Department of Nutrition Science, Medical Faculty, Universitas Diponegoro, Semarang, Indonesia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- change PYY
研究概览
简要总结
Diabetes Mellitus individuals are known to have dietary rules, namely regulating the amount, type and time of eating. Ramadan fasting seems to be beneficial for people who want to reduce their weight, but it is not easy for diabetic patients. Because of its distinctive features, Ramadhan induces changes in eating habits, calorie consumption, sleeping patterns, and daily physical activity, which may contribute to changes in hunger-satiety responses and glicemic control. Examining changes in gut hormones during Ramadan fasting may reveal whether this observance could change glucose metabolism in diabetics without triggering the undesirable effect of gluconeogenesis. The proportions of fat, protein, and carbohydrate in meals vary between outside and within Ramadan. Alterations in timing and composition meal during Ramadan lead to reduced food intake may affect gut hormones and metabolic responses. The aim of this study to determine whether the effect of Ramadan fasting differed in people with DM patients, pre-DM and healthy individuals, with respect to gut hormones, body composition, metabolic parameters, and glycemic control
详细描述
The experimental study was performed during and after Ramadan fasting in 2021 (April to May) in Semarang, Indonesia. The present study was performed using the quasy-experimental method by pre-post measurement of three experimental groups (diabetics, Obese and healthy subjects) selected using the purposive sampling methods
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
subject with random allocation Investigator do not know the group the analysator do not know the group
入排标准
- 年龄范围
- 35 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diabetics subjects: glucose fasting plasma > 200 mg/dL, with aged 35-60 years and body mass index above 25 kg/m;
- •Obese subjects: body mass index above 25 kg/m2 with aged 35-60 years and waist circumference for men >90 cm, for women > 80 cm
- •Lean subjects: body mass index below 23.5 kg/m2 with aged 35-60 years and waist circumference for men <90 cm, for women < 80 cm
排除标准
- •experienced weight loss more than 10% from the actual weight in the last three months
- •consumed medicine or supplement for weight loss diet, •. had the history of evidence of clinical depression, cognitive disorders, heart disease, cancer, liver or renal disease, chronic pulmonary disease, uncontrolled hypertension, physical disability, or other contraindications
结局指标
主要结局
change PYY
时间窗: 30 days
Change from Baseline PYY at 30 days taken in the lab from venous blood specimen
change insulin
时间窗: 30 days
Change from Baseline Insulin at 30 days taken in the lab from venous blood specimen
change acylated ghrelin
时间窗: 30 days
Change from Baseline acyl ghrelin at 30 days taken in the lab from venous blood specimen
change GLP-1
时间窗: 30 days
Change from Baseline GLP-1 at 30 days taken in the lab from venous blood specimen
次要结局
- change body weight(30 days)
研究者
Etika Ratna Noer
Department of Nutrition, Medical Faculty
Universitas Diponegoro