a pivotal role in the rise in diabetes prevalence. The obesity epidemic has in turn resulted in an increased prevalence of OSA, a treatable sleep disorder involving shallow and fragmented sleep as well as intermitt...	[]
NCT01779375	2.3	Results of Type 2 Diabetes Prevention Studies	2.3 Results of Type 2 Diabetes Prevention Studies A number of studies have established the ability to slow the progression from prediabetes to diabetes in adults. Overall, the greatest success has been achieved with the three thiazolidinediones (TZDs) which in TRIPOD (Troglitazone In the Prevention of Diabetes), DPP (D...	[]
NCT01779375	2.4	Long Term Intervention Studies in Patients with Early Type 2 Diabetes	2.4 Long Term Intervention Studies in Patients with Early Type 2 Diabetes Registration studies have examined the glucose-lowering effects of new medications for treating type 2 diabetes in adults. These studies frequently have been relatively short in duration (6-12 months) and follow up has typically been in the form ...	[]
NCT01779375	2.5	Metformin	2.5 Metformin Metformin is a glucose lowering medication of the biguanide class that has been used in the management of type 2 diabetes for over 50 years. It reduces the excess hepatic glucose production that characterizes type 2 diabetes without increasing insulin secretion. In fact, in the DPP it was documented that ...	[]
NCT01779375	2.6	Insulin Glargine	2.6 Insulin Glargine Insulin glargine is a recombinant human insulin analogue that in most subjects is administered once daily, as it forms subcutaneous microprecipitates from which small amounts of this analogue are released, resulting in a relatively constant profile over 24 hours. It has been used since 2000 to trea...	[]
NCT01779375	2.7	Approaches to Measuring ß-cell Function, -cell Function, Insulin Sensitivity and Glucose Tolerance	2.7 Approaches to Measuring ß-cell Function, -cell Function, Insulin Sensitivity and Glucose Tolerance Glucose homeostasis is physiologically modulated under fasting and prandial conditions by a number of regulatory factors, most prominently insulin and glucagon. Measurements made under fasting conditions are frequentl...	[]
NCT01779375	2.7.1	Intravenous Tests of ß- and -cell Function and Insulin Sensitivity	2.7.1 Intravenous Tests of ß- and -cell Function and Insulin Sensitivity Glucose tolerance is dependent on ß-cell function and insulin sensitivity, and both of these can be quantified using the hyperglycemic clamp [\[84\]](#page-67-7). The role of -cell function in determining glucose tolerance is less well defined. Th...	[]
NCT01779375	2.7.2	Oral Tests of ß- and -cell Function and Insulin Sensitivity	2.7.2 Oral Tests of ß- and -cell Function and Insulin Sensitivity The OGTT provides measures of islet function and has been used in large clinical trials for this purpose. The early insulin response (insulinogenic index) is an important determinant of glucose tolerance [\[34\]](#page-63-4). This response, when used in ...	[]
NCT01779375	2.8	Biomarkers of ß-cell Function, -cell Function, Insulin Sensitivity and Glucose Tolerance	2.8 Biomarkers of ß-cell Function, -cell Function, Insulin Sensitivity and Glucose Tolerance It is often the case that biologic phenomena of interest are both difficult and costly to measure directly. This can be true of physiologic states such as ß-cell function, but it is also true for timedependent changes such as r...	[]
NCT01779375	2.8.1	Putative Diabetes Biomarkers	2.8.1 Putative Diabetes Biomarkers The detailed measures of β-cell function that we will be making provide an opportunity to identify biomarkers that can predict deterioration of β-cell function and/or response to interventions that can mitigate such deterioration. The identification of such biomarkers is an important ...	[]
NCT01779375	3	STUDY DESIGN	3 STUDY DESIGN	[]
NCT01779375	3.1	Overview and Rationale	3.1 Overview and Rationale This document is specific for the RISE Pediatric Medication Protocol that three pediatric centers, with a contribution from the adult center at Indiana University, are performing together in youth with prediabetes or recent onset type 2 diabetes. This preliminary proof-ofprinciple study is a ...	[]
NCT01779375	3.2	Primary Outcomes	3.2 Primary Outcomes The primary objective of the RISE Study is to evaluate the effects of randomized treatment on ß-cell function, measured by hyperglycemic clamp techniques. Given that insulin and C-peptide are both used in quantifying ß-cell function, each of them will be measured in certain or all tests in part to ...	[]
