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Completed

NCT Number: NCT03083587

Frequent Activity Snacks Breaks

There is a growing health burden in Sweden and Europe arising from the interrelated sequelae of metabolic disorders comprising impaired glucose tolerance (IGT), obesity and T2DM. Obesity and inactivity are the main drivers of IGT and T2DM and are responsible for up to 8% of health costs and 13% of deaths in Europe, with the risk of co-morbidities rising in parallel with increasing body weight. IGT and T2DM are the paradigm of inactivity-related disorders: the majority of people who have IGT or T2DM are overweight and inactive, with up to 80% being obese. A recent meta-analysis of 42 studies concluded that sedentary time was independently associated with a greater risk of T2D, all-cause mortality, cardiovascular disease incidence and mortality, and cancer incidence and mortality (breast, colon, colorectal, endometrial and epithelial ovarian cancers) (Ann Intern Med. 2015;162:123-32). A recent systematic review of trials published up to April 2014 identified 16 separate studies and concluded that there is considerable evidence of the positive effects of breaking up prolonged sitting time with light-intensity ambulatory physical activity and standing on postprandial metabolic parameters, including glucose, insulin and triglyceride levels (Med Sci Sports Exerc. 2015:47:2053-61). However, to date, all of the published experimental trials describing the beneficial effects of breaking up sitting time on metabolic risk markers have been restricted to acute exposure periods (1-5 days). We will perform a RCT intervention study, which examines the efficacy (clinically relevant responses) and practical implementation of low-impact training in sedentary obese individuals during the day.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Danderyd Hospital

Stockholm, 182 88, Sweden

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Sedentary lifestyle,
  • BMI 30-40 kg/m2

Exclusion criteria

  • Unable to read Swedish (for informed consent),
  • anticoagulant therapy,
  • unability to perform intervention

Treatment and study plan

Normal lifestyle

Behavioral

Normal lifestyle

Exercise

Behavioral

Mild exercise 3 min every half hour

muscle and fat biopsy

Procedure

Biopsy under local anesthesia

Continuous glucose monitoring

Device

Glucose concentrations during the study period

Activity monitoring (ActivePal)

Device

Objective measurements of standing and sitting time

Primary outcomes

  1. Change in metabolic health including insulin resistance

    Time frame: Change from baseline and 4 week intervention

    Oral glucose tolerance test including baseline glucose and insulin

Secondary outcomes

  1. Changes at the molecular level in skeletal and fat muscle biopsies

    Time frame: Change from baseline and 4 week intervention

    insulin signalling cascade, the pathways that regulate protein synthesis and atrophy, as well as the content and function of mitochondria

  2. Changes at the molecular level in skeletal and fat muscle biopsies

    Time frame: Change from baseline and 4 week intervention

    The pathways that regulate protein synthesis and atrophy

  3. Changes at the molecular level in skeletal and fat muscle biopsies

    Time frame: Change from baseline and 4 week intervention

    Lipid, protein and metabolites

  4. Changes in gene expression

    Time frame: Change from baseline and 4 week intervention

    RNA, mRNA, DNA methylation

  5. Changes in physical activity

    Time frame: Change from baseline and 4 week intervention

    Objective measures of standing and sitting

  6. Changes in plasma glucose

    Time frame: Change from baseline and 4 week intervention

    Continuous glucose monitoring

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • Australian Catholic University
  • Baker Heart and Diabetes Institute
  • Region Stockholm

Registry information

Official study title

Frequent Activity Snacks Breaks - Interrupting Sedentary Behaviour

Acronym: FABS

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Mar 20, 2017
Registry last updated
Sep 2, 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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