NCT02412774已完成不适用
Effects of Replacing Diet Beverages With Water on Type 2 Diabetic Obese Females Attending a Weight Loss Program - a Randomized, 24 Week Clinical Trial
Novindiet Clinic2 个研究点 分布在 2 个国家目标入组 81 人开始时间: 2015年4月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 81
- 试验地点
- 2
- 主要终点
- Weight loss
研究概览
简要总结
The purpose of the present study is to evaluate the effect of replacing diet beverages with water on weight loss and biochemical indicators for insulin sensitivity and cardiometabolic risk factors of diabetic obese and overweight female adults when they are in a multidisciplinary weight loss plan.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diabetic female patient with 6.5<H1AC<7.
- •Monotherapy with Metformin.
- •18-45 years of age.
- •Body mass index (BMI) between 27-35 kg/ m².
- •Consume DBs regularly during their habitual diet.
- •Must be able to have moderate exercise.
- •Must be interested to have weight loss.
排除标准
- •Participating in a research project involving weight loss or physical activity in the previous six months.
- •Pregnancy or lactation during the previous 6 months, or planned pregnancy in the next six months.
- •Taking medication that could affect metabolism or change body weight.
- •Report heart problems, chest pain, and cancer within the last five years.
- •Unwilling to change intake of beverages during the study period.
结局指标
主要结局
Weight loss
时间窗: 24 weeks
次要结局
- HA1C(24 Weeks)
- Fasting plasma glucose(24 weeks)
- Waist circumference(24 weeks)
- Lipid profiles(24 weeks)
- BMI(24 Weeks)
- Insulin resistance (HOMA)(24 weeks)
研究者
研究点 (2)
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