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Tolerance & Responsiveness Improvement for Metformin (TRIM) | Clinical Trials | Clareo Health

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Tolerance & Responsiveness Improvement for Metformin (TRIM)

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

NCT03670043•West Side Institute for Science and Education

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).

Eligibility

Age

20 - 70 years

Sex

MALE

Healthy Volunteers

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.
•1. Previous severe allergic reaction to metformin hydrochloride, such as angioedema.
+2 more criteria

Locations (1)

Jesse Brown VA Medical Center

Chicago, Illinois, United States

Key Dates

Start Date

March 19, 2019

Primary Completion Date

October 15, 2020

Completion Date

August 15, 2021

Last Updated

September 10, 2021

Enrollment

ACTUAL participants

Conditions

Type2 Diabetes Mellitus

Interventions

Psyllium powder

DRUG

Metformin Extended Release Oral Tablet

DRUG

Effects of Testosterone Undecanoate vs Placebo on Intrahepatic Fat Content in Overweight/Obese Men With T2DM or Prediabetes and Hypogonadism

NCT03851627

Fatty LiverOverweight/Obesity+2 more

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ACTIVE_NOT_RECRUITINGNA

Behavioral Chronotype: Impact on Sleep and Metabolism

NCT03647306

Type2 Diabetes MellitusCardiovascular Diseases

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 10, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Tolerance & Responsiveness Improvement for Metformin (TRIM)

Inclusion Criteria

Exclusion Criteria

Effects of Testosterone Undecanoate vs Placebo on Intrahepatic Fat Content in Overweight/Obese Men With T2DM or Prediabetes and Hypogonadism

Behavioral Chronotype: Impact on Sleep and Metabolism

A Phase 3 Study to Evaluate the Efficacy of JY09 Compared With Dulaglutide in Combination Therapy Diabetes Mellitus Type 2 Patients With Metformin

Observational Study on GER in Patients With Simple Obesity

Effects of Marching Exercise With Cognitive Training on Physical, Cognitive Function, and Autonomic Cardiovascular Responses in Older Adults With Type 2 Diabetes Mellitus

Orange Juice And Sugar Intervention Study