RISE Pediatric Medication Study
Overview[ - collapse ][ - ]
Purpose | The RISE Pediatric Medication Study is a 2-arm, 4-center, clinical trial of children with prediabetes and early type 2 diabetes to address the hypothesis that aggressive glucose lowering will lead to recovery of beta-cell function that will be sustained after withdrawal of treatment. Pediatric participants (ages 10-19) will be randomized to one of the following treatment regimens: (1) metformin alone or (2) early intensive treatment with basal insulin glargine followed by metformin. The primary clinical question RISE will address is: Are improvements in ß-cell function following 12 months of active treatment maintained for 3 months following the withdrawal of therapy? Secondary outcomes will assess durability of glucose tolerance following withdrawal of therapy, and whether biomarkers obtained in the fasting state predict parameters of ß-cell function, insulin sensitivity and glucose tolerance and the response to an intervention. |
---|---|
Condition | Prediabetes Type 2 Diabetes |
Intervention | Drug: Metformin Drug: Glargine |
Phase | Phase 3 |
Sponsor | RISE Study Group |
Responsible Party | RISE Study Group |
ClinicalTrials.gov Identifier | NCT01779375 |
First Received | January 28, 2013 |
Last Updated | December 19, 2013 |
Last verified | December 2013 |
Tracking Information[ + expand ][ + ]
First Received Date | January 28, 2013 |
---|---|
Last Updated Date | December 19, 2013 |
Start Date | April 2013 |
Estimated Primary Completion Date | August 2017 |
Current Primary Outcome Measures | ß-cell function measured by hyperglycemic clamp techniques [Time Frame: 3-months after a medication washout] [Designated as safety issue: No]Participants will have 12-months of active therapy and 3-months of washout after which the primary outcome will be assessed. |
Current Secondary Outcome Measures | Hyperglycemic clamp and oral glucose tolerance test (OGTT) measures of ß-cell Function and Glucose Tolerance [Time Frame: 3-months after a medication washout] [Designated as safety issue: No]Measures derived from the hyperglycemic clamp that are not specified as primary outcomes and measures derived from the OGTT. |
Descriptive Information[ + expand ][ + ]
Brief Title | RISE Pediatric Medication Study |
---|---|
Official Title | Restoring Insulin Secretion Pediatric Medication Study |
Brief Summary | The RISE Pediatric Medication Study is a 2-arm, 4-center, clinical trial of children with prediabetes and early type 2 diabetes to address the hypothesis that aggressive glucose lowering will lead to recovery of beta-cell function that will be sustained after withdrawal of treatment. Pediatric participants (ages 10-19) will be randomized to one of the following treatment regimens: (1) metformin alone or (2) early intensive treatment with basal insulin glargine followed by metformin. The primary clinical question RISE will address is: Are improvements in ß-cell function following 12 months of active treatment maintained for 3 months following the withdrawal of therapy? Secondary outcomes will assess durability of glucose tolerance following withdrawal of therapy, and whether biomarkers obtained in the fasting state predict parameters of ß-cell function, insulin sensitivity and glucose tolerance and the response to an intervention. |
Detailed Description | Not Provided |
Study Type | Interventional |
Study Phase | Phase 3 |
Study Design | Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment |
Condition |
|
Intervention | Drug: Metformin Other Names: GlucophageDrug: Glargine Other Names: Insulin glargine, Lantus |
Study Arm (s) |
|
Recruitment Information[ + expand ][ + ]
Recruitment Status | Recruiting |
---|---|
Estimated Enrollment | 90 |
Estimated Completion Date | August 2017 |
Estimated Primary Completion Date | August 2017 |
