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Frequent Activity Snacks Breaks (FABS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03083587
Recruitment Status : Completed
First Posted : March 20, 2017
Last Update Posted : September 2, 2020
Sponsor:
Collaborators:
Baker Heart and Diabetes Institute
Australian Catholic University
Region Stockholm
Information provided by (Responsible Party):
Erik Näslund, 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.

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

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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

Resource links provided by the National Library of Medicine


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




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



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03083587


Locations
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Sweden
Danderyd Hospital
Stockholm, Sweden, 182 88
Sponsors and Collaborators
Karolinska Institutet
Baker Heart and Diabetes Institute
Australian Catholic University
Region Stockholm
Investigators
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Principal Investigator: Erik Naslund, MD, PhD Karolinska Institutet
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Erik Näslund, Professor, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT03083587    
Other Study ID Numbers: 2016/1768
First Posted: March 20, 2017    Key Record Dates
Last Update Posted: September 2, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases