Tolerance & Responsiveness Improvement for Metformin (TRIM): Open-label, Parallel-group Randomized Trial, Phase 4
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Birmingham Irritable Bowel Syndrome (IBS) Symptom Questionnaire
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Metformin ER
The subjects developing GI-related symptoms with metformin will be randomized to Metformin Extended Release (ER)
干预措施: Metformin Extended Release Oral Tablet (Drug)
Psyllium
The subjects developing GI-related symptoms with metformin will be randomized to Psyllium
干预措施: Psyllium powder (Drug)
结局指标
主要结局
Birmingham Irritable Bowel Syndrome (IBS) Symptom Questionnaire
时间窗: 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.
次要结局
未报告次要终点
研究者
Brian T. Layden, M.D., Ph.D.
Chief, Section of Endocrinology
Jesse Brown VA Medical Center