Eligibility Criteria | Inclusion Criteria: 1. Fasting plasma glucose ≥90 mg/dl plus 2-hour glucose ≥140 mg/dl on 75 gm OGTT plus laboratory-based HbA1c ≥5.8 and ≤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 <3 months and ≤7.0% if on metformin for 3-6 months. 2. Age 10-19 years 3. Pubertal development Tanner stage >1 as defined by breast stage >1 in girls, and testes >3 cc's in boys. 4. Body mass index (BMI) ≥85th percentile but ≤50 kg/m2 5. Self-reported diabetes <6 months in duration 6. Treatment with metformin for <6 months preceding screening 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 medications that affect glucose metabolism, or has an underlying condition that is likely to require such medications 4. Treatment with insulin for >1 week preceding screening 5. Active infections 6. Renal disease (serum creatinine >1.2 mg/dl) or serum potassium abnormality (<3.4 or >5.5 mmol/l) 7. Anemia (hemoglobin <11 g/dl in girls, <12 g/dl in boys) or known coagulopathy 8. Cardiovascular disease, including uncontrolled hypertension defined as average systolic or diastolic blood pressure > 99 percentile for age or >135/90, despite adequately prescribed antihypertensive medications. Participants must be able to safely tolerate administration of intravenous fluids required during clamp studies. 9. History of conditions that may be precipitated or exacerbated by a study drug: 1. Serum alanine transaminase (ALT) more than 3 times the upper limit of normal 2. Excessive alcohol intake 3. Sub-optimally treated thyroid disease 10. Conditions or behaviors likely to affect the conduct of the RISE Study 1. Participant and/or parents unable or unwilling to give informed consent 2. Participant and/or parents unable to adequately communicate with clinic staff 3. Another household member is a participant or staff member in RISE 4. Current, recent or anticipated participation in another intervention research project that would interfere with any of the interventions/outcomes in RISE 5. Weight loss of ≥5% of body weight in the past 3 months for any reason other than post-partum weight loss. Participants taking weight loss drugs or using preparations taken for intended weight loss are excluded. 6. Likely to move away from participating clinics in next 2 years 7. Current (or anticipated) pregnancy and lactation. 8. A pregnancy that was completed less than 6 months prior to screening. 9. Breast feeding within 6 months prior to screening. 10. Women of childbearing potential who are unwilling to use adequate contraception 11. Major psychiatric disorder that, in the opinion of clinic staff, would impede the conduct of RISE 11. Additional conditions may serve as criteria for exclusion at the discretion of the local site. |
Gender | Both |
Ages | 10 Years |
Accepts Healthy Volunteers | Accepts Healthy Volunteers |
Contacts | Not Provided |
Location Countries | United States |
Administrative Information[ + expand ][ + ]
NCT Number | NCT01779375 |
---|---|
Other Study ID Numbers | RISE Pediatric |
Has Data Monitoring Committee | Yes |
Information Provided By | RISE Study Group |
Study Sponsor | RISE Study Group |
Collaborators | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
Investigators | Not Provided |
Verification Date | December 2013 |
Locations[ + expand ][ + ]
Childrens Hospital Colorado | Denver, Colorado, United States, 80045 Contact: Rose Moorehead | 720-777-2855 | Kristen.Nadeau@childrenscolorado.orgPrincipal Investigator: Kristen Nadeau, MD Recruiting |
---|---|
Yale School of Medicine Pediatric Obesity and Type 2 Diabetes Clinic | New Haven, Connecticut, United States, 06511 Contact: Bridget Pierpont, M.A. | 203-785-2942 | bridget.pierpont@yale.eduPrincipal Investigator: Sonia Caprio, MD Recruiting |
Indiana University | Indianapolis, Indiana, United States, 46202 Contact: Tammy Garrett, RN | 317-274-7679 | tjgarret@iupui.eduPrincipal Investigator: Kieren Mather, MD Recruiting |
Children's Hospital of Pittsburgh of UPMC | Pittsburgh, Pennsylvania, United States, 15224 Contact: Kathy Brown | 412-692-5846 | kathleen.brown@chp.eduPrincipal Investigator: Silva Arslanian, MD Recruiting |