Tolerance & Responsiveness Improvement for Metformin (TRIM)
NCT ID: NCT03670043
Last Updated: 2021-09-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
29 participants
INTERVENTIONAL
2019-03-19
2021-08-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Metformin ER
The subjects developing GI-related symptoms with metformin will be randomized to Metformin Extended Release (ER)
Metformin Extended Release Oral Tablet
Metformin Extended Release Oral Tablet is standard of care for diarrhea in patients taking metformin
Psyllium
The subjects developing GI-related symptoms with metformin will be randomized to Psyllium
Psyllium powder
To evaluate whether Psyllium will alleviate diarrhea
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
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
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. 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.
20 Years
70 Years
MALE
No
Sponsors
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West Side Institute for Science and Education
OTHER
Responsible Party
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Brian T. Layden, M.D., Ph.D.
Chief, Section of Endocrinology
Principal Investigators
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Barengolts
Role: PRINCIPAL_INVESTIGATOR
Jesse Brown VA Medical Center
Locations
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Jesse Brown VA Medical Center
Chicago, Illinois, United States
Countries
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Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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1005965
Identifier Type: -
Identifier Source: org_study_id
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