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Completed

NCT Number: NCT04172090

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

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.

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Key information

Conditions

Sedentary Behavior Behavior

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Nottingham

Nottingham, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

Control

Other

Normal physical activity and standard energy intake

SIT+E

Other

Reduced physical activity and standard energy intake

SIT=E

Other

Reduced physical activity and reduced energy intake

Primary outcomes

  1. 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

  1. The incremental area under curve for arterialized whole blood glucose

    Time frame: Over four hours from baseline

    The incremental area under curve for arterialized whole blood glucose will be calculated using samples collected at 10 minute intervals between baseline and four hours

Other outcomes

  1. The incremental area under curve for free fatty acids

    Time frame: Over three hours from baseline

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

  2. The incremental area under curve for Triglycerides

    Time frame: Over three hours from baseline

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

  3. The incremental area under curve for Ghrelin

    Time frame: Over four hours from baseline

    The incremental area under curve for Ghrelin will be calculated using samples collected at one hour intervals between baseline and four hours

  4. The incremental area under curve for composite satiety score

    Time frame: Over four hours from baseline

    Composite satiety score will be calculated using 100mm visual analogue score ratings of satiety, fullness, hunger, desire to eat and prospective food consumption collected every 20 minutes between baseline and four hours.

  5. Weight of consumption of a pasta meal three hours after baseline

    Time frame: Three hours post baseline

    Weight of pasta consumed from a bowel refilled prior to being empty until participants feel comfortably full

  6. The incremental area under curve for cardiovascular parameters

    Time frame: Over three hours from baseline

    The incremental area under curve for mean blood pressure,cardiac output, stroke volume, peripheral resistance, heart rate, systolic blood pressure and diastolic blood pressure continuously over three hours from baseline using Finometer

  7. The incremental area under curve for limb blood flow

    Time frame: Over three hours from baseline

    The incremental area under curve for limb blood flow measured at 30 minute intervals between baseline and three hours using venous occlusion plethysmography

Sponsors and collaborators

Lead sponsor

University of Nottingham

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Nov 21, 2019
Registry last updated
Mar 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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