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Clinical Trials/NCT04172090
NCT04172090
Completed
Not Applicable

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

University of Nottingham1 site in 1 country8 target enrollmentOctober 20, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Sedentary Behavior
Sponsor
University of Nottingham
Enrollment
8
Locations
1
Primary Endpoint
The incremental area under curve for Insulin
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
October 20, 2017
End Date
March 13, 2020
Last Updated
6 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

The incremental area under curve for Insulin

Time Frame: 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

Secondary Outcomes

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

Study Sites (1)

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