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Frequent Activity Snacks Breaks (FABS)

Primary Purpose

Obesity, Insulin Resistance, Sedentary Lifestyle

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Normal lifestyle
Exercise
muscle and fat biopsy
Continuous glucose monitoring
Activity monitoring (ActivePal)
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Obesity

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Danderyd Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

No intervention

Exercise intervention

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in metabolic health including insulin resistance
Oral glucose tolerance test including baseline glucose and insulin

Secondary Outcome Measures

Changes at the molecular level in skeletal and fat muscle biopsies
insulin signalling cascade, the pathways that regulate protein synthesis and atrophy, as well as the content and function of mitochondria
Changes at the molecular level in skeletal and fat muscle biopsies
The pathways that regulate protein synthesis and atrophy
Changes at the molecular level in skeletal and fat muscle biopsies
Lipid, protein and metabolites
Changes in gene expression
RNA, mRNA, DNA methylation
Changes in physical activity
Objective measures of standing and sitting
Changes in plasma glucose
Continuous glucose monitoring

Full Information

First Posted
March 3, 2017
Last Updated
September 1, 2020
Sponsor
Karolinska Institutet
Collaborators
Baker Heart and Diabetes Institute, Australian Catholic University, Region Stockholm
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1. Study Identification

Unique Protocol Identification Number
NCT03083587
Brief Title
Frequent Activity Snacks Breaks
Acronym
FABS
Official Title
Frequent Activity Snacks Breaks - Interrupting Sedentary Behaviour
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
February 1, 2017 (Actual)
Primary Completion Date
July 31, 2019 (Actual)
Study Completion Date
August 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
Collaborators
Baker Heart and Diabetes Institute, Australian Catholic University, Region Stockholm

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Insulin Resistance, Sedentary Lifestyle

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
No intervention
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Exercise intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Normal lifestyle
Intervention Description
Normal lifestyle
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Intervention Description
Mild exercise 3 min every half hour
Intervention Type
Procedure
Intervention Name(s)
muscle and fat biopsy
Intervention Description
Biopsy under local anesthesia
Intervention Type
Device
Intervention Name(s)
Continuous glucose monitoring
Intervention Description
Glucose concentrations during the study period
Intervention Type
Device
Intervention Name(s)
Activity monitoring (ActivePal)
Intervention Description
Objective measurements of standing and sitting time
Primary Outcome Measure Information:
Title
Change in metabolic health including insulin resistance
Description
Oral glucose tolerance test including baseline glucose and insulin
Time Frame
Change from baseline and 4 week intervention
Secondary Outcome Measure Information:
Title
Changes at the molecular level in skeletal and fat muscle biopsies
Description
insulin signalling cascade, the pathways that regulate protein synthesis and atrophy, as well as the content and function of mitochondria
Time Frame
Change from baseline and 4 week intervention
Title
Changes at the molecular level in skeletal and fat muscle biopsies
Description
The pathways that regulate protein synthesis and atrophy
Time Frame
Change from baseline and 4 week intervention
Title
Changes at the molecular level in skeletal and fat muscle biopsies
Description
Lipid, protein and metabolites
Time Frame
Change from baseline and 4 week intervention
Title
Changes in gene expression
Description
RNA, mRNA, DNA methylation
Time Frame
Change from baseline and 4 week intervention
Title
Changes in physical activity
Description
Objective measures of standing and sitting
Time Frame
Change from baseline and 4 week intervention
Title
Changes in plasma glucose
Description
Continuous glucose monitoring
Time Frame
Change from baseline and 4 week intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erik Naslund, MD, PhD
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Danderyd Hospital
City
Stockholm
ZIP/Postal Code
182 88
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34151582
Citation
Smith JAB, Savikj M, Sethi P, Platt S, Gabriel BM, Hawley JA, Dunstan D, Krook A, Zierath JR, Naslund 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.
Results Reference
derived

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Frequent Activity Snacks Breaks

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