The Effects of Calorie Restriction With or Without Metformin on Weight and Insulin Resistance
The Effects of Calorie Restriction - Whether or Not Calculated Based on BMR (Basic Metabolic Rate) - With or Without Metformin on Weight and Insulin Resistance of Obese Insulin Resistant Patients
This is a study to:
- Determine the difference between strong hypo-energetic "standard diet advice" and modest hypo-energetic "personal diet advice"; and
- Determine the influence of insulin-insensitivity on obesity and weight reduction by treating patients with metformin or placebo.
研究概览
详细说明
The aim of the present study was to determine what the difference is of a strong hypo-energetic "standard diet advice" and a modest hypo-energetic "personal diet advice" which was determined by the energy needs of a person as calculated with a combination of basal metabolic rate (BMR) and physical activity level (PAL) on weight loss and insulin sensitivity.
Secondly, this study wanted to determine what the influence is of insulin-insensitivity on obesity and weight reduction by treating the patients with metformin or placebo. The subjects were therefore randomised into two double blinded groups receiving either metformin (2 x 850 mg per day) or placebo in combination with a moderate energy restriction and a exercise regimen of 30 minutes per day for 1 year.
Treatment effects of both diets and the effect of metformin on weight reduction and insulin sensitivity were determined after a treatment period of 20 and 52 weeks.
Insulin sensitivity was quantified using the homeostasis model assessment (HOMA) and the OGTT. Body composition was determined with the bioelectrical impedance method.
Blood was also drawn for hormonal and biochemical analyses after 20 and 52 weeks of treatment. Furthermore, the patients had to fill out a 3-day food diary at baseline, after 20 weeks and after 52 weeks.
研究类型
注册
阶段
- 第四阶段
联系人和位置
学习地点
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Ghent、比利时、9000
- University Hospital Ghent
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 20-55 years of age
- Body mass index (BMI) equal to or greater than 30 kg/m²
- Insulin resistance as determined by oral glucose tolerance test (OGTT) and HOMA
Exclusion Criteria:
- Diabetes mellitus, kidney insufficiency, or hepatic insufficiency
- Hypogonadism with other etiology than overweight
- Pregnancy
- BMI equal to or greater than 40 kg/m²
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:双倍的
研究衡量的是什么?
主要结果指标
结果测量 |
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Effect of diet on weight and insulin sensitivity/insulin resistance after 20 and 52 weeks of treatment
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次要结果测量
结果测量 |
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Effect of metformin on weight and insulin resistance after 20 and 52 weeks of treatment
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合作者和调查者
调查人员
- 首席研究员:Mimi Giri, MD, PhD、University Hospital, Ghent
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
二甲双胍的临床试验
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Poznan University of Medical SciencesUniversity of California, San Diego未知
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Boehringer IngelheimEli Lilly and Company完全的
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Boehringer IngelheimEli Lilly and Company完全的