NCT01779375	3.3	Secondary Outcomes	3.3 Secondary Outcomes There are a number of pre-specified secondary outcomes. These include measures derived from the hyperglycemic clamp that are not specified as primary outcomes; measures derived from the OGTT; analyses related to treatment effect at the end of the 12 month active intervention period compared to pr...	[]
NCT01779375	3.3.1	ß-cell Function and Glucose Tolerance	3.3.1 ß-cell Function and Glucose Tolerance - (i) Hyperglycemic clamp-derived ß-cell measures: - a. First phase insulin response (incremental insulin area from 0-10 minutes after initial glucose bolus) - b. First phase C-peptide response (incremental C-peptide area from 0-10 minutes after initial glucose bolus) - c. Di...	[ "(ii) OGTT-derived ß-cell measures:", "(iii) Fasting measures:" ]
NCT01779375	3.3.2	-cell Function	3.3.2 -cell Function A. Hyperglycemic clamp-derived measures: - a. Glucagon suppression in response to sustained hyperglycemia during the clamp (the decrement in glucagon concentration from baseline to nadir value at 100-120 minutes) - b. Acute glucagon response to arginine (the incremental increase in glucagon concen...	[ "A. Hyperglycemic clamp-derived measures:" ]
NCT01779375	3.3.3	Insulin Sensitivity	3.3.3 Insulin Sensitivity - (i) Hyperglycemic clamp-derived measures: glucose disposal rate at steady state (100-120 minutes) divided by ambient insulin concentrations - (ii) OGTT-derived measures: - a. Matsuda index - b. Model-derived insulin sensitivity - (iii) Fasting measures: - a. 1/fasting insulin, - b. HOMA-S (u...	[]
NCT01779375	3.3.4	Blood and Urine Biomarkers	3.3.4 Blood and Urine Biomarkers - (i) Glycemic control: HbA1c (baseline predictor, and as a time-dependent treatment outcome) - (ii) Adipokines/inflammatory markers: adiponectin; others contingent on funding (see list above in Section 2.8.1) - (iii) Non-esterified fatty acids - (iv) Renal/vascular: urinary albumin/cre...	[]
NCT01779375	3.3.5	Physical Measures	3.3.5 Physical Measures (i) Physical measures: blood pressure, body weight, body mass index, waist and hip circumference.	[]
NCT01779375	3.4	Treatments	3.4 Treatments	[]
NCT01779375	3.4.1	Three-week Placebo Run-in Phase	3.4.1 Three-week Placebo Run-in Phase Prior to randomization, eligible volunteers will participate in a 3-week run-in period. They will be instructed by study staff in proper injection technique and will receive three weeks placebo tablets. Participants already on metformin will be provided metformin at their entering ...	[]
NCT01779375	3.4.2	Twelve-month Active Treatment Phase	3.4.2 Twelve-month Active Treatment Phase Participants will be randomized to one of the two interventions. Participants will be seen every three months throughout the study and will be given three months of medication at a time during the active treatment phase. Study staff will monitor compliance by auditing returned ...	[]
NCT01779375	3.4.3	Metformin	3.4.3 Metformin Metformin use is the same in all treatment groups that use it. To minimize non-compliance due to gastrointestinal side effects, patients who are not already on metformin will be titrated over a maximum of eight weeks from a starting dose of 500 mg once daily to a maximum dose of 1000 mg bid. Participant...	[]
NCT01779375	3.4.4	Insulin Glargine Followed by Metformin	3.4.4 Insulin Glargine Followed by Metformin Insulin will be titrated over a period of one month based on daily self-blood glucose monitoring to achieve a fasting blood glucose of 80-90 mg/dl without hypoglycemia, and then continued with dose adjustments to maintain the fasting glucose in this range. Insulin glargine h...	[]
NCT01779375	3.4.5	Medication Wash-out and Post-treatment Follow Up	3.4.5 Medication Wash-out and Post-treatment Follow Up Following the completion of the intensive re-assessments (hyperglycemic clamp and OGTT) after 12 months of the intervention, study medications will be stopped and the participants will continue to be followed off medications, for a minimum of 3 months and up to 9 m...	[]
NCT01779375	3.4.6	Rescue	3.4.6 Rescue The approach to rescuing a participant with severe hyperglycemia is described in Section 7.4.	[]
NCT01779375	3.5	Inclusion Criteria	3.5 Inclusion Criteria - 1. Fasting plasma glucose ≥90 mg/dl plus 2-hour glucose ≥140 mg/dl on 75 gm OGTT plus laboratory-based HbA1c ≤8.0% if treatment naïve. There is no upper limit for the 2 hour glucose on OGTT. In those taking metformin laboratory-based HbA1c must be ≤7.5% if on metformin for 1 as defined by breas...	[]
