Tolerance & Responsiveness Improvement for Metformin (TRIM)

Completed · Phase 4

Conditions studied: Type2 Diabetes Mellitus

In brief

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).

Key facts

Study ID

NCT03670043

Run by

West Side Institute for Science and Education

People needed

29

Starts

2019-03-19

Expected to finish

2021-08-15

Last updated by the study team

2021-09-10

Who can join

Age: 20 and older, up to 70. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Male (M)
• African American (AA) race
• Age 20-70 years
• BMI 28-59 kg/m2
• T2D
• A1c 6.5 - 8.9%
• eGFR =/> 30
• Drug-naïve or use Glipizide or newly started on Metformin (within 2 weeks).

You may not qualify if…

• Chronic kidney disease stage 3b, 4 and 5 (eGFR < 30)
• Insulin use
• Oral steroids use (inhalers and creams are allowed)
• Antibiotic use within the last month
• Artificial heart valves
• Hospitalization for chronic condition within 6 months prior to the study
• History, manifestations or medications of significant metabolic, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, urological, neurological, psychiatric/ psychological disorders, or social circumstances which in the opinion of the investigator would be expected to interfere with the study or increase risk to the subject.
• Use of other antidiabetic drugs (except glipizide and metformin).
• Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma.
• Additional Exclusion criteria for subjects who previously used Metformin:
• Previous severe allergic reaction to metformin hydrochloride, such as angioedema.
• Previous Metformin intolerance causing significant diarrhea or GI-upset. Would not exclude participants who had history of mild diarrhea with metformin use.
• Previous side effects that the subject feels were related to Metformin and the subject is not interested to re-try metformin.

Where it is running

• Jesse Brown VA Medical Center — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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