NCT04016012尚未招募不适用
Overweight and Obesity in Relation to Type II Melitus,Diabetes A Randomised Controlled Trial
Mukuba University1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2023年4月30日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Change in Blood glucose levels
研究概览
简要总结
The aim of the study is to evaluate the efficacy of local Zambian food in improving metabolic profiles of overweight/obese type ll diabetic patients in Kitwe district
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
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diabetic patients attending Kitwe Teaching Hospital
- •18 years and above
- •Body Mass Index of 25 and above
- •Willing to follow the diet plan and eat food provided
- •Not enrolled in other clinical studies
排除标准
- •Eating disorder or any psychosocial or scheduling factors that could impede study outcomes
- •Have renal or liver problem
- •Pregnant women
- •Breast feeding women
- •HIV positive individuals
研究组 & 干预措施
Intervention arm
Experimental
Participants in the intervention group will receive local zambian foods and standard health care for eight (8) weeks.
干预措施: Local Zambian Foods (Dietary Supplement)
Control arm
No Intervention
The control group will have their usual (standard) diet in their home and receive standard health care for eight (8) weeks.
结局指标
主要结局
Change in Blood glucose levels
时间窗: At baseline and 8 weeks
Fingertip blood sugar test using: blood glucose meter, test strips, lancet device, dry swabs, methylated spirit and a sharps box.
次要结局
- Change in Body weight(At baseline and 8 weeks)
- Change of Body Mass Index (BMI)(At baseline and 8 weeks)
研究者
Given Chipili
Dr
Mukuba University
研究点 (1)
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