NCT01779375	3.6	Exclusion criteria	3.6 Exclusion criteria - 1. Underlying disease likely to limit life span and/or increase risk of intervention or an underlying condition that is likely to limit ability to participate in outcomes assessment - 2. An underlying disease that affects glucose metabolism other than type 2 diabetes mellitus - 3. Taking medica...	[]
NCT01779375	3.7	Randomization	3.7 Randomization Randomization is stratified by clinical center and by prediabetes vs. diabetes status to ensure balance among the treatment groups with respect to anticipated differences in the participant populations. For each clinical center, the Coordinating Center (CoC) will generate two randomization schemes usi...	[]
NCT01779375	3.8	Masking	3.8 Masking During the run-in period, participants who are drug-naive will take metformin placebo. All participants will be taught how to perform injections to assess compliance with possible study medications. Placebo injections will not be used during the active treatment phase – i.e., the treatment assignment will n...	[]
NCT01779375	4	RECRUITMENT	4 RECRUITMENT	[]
NCT01779375	4.1	Recruitment	4.1 Recruitment The primary source of participants for the RISE Study is the active patient population of the study sites and their usual referral sources. Participants will be recruited over a three year period. Recruitment techniques include notices placed on bulletin boards at the medical centers, newspaper and radi...	[]
NCT01779375	4.2	Description/Justification of the Target Study Population	4.2 Description/Justification of the Target Study Population Preliminary screening will be done to enrich the yield of individuals who have prediabetes or type 2 diabetes. These individuals will be invited for initial field testing using clinical, HbA1c and/or OGTT criteria. Youth who are highly predisposed to develop ...	[]
NCT01779375	4.3	Informed Consent	4.3 Informed Consent Written informed consent will be obtained prior to initiation of any study-related activities. The informed consent process will be performed in a quiet setting prior to the initiation of any study procedures. The subject and his/her parents will be provided adequate time to read and understand the...	[]
NCT01779375	4.4	Staged Screening and Randomization	4.4 Staged Screening and Randomization Screening for enrollment in RISE will be conducted in a stepwise manner involving completion of a screening visit and a 3-week run-in period at the end of which baseline measurements, including the OGTT and hyperglycemic clamp, will be performed. Screening proceeds from least inva...	[]
NCT01779375	5	PATIENT MANAGEMENT	5 PATIENT MANAGEMENT	[]
NCT01779375	5.1	Description of RISE Research Facility Treatment(s)	5.1 Description of RISE Research Facility Treatment(s) Study treatment interventions are described in detail above (Section 3.4). Glucose management (including study medications) will be provided free of charge to RISE participants. In accordance with standards of care, HbA1c will be monitored every 3 months. Procedure...	[]
NCT01779375	5.2	Drug Distribution	5.2 Drug Distribution Study medications will be distributed to individual study centers. Individual centers will organize and maintain inventory, in cooperation with their investigational or research pharmacy. Sites will ensure that sufficient medication is always on hand to allow medication distribution for the next 3...	[]
NCT01779375	5.3	Adherence Measures	5.3 Adherence Measures Adherence will be documented, monitored, and addressed as part of participant care and management and to monitor whether procedures are being implemented and followed equivalently across all sites. Adherence refers to all study procedures – not only taking the prescribed amount of study drug, but...	[]
NCT01779375	5.3.1	Placebo Run-in	5.3.1 Placebo Run-in Metformin/placebo compliance will be assessed by pill counting as a percentage of the expected pills that were taken. Active metformin will be provided to subjects already on metformin at the dose they were currently taking, and compliance assessed by pill counting as a percentage of the provided e...	[]
NCT01779375	5.3.2	Insulin	5.3.2 Insulin Insulin will not be blinded in RISE. Insulin use will be prescribed to assigned participants only for the first 3 months of their participation. The projected volume consumed cannot be generalized, but will need to be calculated for each participant based on their recorded dosing titration and their final...	[]
NCT01779375	5.4	Retention	5.4 Retention Retention refers to efforts to prevent participant dropout or withdrawal from the study. It is critically important to successfully engage and retain participation over the course of the trial. For purposes of sample size estimation, we have predicted withdrawal rates of 10% during the 15-months of primar...	[]
