Tolerance & Responsiveness Improvement for Metformin (TRIM)

Study Overview
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Brief Summary
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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).

Official Title
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Tolerance & Responsiveness Improvement for Metformin (TRIM): Open-label, Parallel-group Randomized Trial, Phase 4

Conditions
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Type2 Diabetes Mellitus

Intervention / Treatment
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* Drug: Psyllium powder
* Drug: Metformin Extended Release Oral Tablet


Participation Criteria
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Eligibility Criteria
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Inclusion criteria 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). 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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Metformin ER<br>The subjects developing GI-related symptoms with metformin will be randomized to Metformin Extended Release (ER) | Drug: Metformin Extended Release Oral Tablet<br>* Metformin Extended Release Oral Tablet is standard of care for diarrhea in patients taking metformin<br>|
| Experimental: Psyllium<br>The subjects developing GI-related symptoms with metformin will be randomized to Psyllium | Drug: Psyllium powder<br>* To evaluate whether Psyllium will alleviate diarrhea<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Birmingham Irritable Bowel Syndrome (IBS) Symptom Questionnaire | This scale is based on symptoms that frequently occur in IBS cases, examines abdominal discomfort status, stool properties, and defecation feelings. The scale includes a total of 11 items, with 6 possible grades for each item that range from 0 points (never having this symptom) to 5 points (the symptom is always present). The total score is the sum of the scores for each item. The Total score is used. No subscale is used. Total range is minimum=0, maximum=55. The higher values represent a worse outcome. | 3 months |