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NCT03445702 · ClinicalTrials.gov registry record · Early Phase 1
Metformin Gastrointestinal Intolerance: Measurement of Mitochondrial Complex I
A Early Phase 1 study of Diabetes Mellitus, Type 2 and Metformin Adverse Reaction, sponsored by St. Louis University.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 15
- Enrollment target
- 1
- Study location
NCT03445702: Completed Early Phase 1 study of Diabetes Mellitus, Type 2 and Metformin Adverse Reaction, sponsored by St. Louis University.
NCT03445702 is a Early Phase 1 study of Diabetes Mellitus, Type 2 and Metformin Adverse Reaction that has completed, run by St. Louis University. The registered enrollment target is 15 participants, below the 4,485-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03445702, a Early Phase 1 study of Diabetes Mellitus, Type 2 and Metformin Adverse Reaction, has completed, sponsored by St. Louis University.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 15 participants
- Enrollment target
- 1
- Study location
Study Summary
Metformin is associated with a high degree of gastrointestinal intolerance, which limits the effective use of the medication. It is proposed to be an inhibitor of liver mitochondrial glycerophosphate dehydrogenase which results in partial blockade of mitochondrial complex 1 and inhibition of metabolism of lactate to pyruvate. There is also evidence that it is accumulated in gastrointestinal cells, and that there are certain genotypes associated with inclusion or lack of exclusion of the metformin from these cells. To validate this hypothesis investigators propose to give metformin after a standard meal test to see if there is the accumulation of lactic acid in those with gastrointestinal intolerance to metformin, compared to those without intolerance, and to determine if these elevations of lactic acid and GI symptoms are associated with genetic predispositions. Aims: 1. To determine if the GI intolerance to metformin is associated with post meal elevations of lactic acid. a. The test will measure the inhibition of mitochondrial complex 1 levels of lactate to pyruvate compared with non- intolerant subjects. 2. To determine if individuals with gastrointestinal symptoms and elevated lactate/pyruvate ratios have genetic variation in the organic cation transporters.
Primary Outcome
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).
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Metformin
Study Locations (1)
Missouri
- Saint Louis University - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2018-10-15 |
| Est. Completion | 2020-10-27 |
| Phase | Early Phase 1 |
What the finished NCT03445702 record still lists
NCT03445702 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 4,485-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (100% lower).
The record links to 2 conditions, with Diabetes Mellitus, Type 2 appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT03445702 reports a single indexed study location in Missouri.
Frequently Asked Questions
What is clinical trial NCT03445702 about?
NCT03445702 is a clinical study titled "Metformin Gastrointestinal Intolerance: Measurement of Mitochondrial Complex I". Metformin is associated with a high degree of gastrointestinal intolerance, which limits the effective use of the medication. It is proposed to be an inhibitor of liver mitochondrial glycerophosphate dehydrogenase which results in partial blockade of mitochondrial complex 1 and inhibition of metabol...
What is the current status of trial NCT03445702?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 15 participants. The study started on 2018-10-15. Estimated completion is 2020-10-27.
What conditions does trial NCT03445702 study?
This clinical trial studies the following conditions: Diabetes Mellitus, Type 2, Metformin Adverse Reaction.
What interventions are being tested in trial NCT03445702?
The interventions under investigation include: Placebo (DRUG), Metformin (DRUG).
Who is sponsoring clinical trial NCT03445702?
This trial is sponsored by St. Louis University, which has 107 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03445702 being conducted?
This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03445702's enrollment target sits among peer trials
15 336th of 348 higher than 11 of 348 other Diabetes Mellitus, Type 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetes Mellitus, Type 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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