NCT01779375	6	DATA COLLECTION	6 DATA COLLECTION	[]
NCT01779375	6.1	Main Study Procedures	6.1 Main Study Procedures The timing of major study procedures during the different phases of the study is illustrated in Figure 1. Outcomes using hyperglycemic clamp procedures will be obtained at baseline, at the end of 12 months of treatment, and after a 3-month washout period (i.e., 15 months post randomization). A...	[]
NCT01779375	6.1.1	Fasting Blood and Urine Samples	6.1.1 Fasting Blood and Urine Samples HbA1c will be measured and fasting blood and urine samples will be collected at each 3 monthly study visit. Aliquots of fasting blood and urine will be stored for subsequent measurement of biomarkers. A blood sample for DNA will be collected at randomization for subsequent genetic ...	[]
NCT01779375	6.1.2	Oral Glucose Tolerance Test (OGTT)	6.1.2 Oral Glucose Tolerance Test (OGTT) Participants will come to the clinical research testing facility in the morning following a 10-12 hour overnight fast. They will drink 75 grams of an oral glucose solution (centrally provided from a single manufacturer) over ≤5 minutes. Blood samples will be obtained at -10, -5,...	[]
NCT01779375	6.1.3	Hyperglycemic Clamp	6.1.3 Hyperglycemic Clamp Hyperglycemic clamps (goal steady state glucose levels of 200 mg/dl and >450 mg/dl) will be performed at baseline, 12 months post randomization while on active treatment, and 15 months post randomization (i.e., after 3 months of washout). Participants will return to the testing facility to und...	[]
NCT01779375	6.2	Eligibility Screening Measurements	6.2 Eligibility Screening Measurements Screening and run-in procedures are listed in Table 1. Prescreening (initial contact): Prescreening for potential eligibility can be done using a single random capillary (finger stick) blood sample for measurement of HbA1C with a POC instrument or a lab HbA1c as a guide to help de...	[]
NCT01779375	6.3	Baseline and Post-Randomization Measures	6.3 Baseline and Post-Randomization Measures Measurements to evaluate safety, adherence, and outcomes are summarized in Table 2. The outcomes, derived from hyperglycemic clamp procedures, will be measured at baseline, 12 months (end of treatment), and 15 months post randomization (end of washout). OGTT outcomes measure...	[]
NCT01779375	6.3.1	Physical Measures	6.3.1 Physical Measures Height will be measured with a stadiometer. Weight will be measured with a calibrated electronic scale. Waist and hip circumferences will be measured at the mid-point between the iliac crest and the lowest rib (waist), and at the top of the femur (hip) with the participant standing upright.	[]
NCT01779375	6.3.2	Sleep Assessments	6.3.2 Sleep Assessments During screening, participants will complete the Cleveland Adolescent Sleepiness Questionnaire and the Sleep Disturbance Scale for Children for analysis of self-reported sleep-related measures as potential predictors of response to treatment.	[]
NCT01779375	6.3.3	Safety Measures	6.3.3 Safety Measures The study will provide blood glucose monitors and strips for use during the study. Participants with diabetes will be instructed to monitor and record fasting blood glucose daily, in the morning, and as otherwise instructed for safety monitoring. Routine local laboratory studies consisting of a he...	[]
NCT01779375	6.3.4	Participant Protocol Adherence	6.3.4 Participant Protocol Adherence Pill counts will be performed at each visit from run-in to the end of the treatment period. Similarly, glargine pen residual volume will be determined. Participants will be asked to bring all medications to all visits. For participants with diabetes and for those on glargine, self m...	[]
NCT01779375	6.4	Visit Windows	6.4 Visit Windows Participants will be encouraged to complete visits within a 1-2 week window before or after the scheduled study visit. All participants will have a visit calendar generated at the time of randomization to assist in keeping visits scheduled as required. The specific actions recommended when a visit win...	[]
NCT01779375	7	SAFETY / HUMAN SUBJECTS PROTECTION	7 SAFETY / HUMAN SUBJECTS PROTECTION This trial will be conducted in compliance with the protocol and all applicable regulatory requirements. All participating clinical sites must have a Federal-wide Assurance with the Office for Human Research Protections. All sites will follow HIPAA regulations. Prior to study initia...	[]

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