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Completed

NCT Number: NCT03912922

SIT LESS 4: How Does Reducing Sitting Time Improve Glucose and Lipid Metabolism?

Research has shown that replacing sitting time with low intensity physical activity (such as slowly walking and standing) has beneficial effects on metabolic health, like insulin sensitivity, comparable to improvements after sitting all day in combination with 1h streneous exercise.

The main objective of this study is to investigate the underlying mechanisms responsible for improved insulin sensitivity after 4 days of sitting less compared to sitting and exercise in healthy obese women. Our secondary objective is to investigate the effects of sitting less on cardio metabolic parameters.

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Key information

Conditions

Overweight and Obesity Body Weight Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

45 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Maastricht University Medical Centre

Maastricht, Netherlands

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Signed informed consent
  • Caucasian
  • Postmenopausal women
  • Aged 45-70 years at start of the study
  • Body mass index (BMI) 25 - 35 kg/m2
  • Stable dietary habits (no weight loss or gain >5kg in the past 3 months)
  • Sedentary lifestyle (not more than 2,5 hours of exercise per week in the past 3 months)

Exclusion criteria

  • Not able to complete the sitless try-out day according to the protocol
  • Active diseases (cardiovascular, diabetes, liver, kidney, cancer or other)
  • No use of medication interfering with investigated study parameters (as determined by responsible physician)
  • Alcohol consumption of >2 servings per day
  • Smoking in the past 6 months
  • Participation in another biomedical trial which may have an effect on insulin sensitivity less than one month before the start of the study (screening visit)
  • Mental or physical disability which interferes with physical activity
  • Subjects with contra-indications for magnetic resonance imaging (MRI)
  • Reported participation in night shift work 2 weeks prior to the start of the study (screening visit) and during study participation. Night work is defined as working between midnight and 6.00 AM.

Treatment and study plan

Activity regime

Other

Activity regime of 4 days followed by a test day.

Primary outcomes

  1. Insulin sensitivity

    Time frame: Day 5 of intervention period

    2-step hyperinsulinemic euglycemic clamp

Secondary outcomes

  1. ex vivo skeletal muscle mitochondrial respiration

    Time frame: Day 5 of intervention period

    oxygraph

  2. substrate oxidation

    Time frame: Day 5 of intervention period

    indirect calorimetry RER

  3. Intrahepatic lipid content

    Time frame: Day 5 of intervention period

    magnetic resonance spectroscopy

  4. Blood pressure

    Time frame: Day 5 of intervention period

    average resting blood pressure over 30 minutes

  5. Plasma cardio metabolic markers

    Time frame: Day 5 of intervention period

    endothelial dysfunction score (average Z-score of log transformed plasma sVCAM1, sICAM1 and sE-selectin)

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Collaborators

  • Dutch Heart Foundation

Registry information

Official study title

SIT LESS 4: How Does Reducing Sitting Time Improve Glucose and Lipid Metabolism? A Study to Identify Underlying Mechanisms

Acronym: SITLESS4

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Apr 11, 2019
Registry last updated
Jan 20, 2021

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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