- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02601482
Optimization of Interval-training in Patients With Type 2 Diabetes
A single bout of Interval-Walking (IW) exercise is superior to energy-expenditure and time-duration matched Continuous Walking (CW) exercise upon improving glycemic control. The time spend with high-intensity (fast) walking is considered to be responsible for the improvements seen, whereas the time spend with low-intensity (slow) walking is considered less important.
This study will assess if IW with maintained fast walking time duration but reduced total time duration (i.e. reduced slow walking time duration) is equally effective as IW with a normal time duration.
Subjects with type 2 diabetes will be included in a crossover, controlled study, where each subject will undergo three trials. Trials will be identical except the following interventions:
- Sixty minutes of rest (CON)
- Sixty minutes of classical interval walking (repeated cycles of 3 minutes of fast and 3 minutes of slow walking; IW-60)
- Fourty-five minutes of time-reduced interval walking (repeated cycles of 3 minutes of fast and 1.5 minutes of slow walking; IW-45).
After the interventions subjects will undergo a standardized mixed meal tolerance test with assessment of glycemic control.
연구 개요
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Copenhagen, 덴마크, 2100
- Center for Physical Activity Research (CFAS)
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Type 2 Diabetes Mellitus
- BMI > 25
Exclusion Criteria:
- Pregnancy
- Smoking
- Contraindication to increased levels of physical activity
- Eating disorder
- Insulin dependence
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위화되지 않음
- 중재 모델: 크로스오버 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Control (CON)
No exercise intervention.
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실험적: Normal Interval Walking (IW-60).
Sixty minutes with repeated cycles of 3 minutes of fast and 3 minutes of slow walking on a treadmill
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실험적: Time-reduced Interval Walking (IW-45)
Forty-five minutes with repeated cycles of 3 minutes of fast and 1.5 minutes of slow walking on a treadmill
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Glycemic control
기간: Within the first 4 hours after the intervention
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Glycemic control will be assessed after each intervention.
Subjects will receive a standardized mixed meal tolerance test (MMTT), and blood glucose values will be obtained during the test.
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Within the first 4 hours after the intervention
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Matsuda insulin sensitivity index
기간: Within the first 4 hours after the intervention
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From the measurements of glucose and insulin during the MMTT, the Matsuda index of insulin sensitivity will be assessed.
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Within the first 4 hours after the intervention
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Stumvoll insulin sensitivity index
기간: Within the first 4 hours after the intervention
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From the measurements of glucose and insulin during the MMTT, the Stumvoll index of insulin sensitivity will be assessed.
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Within the first 4 hours after the intervention
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Cederholm insulin sensitivity index
기간: Within the first 4 hours after the intervention
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From the measurements of glucose and insulin during the MMTT, the Cederholm index of insulin sensitivity will be assessed.
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Within the first 4 hours after the intervention
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HOMA-2 insulin resistance index
기간: Within the first 4 hours after the intervention
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From the measurements of glucose and insulin during the MMTT, the HOMA-2 index of insulin resistance will be assessed.
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Within the first 4 hours after the intervention
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
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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