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临床试验/NCT01985035
NCT01985035已完成不适用

Influence of Obstructive Sleep Apnea on Metabolism and Weight Loss in Obese Individuals

Federal University of São Paulo4 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2013年10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
60
试验地点
4
主要终点
Energy expenditure

研究概览

简要总结

Obstructive sleep apnea (OSA) can impars body weight reduction by changes in body composition and energy expenditure. The objective of this study is to evaluate the influence of OSA in energy metabolism and body mass loss in obese subjects. Ninety obese volunteers of both genders, 45 diagnosed with OSA and 45 without OSA, will be submitted to a dietary intervention of one months. Volunteers will be distributed into four groups: obese OSA PTN with moderate protein diet (1.6 g / kg protein / day), obese OSA CHO diet (0.8 g / kg protein / day) with standard composition diet, obese NSAOS PTN diet moderate in protein and CHO NSAOS obese standard diet. All groups will be instructed to perform a restricted energy diet (less 30% of daily energy expenditure). At baseline and one month after the beginning of the program the following evaluations will be conducted: total energy expenditure measured by doubly labeled water method, resting energy expenditure and thermic effect of food by calorimetry, polysomnography analysis, body composition by pletysmography, food consumption by three days of food diary, blood collection for analysis of lipid profile, visceral proteins, hormones related to control of body weight and inflammation. As hypothesis we believe that apneic obese individuals have greater difficult in weight loss and loss more free fat mass than the obese no apneic and that diets with more protein can contribute to greater weight loss, better body composition and energy expenditure in these population.

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 (Participant)

入排标准

年龄范围
25 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Body Mass Index between 30 and 40 kg/m2;
  • Obstructive sleep apnea mild or severe;
  • Sedentary.

排除标准

  • Intake of any drug that interfere on metabolism such for thyroid or to lose weight;
  • Be engaged in other treatment for sleep apnea or obesity;
  • Present another sleep disorder;
  • Being shift work;
  • Present any kind of kidney disease.

结局指标

主要结局

Energy expenditure

时间窗: up to 4 months

Measurements of energy expenditure by doubly labeled water for day energy expenditure and by calorimetry for resting energy expenditure and thermic effect of food

次要结局

  • Body Composition(Baseline, 1 month, 2 months and 4 months)

研究者

发起方
Federal University of São Paulo
申办方类型
Other
责任方
Principal Investigator
主要研究者

Camila Maria de Melo

Msc

Federal University of São Paulo

研究点 (4)

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