| Trial ID: | L5564 |
| Source ID: | NCT01779375
|
| Associated Drug: |
Metformin
|
| Title: |
RISE Pediatric Medication Study
|
| Acronym: |
RISE Peds
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT01779375/results
|
| Conditions: |
Prediabetes|Type 2 Diabetes
|
| Interventions: |
DRUG: Metformin|DRUG: Glargine
|
| Outcome Measures: |
Primary: ß-cell Response Measured by Hyperglycemic Clamp, Clamp measures of ß-cell response, co-primary outcomes, 3-months after medication washout (Month 15)|M/I, Clamp measure of insulin sensitivity, 3-months after a medication washout | Secondary: ACPRg, First phase response, 3-months after a medication washout|ß-cell Function Measured by Hyperglycemic Clamp Techniques at M12, Participants had 12-months of active therapy. Secondary results at the end of active intervention., End of active intervention (Month 12).|Clamp Measure of Insulin Sensitivity, Participants had 12-months of active therapy. Secondary results at the end of active intervention., End of active intervention (Month 12) | Other: OGTT Measures of ß-cell Function and Glucose Tolerance, Measures derived the OGTT at the end of the 12 month active intervention period, and following a 3-month and 9-month washout., After 12 months of active treatment, and 3 and 9 months of washout
|
| Sponsor/Collaborators: |
Sponsor: RISE Study Group | Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
|
| Gender: |
ALL
|
| Age: |
CHILD, ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
91
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2013-06-16
|
| Completion Date: |
2018-04
|
| Results First Posted: |
2018-10-09
|
| Last Update Posted: |
2023-04-14
|
| Locations: |
Childrens Hospital Colorado, Denver, Colorado, 80045, United States|Yale School of Medicine Pediatric Obesity and Type 2 Diabetes Clinic, New Haven, Connecticut, 06511, United States|Indiana University, Indianapolis, Indiana, 46202, United States|Children's Hospital of Pittsburgh of UPMC, Pittsburgh, Pennsylvania, 15224, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT01779375
|
