| Trial ID: | L6441 |
| Source ID: | NCT04264897
|
| Associated Drug: |
Metformin
|
| Title: |
Antecedent Metabolic Health and Metformin Aging Study
|
| Acronym: |
ANTHEM
|
| Status: |
UNKNOWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Aging|Insulin Sensitivity|Chronic Disease|Mitochondria|Insulin Resistance
|
| Interventions: |
DRUG: Metformin|DRUG: Placebo oral tablet
|
| Outcome Measures: |
Primary: Mean change in insulin sensitivity measure, Change in insulin sensitivity as determined by a hyperinsulinemic-euglycemic clamp, Change from baseline to 12 weeks|Mean change in mitochondrial function of the electron transport system measured by complex I activity, Mitochondrial function of the electron transport system, Change from baseline to 12 weeks | Secondary: Mean change in daily average glucose measure, 5-day continuous glucose monitoring, Change from baseline to 12 weeks|Mean change in blood-based biomarker measures of aging, HbA1c, glucose, and insulin, Change from baseline to 12 weeks
|
| Sponsor/Collaborators: |
Sponsor: Oklahoma Medical Research Foundation | Collaborators: National Institute on Aging (NIA)|University of Oklahoma|University of Wisconsin, Madison
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
148
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
|
| Start Date: |
2020-07-29
|
| Completion Date: |
2024-04-30
|
| Results First Posted: |
|
| Last Update Posted: |
2023-03-23
|
| Locations: |
University of Oklahoma Health Sciences Center, Oklahoma Shared Clinical and Translational Resources, Oklahoma City, Oklahoma, 73104, United States|University of Wisconsin-Madison, Madison, Wisconsin, 53705, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT04264897
|
