| Trial ID: | L4691 |
| Source ID: | NCT03445702
|
| Associated Drug: |
Metformin
|
| Title: |
Metformin Gastrointestinal Intolerance: Measurement of Mitochondrial Complex I
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 2|Metformin Adverse Reaction
|
| Interventions: |
DRUG: Metformin|DRUG: Placebo
|
| Outcome Measures: |
Primary: Lactate to pyruvate ratio, Meal tolerance test. Absolute levels and ratios of L/P will be compared pre and post metformin and between group by analysis of variance for repeated measures where the covariance is group (tolerant or intolerant) and drug (metformin vs placebo)., 2 weeks | Secondary: Genomic testing, The subjects will have genomic testing for variations in cellular transporters, 2 weeks
|
| Sponsor/Collaborators: |
Sponsor: St. Louis University | Collaborators: Washington University School of Medicine
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
EARLY_PHASE1
|
| Enrollment: |
15
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: SCREENING
|
| Start Date: |
2018-10-15
|
| Completion Date: |
2020-10-27
|
| Results First Posted: |
|
| Last Update Posted: |
2020-10-28
|
| Locations: |
Saint Louis University, Saint Louis, Missouri, 63110, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT03445702
|
