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SIT LESS 3: The Effect of Low Intensity Physical Activity on Insulin Sensitivity, Mood and Cognitive Performance (SIT LESS 3)

2016년 3월 15일 업데이트: Maastricht University Medical Center

Background of the study:

A sedentary lifestyle and obesity are well known risk factors of type 2 diabetes. The major focus of current guidelines for type 2 diabetes prevention is on energy balance. Physical activity guidelines recommend at least 30 minutes/day of moderate to vigorous physical activity (MVPA). However, no advice is given how the other 23.5 hours of the day should be spent. Several recent epidemiologic studies suggest that excessive sitting, independent of moderate to vigorous physical activity, has detrimental health effects. Another possibility to sit less is by increasing low intensity physical activities as slowly walking and standing. A recent published study of Duvivier and colleagues suggests that sitting less and replacing it by slowly walking and standing has a better effect on insulin action and cardiovascular risk factors than the combination of one hour MVPA per day and sitting the rest of the day in healthy subjects (Duvivier et al. PLOS ONE 2013). Until now this research is not performed in subjects with overweight/obesity.

Objective of the study:

To assess the effect of low intensity physical activity on plasma insulin levels, cognition and mood in subjects with overweight/obesity

Study population:

21 subjects between 40-80 years old with overweight/obesity

Intervention:

2 activity regimes of 4 days: a sitting regime and a "sit less" regime

연구 개요

상태

완전한

연구 유형

중재적

등록 (실제)

24

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

      • Maastricht, 네덜란드, 6200MD
        • Human Movement Science, Maastricht University

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

40년 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

  • Signed informed consent
  • Men and postmenopausal women: 40-80 years old
  • BMI: 25.0 - 35.0 kg/m2
  • Maximum 2.5 hours of MVPA per week (during last 3 months)
  • Having a general practitioner
  • Agreeing to be informed about medically relevant personal test-results by a physician
  • Accessible veins on arms as determined by examination at screening

Exclusion Criteria:

  • Reported participation in another biomedical trial which may have an effect on insulin sensitivity one month before the pre-study examination or during the study
  • Blood donation in the past three months
  • Reported participation in night shift work 2 weeks prior to pre-study investigation or during the study. Night work is defined as working between midnight and 6.00 AM.
  • Consumption of >14 (women) or > 21 (men) alcoholic units per week
  • Reported dietary habits: medically prescribed diet, slimming diet;
  • Reported weight loss (>2kg) in the last three months prior to the screening;
  • Not being able to execute at least three (out of four) cognition tests in the training session
  • Not being able to execute the sit less try-out day
  • Being an employee of Unilever or the collaborating research departments in Maastricht University Medical Centre
  • Experimental drug use (during the last 3 months)
  • Use of insulin, oral blood glucose lowering medication (metformin and/or SU-derivatives and/or DPP-IV inhibitors), corticosteroids or vitamin K antagonists in the last 3 months
  • Fasting plasma glucose level > 6.9 mmol/L
  • Medical conditions which make participation in the study not responsible which will be decided by a medical doctor during screening
  • Other clinically relevant abnormalities in clinical chemistry at screening (to be judged by a medical doctor)
  • Mental or physical disability which interferes with physical activity

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 방지
  • 할당: 무작위
  • 중재 모델: 크로스오버 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Sitting regime
The subjects will follow the sitting regime during four days. Each day: 14 hours sitting, 1 hour walking and 1 hour standing and 8 hours sleeping.
Information already included in arm descriptions
실험적: Sit Less regime
Subjects will follow the sit less regime during four days. Each day will consist of 9 hours sitting, 4 hours walking, 3 hours standing and 8 hours sleeping. The walking and standing will be done in a minimum of eight bouts with a time interval of >1 hour. The subjects will be instructed to walk on a slow pace, i.e. 2-3 km/h, which is comparable to walking during shopping, walking to the office etc.
Information already included in arm descriptions

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Plasma insulin levels (measured as area under the curve during an oral glucose tolerance test)
기간: one day after each regime
To assess the effect of low intensity physical activity (LIPA) on plasma insulin levels (as measured as area under the curve during an oral glucose tolerance test)
one day after each regime

