Tolerance & Responsiveness Improvement for Metformin (TRIM)

West Side Institute for Science and Education

Status and phase: Completed; Phase 4

Conditions: Type2 Diabetes Mellitus

Treatments: Drug: Metformin Extended Release Oral Tablet; Drug: Psyllium powder

Study type: Interventional

Funder types: Other

Identifiers

NCT03670043

1005965

Details and patient eligibility

About

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).

Enrollment: 29 patients

Sex: Male

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

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

Exclusion criteria

1. Chronic kidney disease stage 3b, 4 and 5 (eGFR < 30)
2. Insulin use
3. Oral steroids use (inhalers and creams are allowed)
4. Antibiotic use within the last month
5. Artificial heart valves
6. Hospitalization for chronic condition within 6 months prior to the study
7. 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.
8. Use of other antidiabetic drugs (except glipizide and metformin).
9. Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma.

Additional Exclusion criteria for subjects who previously used Metformin:

1. Previous severe allergic reaction to metformin hydrochloride, such as angioedema.
2. Previous Metformin intolerance causing significant diarrhea or GI-upset. Would not exclude participants who had history of mild diarrhea with metformin use.
3. Previous side effects that the subject feels were related to Metformin and the subject is not interested to re-try metformin.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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29 participants in 2 patient groups

Metformin ER

Active Comparator group

Description:

The subjects developing GI-related symptoms with metformin will be randomized to Metformin Extended Release (ER)

Treatment:

Drug: Metformin Extended Release Oral Tablet

Psyllium

Experimental group

Description:

The subjects developing GI-related symptoms with metformin will be randomized to Psyllium

Treatment:

Drug: Psyllium powder