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Tolerance & Responsiveness Improvement for Metformin (TRIM)

NCT03670043 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2021-09-10

No results posted yet for this study

Summary

The overall goal is to explore the hypothesis that prebiotic fiber Psyllium will ameliorate diarrhea in African American men (AAM) with Type2 Diabetes Mellitus (T2D).

Conditions

  • Type2 Diabetes Mellitus

Interventions

DRUG

Psyllium powder

To evaluate whether Psyllium will alleviate diarrhea

DRUG

Metformin Extended Release Oral Tablet

Metformin Extended Release Oral Tablet is standard of care for diarrhea in patients taking metformin

Sponsors & Collaborators

  • West Side Institute for Science and Education

    lead OTHER

Principal Investigators

  • Barengolts · Jesse Brown VA Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
70 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-19
Primary Completion
2020-10-15
Completion
2021-08-15
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT03670043 on ClinicalTrials.gov