Prader-Willi 症候群の成人における生物学的年齢評価 (ETABIOLPWS) (ETABIOLPWS)
統合された学際的な代謝リハビリテーションプログラムを受けているプラダーウィリー症候群の成人における生物学的年齢評価
The primary objective of the study is to compare, in a cohort of obese subjects with PWS hospitalized at the Division of Auxology, Istituto Auxologico Italiano, Piancavallo (VB), Italy, the age acceleration calculated at study entry (T0) with the age acceleration measured at the end of a 3-week multidisciplinary metabolic rehabilitation program (T1).
Secondary objectives are to correlate the biological age with the anthropometric characteristics (with particular reference to the body composition), the glycometabolic picture, the main parameters and cardiovascular risk factors, the therapy (previous and concomitant) with rhGH and the cognitive function (mainly, the IQ).
調査の概要
詳細な説明
Methods Thirty adults affected by clinically diagnosed and genetically confirmed PWS are recruited, regardless of the treatment (previous or concomitant) with rhGH (F/M = 15/15; age: ≥ 18 years; BMI > 35 kg/m2), hospitalized for a period of integrated multidisciplinary metabolic rehabilitation at the Division of Auxology, Istituto Auxologico Italiano, Piancavallo (VB), Italy.
After verifying the inclusion criteria, clinical and anthropometric data will be collected, including the evaluation of body composition with bioimpedance analysis. Cognitive function will be assessed with a psychometric scale (Wechsler Adult Intelligence Scale).
Blood samples will be taken from each patient upon admission to the hospital (T0) and after 3 weeks of rehabilitation hospitalization (at the same time to reduce circadian variability) for the determination of the basal glycometabolic profile (glucose, insulin, HOMA-IR, glycated Hb , triglycerides, total cholesterol, LDL, HDL, and hsPCR), as well as circulating levels of leptin, IL-6, and TNF-α.
The samples taken will be used for DNA extraction. DNA methylation will be performed by treatment with sodium bisulphite and PCR-Pyrosequencing.
Biological age measurement Biological (epigenetic) age will be measured using the two algorithms of Zbiec-Piekarska (9) and Daunay (10), based on the level of DNA methylation in specific gene loci. To have an estimate of the epigenetic (biological) age that is independent of the chronological age, we will use a measure defined as age acceleration, from which, with statistical inference, we will calculate the age acceleration. To calculate it, a linear regression model with the chronological age as the independent variable and the epigenetic age as the dependent variable will be applied; the difference between the observed value and the one predicted by the model will constitute the age acceleration due to epigenetic effects. In the event that the epigenetic age is greater than the chronological age, the age acceleration will have a positive value expressed in years, negative if vice versa.
研究の種類
入学 (実際)
連絡先と場所
研究場所
-
-
Verbania
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Oggebbio、Verbania、イタリア、28824
- Istituto Auxologico Italiano IRCCS, Site Piancavallo
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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
サンプリング方法
調査対象母集団
Adult patients with Prader-Willi syndrome with BMI > 35 kg/m2
説明
Inclusion Criteria:
- adult patients with PWS, clinically diagnosed and genetically confirmed, regardless of rhGH treatment (previous or concomitant)
- age: ≥ 18 years
- BMI > 35 kg/m2
- hospitalization for integrated multidisciplinary metabolic rehabilitation program
Exclusion Criteria:
- age < 18 years
- BMI < 35 kg/m2
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
- 観測モデル：COHORT
- 時間の展望：PROSPECTIVE
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 |
|---|---|---|
|
DNA methylation
時間枠：Baseline and at the end of the rehabilitation program (21 days)
|
Change in level of DNA methylation |
Baseline and at the end of the rehabilitation program (21 days)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Glycometabolic profile: glucose
時間枠：Baseline and at the end of the rehabilitation program (21 days)
|
Change in glycometabolic profile - glucose levels |
Baseline and at the end of the rehabilitation program (21 days)
|
|
Glycometabolic profile: insulin
時間枠：Baseline and at the end of the rehabilitation program (21 days)
|
Change in glycometabolic profile - insulin levels |
Baseline and at the end of the rehabilitation program (21 days)
|
|
Body fat mass
時間枠：Baseline and at the end of the rehabilitation program (21 days)
|
Change in body fat mass - bioimpedance analysis |
Baseline and at the end of the rehabilitation program (21 days)
|
|
Body fat free mass
時間枠：Baseline and at the end of the rehabilitation program (21 days)
|
Change in body fat free mass - bioimpedance analysis |
Baseline and at the end of the rehabilitation program (21 days)
|
|
Body weight
時間枠：Baseline and at the end of the rehabilitation program (21 days)
|
Change in body weight |
Baseline and at the end of the rehabilitation program (21 days)
|
|
Body mass index
時間枠：Baseline and at the end of the rehabilitation program (21 days)
|
Change in body mass index |
Baseline and at the end of the rehabilitation program (21 days)
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
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 (実際)
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
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- 01C213
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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