Assessments of Dietary Restrictions in Young and Elderly Obese Men : Metabolism Obesity Nutrition Age (MONA)
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)
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.
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Toulouse、フランス、31 059
- University Hospital TOULOUSE
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：非ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：obese men from 60 to 70 years old
Dietary restrictions in obese men (30<Body Mass Index<40 kg/m2)
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Dietary restrictions during 8 weeks
他の名前：
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アクティブコンパレータ：obese men from 30 to 40 years old
Dietary restrictions in obese men (30<Body Mass Index<40 kg/m2)
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Dietary restrictions during 8 weeks
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Lipolysis at resting and during physical activity test
時間枠：Change after 8 weeks dietary restrictions
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Determine lipolysis at resting and during physical activity test by microdialysis, before dietary restrictions and after dietary restrictions (20% dietary restrictions)
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Change after 8 weeks dietary restrictions
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Metabolic parameters in skeletal muscle
時間枠：Change after 8 weeks dietary restrictions
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To assess metabolic parameters before dietary restrictions and after dietary restrictions (20 % dietary restrictions)
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Change after 8 weeks dietary restrictions
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Genetic markers
時間枠：Change after 8 weeks dietary restrictions
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To assess genetic markers in adipose tissue and skeletal tissue before dietary restrictions and after dietary restrictions
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Change after 8 weeks dietary restrictions
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Fibrosis and inflammatory markers in adipose tissue
時間枠：Change after 8 weeks dietary restrictions
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To assess markers in adipose tissue before dietary restrictions and after dietary restrictions (20 % dietary restrictions)
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Change after 8 weeks dietary restrictions
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insulinosensibility
時間枠：Change after 8 weeks dietary restrictions
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To determine insulinosensibility before dietary restrictions and after dietary restrictions (20 % dietary restrictions)
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Change after 8 weeks dietary restrictions
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Fat and muscles rates in the whole body
時間枠：Change after 8 weeks dietary restrictions
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To determine fat and muscles rates by Dexa before dietary restrictions and after dietary restrictions
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Change after 8 weeks dietary restrictions
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Energetic consumption
時間枠：Change after 8 weeks dietary restrictions
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energetic consumption at resting and during physical activity, before dietary restrictions and after dietary restrictions
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Change after 8 weeks dietary restrictions
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Lipoproteins metabolism
時間枠：Change after 8 weeks dietary restrictions
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Before dietary restrictions and after dietary restrictions
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Change after 8 weeks dietary restrictions
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biomarkers identification
時間枠：Change after 8 weeks dietary restrictions
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New urinary and intestinal biomarkers identification, before dietary restrictions and after dietary restrictions
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Change after 8 weeks dietary restrictions
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協力者と研究者
捜査官
- 主任研究者：Claire Thalamas, MD PhD、University Hospital, Toulouse
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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