腹膜透析患者のエネルギー代謝の測定 (CALIMERO 2)
自動腹膜透析で治療された腎障害患者のエネルギー代謝の比色室での研究
The daily energy expenditure of patients treated with peritoneal dialysis could be increased compared to the general population and promote the development of a state of undernutrition. Conversely, the absorption of glucose by transperitoneal route could contribute to the occurrence of a metabolic syndrome.
The main objective is to compare DE and its variations according to the conditions (rest, sleep, meals, physical activity) in patients treated with automated DP compared to controls, in a calorimetric chamber.
調査の概要
詳細な説明
The daily energy expenditure of patients treated with peritoneal dialysis could be increased compared to the general population and promote the development of a state of undernutrition. Conversely, the absorption of glucose by transperitoneal route could contribute to the occurrence of a metabolic syndrome.
The main objective is to compare DE and its variations according to the conditions (rest, sleep, meals, physical activity) in patients treated with automated DP compared to controls, in a calorimetric chamber.
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
-
-
-
Clermont-Ferrand、フランス、63003
- CHU Clermont-Ferrand
-
-
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:
-
Patients Group DPA
- Male patients
- Aged 18 to 70 years
- With end-stage renal disease
- Treated by automatic peritoneal
- Social security cover
- Without acute events in the 3 months prior to inclusion
- PCR < 30 mg/L
- Written informed consent
- Baecke activity score from 5 to 10
Healthy Volunteers
- Male patients
- Aged 18 to 70 years
- Patients matched by lean body mass (± 2 kgs) and age (± 5 years)
- Having a glomerular filtration rate estimated with the formula CKD-EPI creatinine > 60 mL / min / 1.73 m 2
- PCR < 3 mg/L
- Social security cover
- Written informed consent
- Baecke activity score from 5 to 10
Exclusion Criteria:
-
• - Female
- Type 1 or 2 diabetes requiring a antidiabetic treatment
- Decompensated heart failure
- Smoking more than 5 cigarettes a day
- Alcoholic patients, drinking more than 3 glass of alcohol a day
- Patient Corticotherapy in progress
- Patient with evolutive acute pathology
- Person who has participated in another study within the last 30 days or is in period of exclusion on the National File of Healthy Volunteers
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：診断
- 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 |
|---|---|
|
実験的：Patients Group DPA
The main objective is to compare DE and its variations according to the conditions (rest, sleep, meals, physical activity) in patients treated with automated DP compared to controls, in a calorimetric chamber |
Energy expenditure measurement |
|
実験的：Healthy Volunteers
The main objective is to compare DE and its variations according to the conditions (rest, sleep, meals, physical activity) in patients treated with automated DP compared to controls, in a calorimetric chamber |
The main objective is to compare DE and its variations according to the conditions (rest, sleep, meals, physical activity) in patients treated with automated DP compared to controls, in a calorimetric chamber |
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 |
|---|---|---|
|
Energy expenditure measured by indirect calorimetry in a calorimetric chamber
時間枠：at day 1
|
Energy expenditure measured by indirect calorimetry in a calorimetric chamber |
at day 1
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
respiratory quotient (RQ)
時間枠：at day1
|
Nature of the oxidized nutrients determined from the measurement of the respiratory quotient |
at day1
|
|
Actimetry
時間枠：at day 1
|
Estimated ambulatory energy expenditure from heart rate |
at day 1
|
|
HGPO
時間枠：at day 1
|
Charges of blood insulin concentration, and glucose in response to oral glucose load |
at day 1
|
協力者と研究者
捜査官
- 主任研究者：Julien ANIORT、University Hospital, Clermont-Ferrand
出版物と役立つリンク
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
追加の関連 MeSH 用語
その他の研究ID番号
- CHU-364
- 2015-A00035-44 (その他の識別子：2015-A00035-44)
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
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。