NCT03726762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 1 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
干预措施
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 present study aimed to follow up our participants in order to consider the changes in weight and anthropometric measurements after the 12-month weight maintenance as well as the total of 18 months, consisting of the previously described 24 weeks active weight loss and a further 53 weeks weight maintenance. The secondary outcome was to compare the abdominal adiposity, carbohydrate, and lipid metabolism during these periods.
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.
研究组 & 干预措施
Diet Beverages
Experimental
'Diet beverages' after the main meal
干预措施: DBs at the end of the main meal + weight control program (Behavioral)
Water
Experimental
'Water' after the main meal
干预措施: Water at the end of the main meal+ weight control program (Behavioral)
结局指标
主要结局
Weight loss
时间窗: 77 weeks
次要结局
- HA1C(77 Weeks)
- Insulin resistance (HOMA)(77 weeks)
- BMI(77 Weeks)
- Fasting plasma glucose(77 weeks)
- Waist circumference(77 weeks)
- Lipid profiles(77 weeks)
研究者
研究点 (2)
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