Type2 Diabetes Mellitus
Conditions
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).
Interventions
DRUGPsyllium powder
To evaluate whether Psyllium will alleviate diarrhea
Metformin Extended Release Oral Tablet is standard of care for diarrhea in patients taking metformin
Sponsors
West Side Institute for Science and Education
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
20 Years to 70 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed