| Trial ID: | L4726 |
| Source ID: | NCT03670043
|
| Associated Drug: |
Psyllium Powder
|
| Title: |
Tolerance & Responsiveness Improvement for Metformin (TRIM)
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type2 Diabetes Mellitus
|
| Interventions: |
DRUG: Psyllium powder|DRUG: Metformin Extended Release Oral Tablet
|
| Outcome Measures: |
Primary: 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 |
|
| Sponsor/Collaborators: |
Sponsor: West Side Institute for Science and Education
|
| Gender: |
MALE
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
29
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2019-03-19
|
| Completion Date: |
2021-08-15
|
| Results First Posted: |
|
| Last Update Posted: |
2021-09-10
|
| Locations: |
Jesse Brown VA Medical Center, Chicago, Illinois, 60612, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT03670043
|
