Tolerance & Responsiveness Improvement for Metformin (TRIM)

  • STATUS
    Recruiting
  • End date
    Mar 24, 2023
  • participants needed
    60
  • sponsor
    West Side Institute for Science and Education
Updated on 24 January 2021

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).

Details
Condition Type2 Diabetes Mellitus
Treatment Metformin Extended Release Oral Tablet, Psyllium powder
Clinical Study IdentifierNCT03670043
SponsorWest Side Institute for Science and Education
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 20 yrs and 70 yrs?
Are you male?
Do you have Type2 Diabetes Mellitus?
Do you have any of these conditions: Do you have Type2 Diabetes Mellitus??
Male (M)
African American (AA) race
Age 20-70 years
BMI 28-59 kg/m2
T2D
A1c 6.5 - 8.9%
eGFR =/> 30
Drug-nave or use Glipizide or newly started on Metformin (within 2 weeks)

Exclusion Criteria

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
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