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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metformin ER | Active Comparator | The subjects developing GI-related symptoms with metformin will be randomized to Metformin Extended Release (ER) |
|
| Psyllium | Experimental | The subjects developing GI-related symptoms with metformin will be randomized to Psyllium |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Psyllium powder | Drug | To evaluate whether Psyllium will alleviate diarrhea |
| |
| 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 |
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Inclusion criteria
Exclusion criteria
Additional Exclusion criteria for subjects who previously used Metformin:
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| Name | Affiliation | Role |
|---|---|---|
| Barengolts | Jesse Brown VA Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jesse Brown VA Medical Center | Chicago | Illinois | 60612 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Sep 21, 2020 | Sep 1, 2021 | ICF_000.pdf |
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| Metformin Extended Release Oral Tablet |
| Drug |
Metformin Extended Release Oral Tablet is standard of care for diarrhea in patients taking metformin |
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