Tolerance & Responsiveness Improvement for Metformin (TRIM)
Maneno muhimu
Kikemikali
Tarehe
| Imethibitishwa Mwisho: | 04/30/2020 |
| Iliyowasilishwa Kwanza: | 09/10/2018 |
| Uandikishaji uliokadiriwa Uliwasilishwa: | 09/10/2018 |
| Iliyotumwa Kwanza: | 09/12/2018 |
| Sasisho la Mwisho Liliwasilishwa: | 05/20/2020 |
| Sasisho la Mwisho Lilichapishwa: | 05/21/2020 |
| Tarehe halisi ya kuanza kwa masomo: | 03/18/2019 |
| Tarehe ya Kukamilisha Msingi iliyokadiriwa: | 02/28/2022 |
| Tarehe ya Kukamilisha Utafiti: | 02/28/2023 |
Hali au ugonjwa
Uingiliaji / matibabu
Drug: Psyllium
Drug: Metformin ER
Awamu
Vikundi vya Arm
| Mkono | Uingiliaji / matibabu |
|---|---|
| Active Comparator: Metformin ER The subjects developing GI-related symptoms with metformin will be randomized to Metformin Extended Release (ER) | Drug: Metformin ER Metformin Extended Release Oral Tablet is standard of care for diarrhea in patients taking metformin |
| Experimental: Psyllium The subjects developing GI-related symptoms with metformin will be randomized to Psyllium | Drug: Psyllium To evaluate whether Psyllium will alleviate diarrhea |
Vigezo vya Kustahiki
| Zama zinazostahiki Kujifunza | 20 Years Kwa 20 Years |
| Jinsia Inastahiki Kujifunza | Male |
| Hupokea Wajitolea wa Afya | Ndio |
| Vigezo | 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. |
Matokeo
Hatua za Matokeo ya Msingi
1. Birmingham Irritable Bowel Syndrome (IBS) Symptom Questionnaire [3 months]
