Tolerance & Responsiveness Improvement for Metformin (TRIM)

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

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).

Study Overview

• Status: Completed
• Conditions: Type2 Diabetes Mellitus
• Intervention / Treatment: Drug: Metformin Extended Release Oral Tablet; Drug: Psyllium powder

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Jesse Brown VA Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: West Side Institute for Science and Education
• Investigators: Principal Investigator: Barengolts, Jesse Brown VA Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): March 19, 2019
• Primary Completion (Actual): October 15, 2020
• Study Completion (Actual): August 15, 2021

Study Registration Dates

• First Submitted: September 11, 2018
• First Submitted That Met QC Criteria: September 11, 2018
• First Posted (Actual): September 13, 2018

Study Record Updates

• Last Update Posted (Actual): September 10, 2021
• Last Update Submitted That Met QC Criteria: September 1, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Gastrointestinal Agents; Cathartics; Metformin; Psyllium
• Other Study ID Numbers: 1005965

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes