복막투석 환자의 에너지 대사량 측정 (CALIMERO 2)
자동복막투석을 받는 신장애 환자의 에너지대사 열량측정실 연구
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.
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
-
Clermont-Ferrand, 프랑스, 63003
- CHU Clermont-Ferrand
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 특수 증상
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 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 |
|
실험적: 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 |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Energy expenditure measured by indirect calorimetry in a calorimetric chamber
기간: at day 1
|
Energy expenditure measured by indirect calorimetry in a calorimetric chamber |
at day 1
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
respiratory quotient (RQ)
기간: at day1
|
Nature of the oxidized nutrients determined from the measurement of the respiratory quotient |
at day1
|
|
Actimetry
기간: at day 1
|
Estimated ambulatory energy expenditure from heart rate |
at day 1
|
|
HGPO
기간: at day 1
|
Charges of blood insulin concentration, and glucose in response to oral glucose load |
at day 1
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Julien ANIORT, University Hospital, Clermont-Ferrand
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- CHU-364
- 2015-A00035-44 (기타 식별자: 2015-A00035-44)
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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