- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02204670
EXIT: Prospective Study of the Response to Exercise (EXIT)
Exercise and Irisin Trial (EXIT): Prospective Cohort Study of the Determinants of the Metabolic Response to Exercise in Obese Adolescents
Background :
Regular exercise is a cornerstone in the prevention and the management of comorbidities. Unfortunately, the metabolic benefit of exercise training is not universal and varies among individuals. A main factor likely to explain the exercise training variability is the lack of empirical evidence on the determinants of exercise training. A series of muscle-derived cytokines have recently been discovered that (1) are released during exercise and (2) exert positive effects on peripheral tissues. Irisin is one of these novel "myokines" and might contributes to the metabolic adaptations to exercise training.
Methods:
The investigators will perform a pilot cohort study in which obese adolescents will perform resistance exercise training for 6 weeks. The main exposure variable will be the acute release of irisin during resistance exercise. The main outcome measures will be the change in hepatic triglyceride content and glucose area under the curve during a 75g, 2-hour oral glucose tolerance test.
Study Hypothesis:
The primary overall hypothesis is that the change in plasma Irisin with a single bout of exercise will be associated with the metabolic adaptations to 6 weeks of resistance training, specifically, the reductions in hepatic triglyceride content and post-prandial glucose excursions, in obese adolescents.
연구 개요
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Winnipeg, 캐나다
- The Manitoba Institute of Child Health
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Adolescents (12-18 years)
- Body mass index considered obese according to the International Obesity Task Force
Exclusion Criteria:
- Adolescents with medication-induced or type 1 diabetes
- are currently being treated with corticosteroids or atypical antipsychotics, as these agents significantly influence carbohydrate metabolism
- have an orthopaedic injury or chronic illness that would prevent them from performing the intervention
- have experienced >10% weight loss or enrolled in weight loss program within six months of enrolment
- a history of alcoholism or drug abuse
- require use of medication(s) known to affect insulin sensitivity or secretion within the last 30 days
- medication(s) known to cause weight gain
- anabolic steroids
- weight loss medication(s)
- pregnant or planning to be pregnant
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
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Overweight Adolescents Performing Resistance Training
Overweight adolescents that meet pre-specified enrollment criteria will all undergo supervised resistance exercise for a 6-week period.
Prior to training, all participants will undergo a single bout of resistance training to determine the acute release of Irisin with resistance training.
This will be the primary exposure variable.
After the acute session, all participants will perform resistance training three times per week for a period of 4 weeks.
During each session participants will perform 3 sets of 8-12 repetitions (60-85% of 1RM) for major muscle groups (quadriceps, shoulders, and pectoral).
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We will determine the amount of Irisin secreted after a single bout of resistance exercise.
Participants will be stratified into 3 groups based on the degree of Irisin release during this acute bout of resistance exercise.
The metabolic adaptations to the 4 weeks of resistance training will be compared between youth stratified according to the amount of Irisin released during the acute bout of resistance exercise.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Hepatic Triglyceride Content
기간: 6 weeks
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Hepatic triglyceride content will be measured by using 1H magnetic resonance spectroscopy.
After image acquisition, a single voxel volume of interest will be placed in the upper right lobe of the liver in an area devoid of adipose tissue to acquire 1H spectra.
A total of 64 spectra will be collected and averaged to determine the intracellular triglyceride content.
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6 weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Post-prandial glucose
기간: 6 weeks
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Glucose area under the curve (AUC) will be determined by summing the area under serum glucose measures between each 15- or 30-min segment using the trapezium rule during a frequently sampled 75-g oral glucose challenge .
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6 weeks
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공동 작업자 및 조사자
수사관
- 수석 연구원: Jon M McGavock, PhD, University of Manitoba
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
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. .
간 지방에 대한 임상 시험
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University Hospital, Basel, Switzerland아직 모집하지 않음