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临床试验/NCT04172090
NCT04172090已完成不适用

Short-term Effects of Physical Inactivity on Insulin Sensitivity, Appetite, Energy Balance, and Cardiovascular Responses in Healthy Humans.

University of Nottingham1 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2017年10月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
8
试验地点
1
主要终点
The incremental area under curve for Insulin

研究概览

简要总结

Physical inactivity is a significant predictor of major non-communicable diseases such as type 2 diabetes (7%), cardiovascular disease (6%), musculoskeletal disorders and some cancers, and has been proposed to be the 4th leading cause of death worldwide. Reduced physical activity leads to an impaired function of the hormone insulin and increased adiposity. Thus, the elimination of physical inactivity would remove between 6% and 10% of the major non-communicable diseases and increase life expectancy. The aim of the study is to investigate the effects of a short-term (2-day) period of reduced physical activity, with and without a proportional decrease in energy intake, on the action of insulin to regulate blood sugar fluctuations, appetite, and cardiovascular parameters (heart rate, cardiac output, stroke volume, blood flow, arterial blood pressure, peripheral vascular resistance) in response to food ingestion.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Non-smoking
  • •Males and females
  • •Age (18-35 years old)
  • •Body mass index (BMI) of 18-27 kg/m2
  • •Waist circumference <94cm for males and <80cm for females
  • •Ability to give informed consent

排除标准

  • •Any metabolic (e.g. diabetes), endocrine (e.g. hyperthyroidism) or cardiovascular (e.g. heart or blood) abnormalities including hypertension or heart failure
  • •Clinically significant abnormalities on screening including ECG abnormalities
  • •Taking routine medication that may alter cardiovascular function and blood flow (e.g. blood pressure-lowering drugs or drugs that cause hypertension)
  • •Well trained individuals with PAL>2.00; on an energy-restricted diet or seeking to lose weight
  • •High alcohol consumption (<3-4 units/d for men; <2-3 units/d for women)
  • •Females who are pregnant or lactating; self-reported allergy, intolerance or strong dislike of foods or drinks to be offered for the test breakfast, pasta meal or during the intervention period
  • •Beck Depression Inventory score >10 and Eating Attitudes Test (EAT-26) score >20 as self-reported markers of symptoms and concerns characteristic of depression and eating disorders, respectively.

研究组 & 干预措施

Control

Other

2 consecutive days of standardised daily levels of moderate physical activity (PAL=1.85 reflecting their habitual levels), and matched energy (food) intake

干预措施: Control (Other)

SIT+E

Experimental

2 consecutive days of reduced physical activity induced by prolonged periods of sitting (PAL=1.4) whilst maintaining the level of food intake prescribed in the Control trial, thus creating a positive energy balance

干预措施: SIT+E (Other)

SIT=E

Experimental

2 consecutive days of reduced physical activity induced by prolonged periods of sitting (PAL=1.4) whilst reducing food intake to match the reduction in energy expenditure induced by inactivity, thus maintaining energy balance

干预措施: SIT=E (Other)

结局指标

主要结局

The incremental area under curve for Insulin

时间窗: Over three hours from baseline

The incremental area under curve for Insulin will be calculated using samples collected at 20 minute intervals between baseline and three hours

次要结局

  • The incremental area under curve for arterialized whole blood glucose(Over four hours from baseline)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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