Metformin, The Biguanide Derivative, as Adjuvant Therapy in Patients With Ulcerative Colitis Treated With Mesalamine
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Improvement in HRQL through changes in inflammatory bowel disease questionnaire (IBDQ) score and change in mayo scores
研究概览
简要总结
Ulcerative colitis (UC) is a chronic inflammatory bowel disease that is marked by increased intestinal motility and bloody diarrhea. The clinical value of existing therapeutic strategies of UC, including glucocorticoids, anti-tumor necrosis factor α (TNF-α), mesalamine, and thiopurines is still limited. Therefore, the discovery of new therapeutic approaches is essential to improve the effectiveness of the treatment.Adenosine monophosphate (AMP)-activated protein kinase (AMPK) is a conserved fuel-sensing enzyme that plays an important role in the regulation of cellular metabolism where it increases glucose and fatty acids uptake and activates the oxidation process to improve the cellular energy utilization
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
- Double (Participant, Care Provider)
盲法说明
double-blinded
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years Both males and females will be included Negative pregnancy test and effective contraception Mild and moderate UC patients diagnosed and confirmed by the endoscope
排除标准
- •Breastfeeding Significant liver and kidney function abnormalities Diabetic patients Colorectal cancer patients Patients with severe UC Patients taking rectal or systemic steroids
研究组 & 干预措施
Metformin group
This group will take mesalamine 1 g three times daily plus metformin 500 mg two times daily
干预措施: Metformin (Drug)
结局指标
主要结局
Improvement in HRQL through changes in inflammatory bowel disease questionnaire (IBDQ) score and change in mayo scores
时间窗: 6 months
The IBDQ includes 32 questions, The questions are grouped into four categories: bowel symptoms (B), systemic symptoms (S), emotional function (E), and social function (SF). Response options are consistently presented as seven-point scales, scores range from 32-224.
次要结局
未报告次要终点
研究者
Mostafa Bahaa
Teaching Assistant
Tanta University