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临床试验/NCT02161926
NCT02161926
已完成
不适用

Dietary Restrictions Implications on Metabolic Changes in Obese Men : Comparison Between Two Groups of Different Ages (60-70 Years Old Versus 30-40 Years Old)

University Hospital, Toulouse2 个研究点 分布在 1 个国家目标入组 71 人2014年5月1日
适应症Obesity

概览

阶段
不适用
干预措施
dietary restrictions
疾病 / 适应症
Obesity
发起方
University Hospital, Toulouse
入组人数
71
试验地点
2
主要终点
Lipolysis at resting and during physical activity test
状态
已完成
最后更新
23天前

概览

简要总结

The prevalence of obesity is growing in elderly with heavy consequences in term of medical complications and mortality, so that this is nowadays an important public health issue.

The major therapeutic solution is dietary restrictions, but and the advantages and the metabolic consequences are not well known in elderly. The MONA study main aim is to assess the metabolic changes in this population, after dietary restrictions, compared to young people.

详细描述

Primary endpoint : Study the metabolic adaptations of the subcutaneous adipose tissue after a diet in elderly obese men compared to young obese men. Secondary endpoints : Study the metabolic adaptations of skeletal muscle, the genetic adaptations of subcutaneous adipose tissue and skeletal muscle, the inflammatory and fibrosis modifications of subcutaneous adipose tissue, the insulinosensibility modifications, the modifications on the physical composition, modifications of the energy expenditure in resting state and the oxidation of the substrata, study the lipoproteins metabolism and identify new biomarkers. All those endpoints are studied comparing elderly obese subjects versus young obese subjects.

注册库
clinicaltrials.gov
开始日期
2014年5月1日
结束日期
2017年2月1日
最后更新
23天前
研究类型
Interventional
研究设计
Parallel
性别
Male

研究者

责任方
Sponsor

入排标准

入选标准

  • 30 \< years old \< 40 OR 60 \< years old \< 70
  • obesity : 30 \< BMI \< 40
  • stable blood pressure (diastolic \<90mmHg, systolic \< 140mmHg)
  • glycemia \< 1,26g/L, LDL cholest \<1,9-1,6g/L, Triglycerides \<2,5g/L
  • risk factors concerning high blood pressure, diabetes and dyslipidemia under control

排除标准

  • Insulin dependent diabetes, non-insulin dependent diabetes
  • high blood pressure
  • dyslipidemia
  • history of cardiovascular diseases or bariatric surgery
  • undernutrition
  • HbA1C \>7%
  • non authorized treatments : Glucagon-like peptide-1 agonists,
  • incapacity to do physical activity

研究组 & 干预措施

obese men from 60 to 70 years old

Dietary restrictions in obese men (30\<Body Mass Index\<40 kg/m2)

干预措施: dietary restrictions

obese men from 30 to 40 years old

Dietary restrictions in obese men (30\<Body Mass Index\<40 kg/m2)

干预措施: dietary restrictions

结局指标

主要结局

Lipolysis at resting and during physical activity test

时间窗: Change after 8 weeks dietary restrictions

Determine lipolysis at resting and during physical activity test by microdialysis, before dietary restrictions and after dietary restrictions (20% dietary restrictions)

次要结局

  • Metabolic parameters in skeletal muscle(Change after 8 weeks dietary restrictions)
  • Genetic markers(Change after 8 weeks dietary restrictions)
  • insulinosensibility(Change after 8 weeks dietary restrictions)
  • Fibrosis and inflammatory markers in adipose tissue(Change after 8 weeks dietary restrictions)
  • Fat and muscles rates in the whole body(Change after 8 weeks dietary restrictions)
  • Lipoproteins metabolism(Change after 8 weeks dietary restrictions)
  • biomarkers identification(Change after 8 weeks dietary restrictions)
  • Energetic consumption(Change after 8 weeks dietary restrictions)

研究点 (2)

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