Tolerance & Responsiveness Improvement for Metformin (TRIM)
- Conditions
- Type2 Diabetes Mellitus
- Interventions
- Registration Number
- NCT03670043
- Lead Sponsor
- West Side Institute for Science and Education
- Brief 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 29
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Metformin ER Metformin Extended Release Oral Tablet The subjects developing GI-related symptoms with metformin will be randomized to Metformin Extended Release (ER) Psyllium Psyllium powder The subjects developing GI-related symptoms with metformin will be randomized to Psyllium
- Primary Outcome Measures
Name Time Method Birmingham Irritable Bowel Syndrome (IBS) Symptom Questionnaire 3 months 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Jesse Brown VA Medical Center
🇺🇸Chicago, Illinois, United States