| Trial ID: | L4933 |
| Source ID: | NCT02045290
|
| Associated Drug: |
Metformin
|
| Title: |
Insulin Clamp Ancillary Study for Assessment of Insulin Resistance
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 1 Diabetes
|
| Interventions: |
DRUG: Metformin|DRUG: Placebo
|
| Outcome Measures: |
Primary: Change in insulin resistance (IR) from baseline to 13 weeks, Hyperinsulinemic euglycemic clamp to assess metformin's impact on muscle IR via glucose infusion rate (GIR)., 0-13 weeks | Secondary: Change in Hepatic IR from baseline to 13 weeks, Graded hyperinsulinemic euglycemic clamp with glucose and glycerol isotopes to assess metformin's impact on: • Hepatic IR, 0-13 weeks|Change in Adipose IR from baseline to 13 weeks, Graded hyperinsulinemic euglycemic clamp with glucose and glycerol isotopes to assess metformin's impact on: • Adipose IR, 0-13 weeks
|
| Sponsor/Collaborators: |
Sponsor: Jaeb Center for Health Research | Collaborators: Juvenile Diabetes Research Foundation
|
| Gender: |
ALL
|
| Age: |
CHILD, ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
37
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2014-01
|
| Completion Date: |
2016-02-15
|
| Results First Posted: |
|
| Last Update Posted: |
2017-03-14
|
| Locations: |
Jaeb Center for Health Research, Tampa, Florida, 33647, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT02045290
|
