- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01349166
Effects of 3 Months of Supervised Exercise Training
Effects of 3 Months of Supervised Exercise Training on Cardiometabolic and Inflammatory Biomarkers According to Glucose Tolerance (Normal, Intolerance and Type 2 Diabetes): Measures in Unstimulated and Stimulated Conditions
The incidence of type 2 diabetes is increasing worldwide. Because of cardiovascular morbidity and mortality associated with type 2 diabetes, it is imperative to propose methods of prevention and this in early stage of abnormal glucose metabolism.
This study will assess the beneficial effects of physical activity (acute and chronic effects) (the subjects being their own controls) on cardiometabolic and inflammatory biomarkers in 3 conditions : unstimulated (fasting and resting conditions) and stimulated conditions: postprandial response to a standardized meal preceded or not by an exercise bout.
The investigators hypothesized that an acute bout of exercise will decrease the postprandial inflammatory response to a standardized meal and that this effect of exercise will be increased after 3 months of exercise training.
연구 개요
상세 설명
This is a prospective study over 4 months, open, nonrandomized. 45 overweight or obese male subjects will complete 3 experimental sessions (0700-1400h) before and after 3 months of supervised physical training. During a first session, subjects will remain inactive and fasted (basal conditions). During the second session a standardized meal will be offered (postprandial response to a standardized meal). The third session will consist in the realization of an exercise bout (60min at 60%VO2 max) followed by a standardized meal (same meal that the previous day).
Several blood (catheter), salivary and urinary samples will be collected during the 3 sessions, throughout the experimental day.
연구 유형
등록 (예상)
단계
- 해당 없음
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Male Caucasian Adults between 30 and 65 years old Sedentary criteria based on the determination of fasting glucose (WHO 1999):
- normal if fasting plasma glucose (FPG) <1.10 g / l
- diabetes if fasting glucose> 1.26 g / l (7 mmol / l) twice
- nondiabetic fasting hyperglycemia: 1.10 g / l ≤ FPG ≤ 1.26 g / l
- glucose intolerance : if plasma glucose at 120 minutes during the OGTT (75g) is between 1.40 g / l and 2 g/ l.
Body mass index 25 BMI 35kg/m2 Affiliated to National Health Insurance Subject giving his written informed consent Subject considered as normal after clinical examination and medical questionnaire
Exclusion Criteria:
- - drugs that interfere with the parameters determined
- diabetic treated with insulin, glitazones or glinides
- eating disorders like bulimia and vomiting
- special diet, vegan or vegetarian
- autoimmune disease or inflammatory progressive desease requiring prolonged treatment
- regular physical activity (> 1 hour of physical activity per week for at least 6 months)
- smoking (> 5 cigarettes / day)
- weight change greater than 5% of the total weight in the 3 months preceding the study
- contra-indication to physical activity
- chronic pathologies: cancer, inflammatory, cardiac, pulmonary, renal, gastrointestinal or liver diseases
- Being in exclusion on the National Volunteers Data file
- No one under guardianship or not subject to social security.
- Being under someone's supervision
- Subjects deprived of their liberty by judicial or administrative.
- Refusal to sign the information sheet and written consent for particip
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
supervised physical training on cardiometabolic and inflammatory biomarkers
기간: after 3 months
|
after 3 months
|
2차 결과 측정
결과 측정 |
기간 |
|---|---|
|
relationships between cortisol secretion and the postprandial inflammatory responses depending on the level of glucose tolerance
기간: after 3 months
|
after 3 months
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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