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

NCT04172090 | Completed

• 1 other identifier: I200317
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Sedentary Behavior

Outcome Measures

Primary Outcomes (1)

• The incremental area under curve for Insulin

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

  Over three hours from baseline

Secondary Outcomes (1)

• The incremental area under curve for arterialized whole blood glucose

  Over four hours from baseline

Other Outcomes (7)

• The incremental area under curve for free fatty acids

  Over three hours from baseline

• The incremental area under curve for Triglycerides

  Over three hours from baseline

• The incremental area under curve for Ghrelin

  Over four hours from baseline

Study Arms (3)

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

Other: Control

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

Other: SIT+E

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

Other: SIT=E

Interventions

Control OTHER

Normal physical activity and standard energy intake

Control

SIT=E OTHER

Reduced physical activity and reduced energy intake

SIT=E

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Smoking
• 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.

Sponsors & Collaborators

• University of Nottingham: lead

Study Sites (1)

University of Nottingham

Nottingham, United Kingdom

Location

MeSH Terms

Conditions

Sedentary Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2019
• First Posted: November 21, 2019
• Study Start: October 20, 2017
• Primary Completion: March 13, 2020
• Study Completion: March 13, 2020
• Last Updated: March 30, 2020

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)