- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02951260
The Effects of Metformin on Self-selected Exercise Intensity, Physical Fitness and Exercise-induced AMPK-activation
연구 개요
상세 설명
Physical activity is a first line treatment for patients with type 2 diabetes (T2D ), however, the vast majority of patients with T2D do not achieve satisfying glycemic control with physical activity alone, which is why pharmacological treatment with metformin is most often initiated. It is known that metformin and exercise both activates AMPK, which results in many different metabolic effects. Because of this similarity, an interaction between metformin and exercise is plausible, but knowledge in the area is sparse. With this study the investigators aim to look at the individual and combined effects of metformin and exercise in order to investigate whether an interaction occur. An Interaction will have tremendous clinical importance for patients with T2D given current guidelines where the vast majority of these patients are recommended both exercise and metformin treatment.
The investigators hypothesize that metformin treatment reduces self-selected exercise intensity, which may be explained via decreased mitochondrial complex 1 function, increased blood lactate levels, heart rate and RPE during exercise. Furthermore exercise-induced AMPK-activation is reduced with metformin treatment.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
Copenhagen N
-
Copenhagen, Copenhagen N, 덴마크, 2200
- Center for aktiv sundhed
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- male
- HbA1c < 39 mmol/l
- BMI < 25
- structured physical activity < = 150 min/week
- apparently healthy
Exclusion Criteria:
- smoking
- daily pharmaceutical treatment
- contraindication to increased levels of physical activity
- ALAT/ASAT elevated 3 times above upper normal values
- renal insufficiency (eGFR < 60 ml/min)
- prior history of lactic acidosis
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: Metformin
17 days metformin treatment
|
17 days treatment with metformin
|
위약 비교기: Placebo
17 days placebo treatment
|
17 days treatment with placebo
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
---|---|
Overall aerobic work performed during an exercise bout with self-selected intensity
기간: Total oxygen consumption (L O2) during a 45 min ergometer cycling bout with self-selected intensity
|
Total oxygen consumption (L O2) during a 45 min ergometer cycling bout with self-selected intensity
|
2차 결과 측정
결과 측정 |
기간 |
---|---|
External work performed during an exercise bout with self-selected intensity
기간: Total work produced (kJ) during a 45 min ergometer cycling bout with self-selected intensity
|
Total work produced (kJ) during a 45 min ergometer cycling bout with self-selected intensity
|
Rate of perceived exertion during an exercise bout with fixed intensity
기간: Mean rate of perceived exertion (Borg scale) during a 45 min ergometer cycling bout with fixed intensity
|
Mean rate of perceived exertion (Borg scale) during a 45 min ergometer cycling bout with fixed intensity
|
blood lactate during an exercise bout with fixed intensity
기간: Mean blood lactate (mmol/l) during a 45 min ergometer cycling bout with fixed intensity
|
Mean blood lactate (mmol/l) during a 45 min ergometer cycling bout with fixed intensity
|
Heartrate during an exercise bout with fixed intensity
기간: Mean heart rate (bpm) during a 45 min ergometer cycling bout with fixed intensity
|
Mean heart rate (bpm) during a 45 min ergometer cycling bout with fixed intensity
|
Respiratory exchange ratio during an exercise bout with fixed intensity
기간: Mean VCO2/VO2 during a 45 min ergometer cycling bout with fixed intensity
|
Mean VCO2/VO2 during a 45 min ergometer cycling bout with fixed intensity
|
Physical fitness (VO2max)
기간: maximal oxygen consumption (L/min) during a VO2 max test
|
maximal oxygen consumption (L/min) during a VO2 max test
|
기타 결과 측정
결과 측정 |
기간 |
---|---|
AMPK-activation in skeletal muscle during an exercise bout with fixed intensity
기간: change in exercise induced AMPK-activation after compared to before a 45 min ergometer cycling bout with self-selected intensity
|
change in exercise induced AMPK-activation after compared to before a 45 min ergometer cycling bout with self-selected intensity
|
Oxidative phosphorylation in skeletal muscle fibers
기간: Mitochondrial Complex I respiration in skeletal muscle tissue after 17 days of metformin/placebo treatment
|
Mitochondrial Complex I respiration in skeletal muscle tissue after 17 days of metformin/placebo treatment
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Kristian Karstoft, MD, PhD, Center for aktiv sundhed, Rigshospitalet
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 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
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. .
제2형 당뇨병에 대한 임상 시험
-
Postgraduate Institute of Medical Education and...완전한
Metformin에 대한 임상 시험
-
Tan Tock Seng Hospital모병
-
Poznan University of Medical SciencesUniversity of California, San Diego알려지지 않은
-
University Hospital, AntwerpHasselt University; University Hospital, Ghent; AZ Sint-Jan AV; National MS Center Melsbroek; Noorderhart Pelt모병
-
Bing He모집하지 않고 적극적으로
-
Torrent Pharmaceuticals Limited완전한