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Metformin Gastrointestinal Intolerance: Measurement of Mitochondrial Complex I

NCT03445702 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2020-10-28

No results posted yet for this 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.

Conditions

  • Diabetes Mellitus, Type 2
  • Metformin Adverse Reaction

Interventions

DRUG

Metformin

Metformin 1000mg once

DRUG

Placebo

Sugar pill manufactured to mimic metformin 1000mg

Sponsors & Collaborators

  • Washington University School of Medicine

    collaborator OTHER

  • St. Louis University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
40 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-10-15
Primary Completion
2020-10-27
Completion
2020-10-27
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03445702 on ClinicalTrials.gov