Frequent Activity Snacks Breaks

Not Applicable

Completed

• Conditions: Obesity; Sedentary Lifestyle; Insulin Resistance
• Interventions: Behavioral: Normal lifestyle; Behavioral: Exercise; Procedure: muscle and fat biopsy; Device: Continuous glucose monitoring; Device: Activity monitoring (ActivePal)

• Registration Number: NCT03083587
• Lead Sponsor: Karolinska Institutet

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-02-01
• Study First Submitted: 2017-03-03
• Study First Submitted QC: 2017-03-13
• Study First Posted: 2017-03-20
• Primary Completion: 2019-07-31
• Study Completion: 2020-08-30
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-01
• Last Update Posted: 2020-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
No intervention	muscle and fat biopsy	Normal lifestyle. Subjects will undergo a muscle and fat biopsy at the start of the 4 w period and after. An oral glucose test at the start and after completion of the 4 week period. Physical activity and glucose will be monitored during the study period.
No intervention	Continuous glucose monitoring	Normal lifestyle. Subjects will undergo a muscle and fat biopsy at the start of the 4 w period and after. An oral glucose test at the start and after completion of the 4 week period. Physical activity and glucose will be monitored during the study period.
No intervention	Normal lifestyle	Normal lifestyle. Subjects will undergo a muscle and fat biopsy at the start of the 4 w period and after. An oral glucose test at the start and after completion of the 4 week period. Physical activity and glucose will be monitored during the study period.
Exercise intervention	Exercise	Followed by a 1 week normal run in period subjects will undergo a 3 min bout, every half hour between 8 am and 6 pm comprises of simple low-intensity exercise such as moderate walking about or climbing a flight of stairs over a 3-week period. Subjects will undergo a muscle and fat biopsy at the start of the 4 w period and after. An oral glucose test at the start and after completion of the 4 week period. Physical activity and glucose will be monitored during the study period.
No intervention	Activity monitoring (ActivePal)	Normal lifestyle. Subjects will undergo a muscle and fat biopsy at the start of the 4 w period and after. An oral glucose test at the start and after completion of the 4 week period. Physical activity and glucose will be monitored during the study period.
Exercise intervention	muscle and fat biopsy	Followed by a 1 week normal run in period subjects will undergo a 3 min bout, every half hour between 8 am and 6 pm comprises of simple low-intensity exercise such as moderate walking about or climbing a flight of stairs over a 3-week period. Subjects will undergo a muscle and fat biopsy at the start of the 4 w period and after. An oral glucose test at the start and after completion of the 4 week period. Physical activity and glucose will be monitored during the study period.
Exercise intervention	Continuous glucose monitoring	Followed by a 1 week normal run in period subjects will undergo a 3 min bout, every half hour between 8 am and 6 pm comprises of simple low-intensity exercise such as moderate walking about or climbing a flight of stairs over a 3-week period. Subjects will undergo a muscle and fat biopsy at the start of the 4 w period and after. An oral glucose test at the start and after completion of the 4 week period. Physical activity and glucose will be monitored during the study period.
Exercise intervention	Activity monitoring (ActivePal)	Followed by a 1 week normal run in period subjects will undergo a 3 min bout, every half hour between 8 am and 6 pm comprises of simple low-intensity exercise such as moderate walking about or climbing a flight of stairs over a 3-week period. Subjects will undergo a muscle and fat biopsy at the start of the 4 w period and after. An oral glucose test at the start and after completion of the 4 week period. Physical activity and glucose will be monitored during the study period.

Primary Outcome Measures

Name	Time	Method
Change in metabolic health including insulin resistance	Change from baseline and 4 week intervention	Oral glucose tolerance test including baseline glucose and insulin

Secondary Outcome Measures

Name	Time	Method
Changes in gene expression	Change from baseline and 4 week intervention	RNA, mRNA, DNA methylation
Changes in physical activity	Change from baseline and 4 week intervention	Objective measures of standing and sitting
Changes at the molecular level in skeletal and fat muscle biopsies	Change from baseline and 4 week intervention	Lipid, protein and metabolites
Changes in plasma glucose	Change from baseline and 4 week intervention	Continuous glucose monitoring

Trial Locations

Locations (1)

Danderyd Hospital; 🇸🇪 Stockholm, Sweden