Tolerance & Responsiveness Improvement for Metformin (TRIM)

Type2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03670043
• Other study ID #: 1005965
• Status: Completed
• Phase: Phase 4
• Start date: March 19, 2019
• Est. completion date: August 15, 2021

Study information

• Verified date: September 2021
• Source: West Side Institute for Science and Education
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: August 15, 2021
• Est. primary completion date: October 15, 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type2 Diabetes Mellitus

Intervention

Drug:
• Psyllium powder
To evaluate whether Psyllium will alleviate diarrhea
• Metformin Extended Release Oral Tablet
Metformin Extended Release Oral Tablet is standard of care for diarrhea in patients taking metformin

Locations

Country	Name	City	State
United States	Jesse Brown VA Medical Center	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
West Side Institute for Science and Education

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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