Frequent Activity Snacks Breaks (FABS)

• ClinicalTrials.gov Identifier: NCT03083587
• Recruitment Status: Completed
• First Posted: March 20, 2017
• Last Update Posted: September 2, 2020
• Sponsor: Karolinska Institutet
• Collaborators: Baker Heart and Diabetes Institute; Australian Catholic University; Region Stockholm
• Information provided by (Responsible Party): Erik Näslund, Karolinska Institutet

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Obesity; Insulin Resistance; Sedentary Lifestyle	Behavioral: Normal lifestyle; Behavioral: Exercise; Procedure: muscle and fat biopsy; Device: Continuous glucose monitoring; Device: Activity monitoring (ActivePal)	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Frequent Activity Snacks Breaks - Interrupting Sedentary Behaviour
• Actual Study Start Date: February 1, 2017
• Actual Primary Completion Date: July 31, 2019
• Actual Study Completion Date: August 30, 2020

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: No intervention; 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.	Behavioral: Normal lifestyle; Normal lifestyle; Procedure: muscle and fat biopsy; Biopsy under local anesthesia; Device: Continuous glucose monitoring; Glucose concentrations during the study period; Device: Activity monitoring (ActivePal); Objective measurements of standing and sitting time
Experimental: Exercise intervention; 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.	Behavioral: Exercise; Mild exercise 3 min every half hour; Procedure: muscle and fat biopsy; Biopsy under local anesthesia; Device: Continuous glucose monitoring; Glucose concentrations during the study period; Device: Activity monitoring (ActivePal); Objective measurements of standing and sitting time

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 60 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

Sweden

Danderyd Hospital

Stockholm, Sweden, 182 88

Sponsors and Collaborators

Karolinska Institutet

Baker Heart and Diabetes Institute

Australian Catholic University

Region Stockholm

Investigators

• Principal Investigator: Erik Naslund, MD, PhD; Karolinska Institutet

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Smith JAB, Savikj M, Sethi P, Platt S, Gabriel BM, Hawley JA, Dunstan D, Krook A, Zierath JR, Näslund E. Three weeks of interrupting sitting lowers fasting glucose and glycemic variability, but not glucose tolerance, in free-living women and men with obesity. Am J Physiol Endocrinol Metab. 2021 Aug 1;321(2):E203-E216. doi: 10.1152/ajpendo.00599.2020. Epub 2021 Jun 21.

• Responsible Party: Erik Näslund, Professor, Karolinska Institutet
• ClinicalTrials.gov Identifier: NCT03083587
• Other Study ID Numbers: 2016/1768
• First Posted: March 20, 2017
• Last Update Posted: September 2, 2020
• Last Verified: September 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases