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Tolerance & Responsiveness Improvement for Metformin (TRIM)

Sponsor
West Side Institute for Science and Education (Other)
Overall Status
Completed
CT.gov ID
NCT03670043
Collaborator
(none)
29
Enrollment
1
Location
2
Arms
28.9
Actual Duration (Months)
1
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Drug: Psyllium powder
  • Drug: Metformin Extended Release Oral Tablet
 Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
29 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Tolerance & Responsiveness Improvement for Metformin (TRIM): Open-label, Parallel-group Randomized Trial, Phase 4
Actual Study Start Date :
Mar 19, 2019
Actual Primary Completion Date :
Oct 15, 2020
Actual Study Completion Date :
Aug 15, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 70 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No

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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Jesse Brown VA Medical Center Chicago Illinois United States 60612

Sponsors and Collaborators

  • West Side Institute for Science and Education

Investigators

  • Principal Investigator: Barengolts, Jesse Brown VA Medical Center

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Brian T. Layden, M.D., Ph.D., Chief, Section of Endocrinology, Jesse Brown VA Medical Center
ClinicalTrials.gov Identifier:
NCT03670043
Other Study ID Numbers:
  • 1005965
First Posted:
Sep 13, 2018
Last Update Posted:
Sep 10, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
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
Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Metformin
Psyllium

Study Results

No Results Posted as of Sep 10, 2021