2차 결과 측정

결과 측정
측정값 설명
기간
Insulin sensitivity (measured as Matsuda combined insulin sensitivity index during an oral glucose tolerance test)
기간: one day after each regime
To assess the effect of LIPA on insulin sensitivity
one day after each regime
Plasma C-peptide
기간: one day after each regime
To assess the effect of LIPA on plasma C-peptide
one day after each regime
Plasma glucose levels
기간: one day after each regime
To assess the effect of LIPA on plasma glucose levels
one day after each regime
Plasma triglycerides
기간: one day after each regime
To assess the effect of LIPA on plasma triglycerides
one day after each regime
Plasma total cholesterol
기간: one day after each regime
To assess the effect of LIPA on plasma total cholesterol
one day after each regime
Plasma non-HDL cholesterol
기간: one day after each regime
To assess the effect of LIPA on plasma non-HDL cholesterol
one day after each regime
Plasma HDL cholesterol
기간: one day after each regime
To assess the effect of LIPA on plasma HDL cholesterol
one day after each regime
Plasma LDL cholesterol
기간: one day after each regime
To assess the effect of LIPA on plasma LDL cholesterol
one day after each regime
Plasma free fatty acids
기간: one day after each regime
To assess the effect of LIPA on plasma free fatty acids
one day after each regime
Plasma apolipoprotein B
기간: one day after each regime
To assess the effect of LIPA on plasma apolipoprotein B
one day after each regime
Plasma apolipoprotein A
기간: one day after each regime
To assess the effect of LIPA on plasma apolipoprotein A
one day after each regime
Mood (measured by the Affect Grid mood scale)
기간: 2 days: last day of each regime and one day after each regime
To assess the effect of LIPA on mood
2 days: last day of each regime and one day after each regime
Attention (measured by the Attention Network Task)
기간: one day after each regime before and after the oral glucose tolerance test
To assess the effect of LIPA on attention
one day after each regime before and after the oral glucose tolerance test
Executive Function (measured by the Trail Making Test)
기간: one day after each regime before and after the oral glucose tolerance test
To assess the effect of LIPA on executive function
one day after each regime before and after the oral glucose tolerance test
Memory (measured by the Rey Auditory Verbal Learning Task)
기간: one day after each regime before and after the oral glucose tolerance test
To assess the effect of LIPA on memory
one day after each regime before and after the oral glucose tolerance test
Quality of life (measured by the Gill 32-item questionnaire)
기간: last day of each regime
To assess the effect of LIPA on quality of life
last day of each regime
Sleep (measured by the 10-item Pittsburgh Sleep Quality Index)
기간: last day of each regime
To assess the effect of LIPA on sleep
last day of each regime
Plasma C-reactive protein
기간: one day after each regime
To assess the effect of LIPA on plasma C-reactive protein
one day after each regime
Plasma interleukin 1
기간: one day after each regime
To assess the effect of LIPA on plasma interleukin 1
one day after each regime
Plasma interleukin 6
기간: one day after each regime
To assess the effect of LIPA on plasma interleukin 6
one day after each regime
Plasma TNF-alpha
기간: one day after each regime
To assess the effect of LIPA on plasma TNF-alpha
one day after each regime
Plasma interferon gamma
기간: one day after each regime
To assess the effect of LIPA on plasma interferon gamma
one day after each regime
Plasma ICAM-1
기간: one day after each regime
To assess the effect of LIPA on plasma ICAM-1
one day after each regime
Plasma VCAM
기간: one day after each regime
To assess the effect of LIPA on plasma VCAM
one day after each regime
Plasma serum amyloid A (SAA)
기간: one day after each regime
To assess the effect of LIPA on plasma SAA
one day after each regime
Plasma E-selectine
기간: one day after each regime
To assess the effect of LIPA on plasma E-selectine
one day after each regime
Plasma von Willebrand factor (vWF)
기간: one day after each regime
To assess the effect of LIPA on plasma vWF
one day after each regime
Plasma PAI-1
기간: one day after each regime
To assess the effect of LIPA on plasma PAI-1
one day after each regime
To explore the association between plasma glucose, plasma insulin, insulin sensitivity and mood, cognitive performance, quality of life and sleep
기간: one day after each regime
one day after each regime
Blood pressure
기간: one day after each regime
one day after each regime
Heart rate
기간: one day after each regime
one day after each regime

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

협력자

수사관

  • 수석 연구원: Hans H Savelberg, PhD, Maastricht University Hospital

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

유용한 링크

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2015년 2월 1일

기본 완료 (실제)

2015년 9월 1일

연구 완료 (실제)

2015년 9월 1일

연구 등록 날짜

최초 제출

2015년 2월 19일

QC 기준을 충족하는 최초 제출

2015년 3월 16일

처음 게시됨 (추정)

2015년 3월 20일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2016년 3월 16일

QC 기준을 충족하는 마지막 업데이트 제출

2016년 3월 15일

마지막으로 확인됨

2016년 3월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • 143046
  • NL50688.068.14 (레지스트리 식별자: Medical Ethical Committee Maastricht University Hospital / University of Maastricht)

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. .

Physical activity regime에 대한 임상 시험

3
구독하다