ObesityFABSNCT03083587
Frequent Activity Snacks Breaks
A study testing Normal lifestyle, Exercise and muscle and fat biopsy in people with Obesity and Insulin Resistance, run by Karolinska Institutet at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Obesity, Insulin Resistance, Sedentary Lifestyle
- What is being tested?
- Normal lifestyle, Exercise and muscle and fat biopsy
- Type of treatment
- Pill or oral medicine, Medical device, Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSweden
- Study dates
- 1 Feb 2017to 30 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Sedentary lifestyle,
- BMI 30-40 kg/m2
Who cannot join
- Unable to read Swedish (for informed consent),
- anticoagulant therapy,
- unability to perform intervention
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Frequent Activity Snacks Breaks - Interrupting Sedentary Behaviour
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.
- Conditions
- Obesity, Insulin Resistance, Sedentary Lifestyle
- Being tested
- Normal lifestyle, Exercise, muscle and fat biopsy, Continuous glucose monitoring, Activity monitoring (ActivePal)
- Medical subject headings
- Obesity, Insulin Resistance, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normal lifestyleBehavioural
Normal lifestyle
ExerciseBehavioural
Mild exercise 3 min every half hour
muscle and fat biopsyProcedure or surgery
Biopsy under local anesthesia
Continuous glucose monitoringDevice
Glucose concentrations during the study period
Activity monitoring (ActivePal)Device
Objective measurements of standing and sitting time
| Study group | Role | What they receive |
|---|---|---|
| No intervention | Active comparator | 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. Receives: Behavioral: Normal lifestyle; Procedure: muscle and fat biopsy; Device: Continuous glucose monitoring; Device: Activity monitoring (ActivePal) |
| Exercise intervention | Experimental | 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. Receives: Behavioral: Exercise; Procedure: muscle and fat biopsy; Device: Continuous glucose monitoring; Device: Activity monitoring (ActivePal) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in metabolic health including insulin resistance
Oral glucose tolerance test including baseline glucose and insulin
Measured: Change from baseline and 4 week intervention
Secondary outcomes (6)
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
Measured: Change from baseline and 4 week intervention
Changes at the molecular level in skeletal and fat muscle biopsies
The pathways that regulate protein synthesis and atrophy
Measured: Change from baseline and 4 week intervention
Changes at the molecular level in skeletal and fat muscle biopsies
Lipid, protein and metabolites
Measured: Change from baseline and 4 week intervention
Changes in gene expression
RNA, mRNA, DNA methylation
Measured: Change from baseline and 4 week intervention
Changes in physical activity
Objective measures of standing and sitting
Measured: Change from baseline and 4 week intervention
Changes in plasma glucose
Continuous glucose monitoring
Measured: Change from baseline and 4 week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2017
- Study start1 Feb 2017
- Primary completion31 Jul 2019
- Study completion30 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Baker Heart and Diabetes Institute, Australian Catholic University, Region Stockholm
- Responsible party
- Principal investigator, Erik Näslund, Karolinska Institutet
- Investigators
- Erik Naslund, MD, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03083587
- Sponsor's protocol ID
- 2016/1768
- Acronym
- FABS
- Status last verified
- Sep 2020
- First submitted
- 3 Mar 2017
- Last updated
- 2 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34151582
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frequent Activity Snacks Breaks - Interrupting Sedentary Behaviour
- ClinicalTrials.gov ID
- NCT03083587
- Acronym / sponsor ID
- FABS / 2016/1768
- Conditions
- Obesity, Insulin Resistance, Sedentary Lifestyle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Baker Heart and Diabetes Institute, Australian Catholic University, Region Stockholm
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 30 Aug 2020 (actual)
- First posted
- 20 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No intervention | Active comparator | Behavioral: Normal lifestyle, Procedure: muscle and fat biopsy, Device: Continuous glucose monitoring, Device: 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 | Experimental | Behavioral: Exercise, Procedure: muscle and fat biopsy, Device: Continuous glucose monitoring, Device: 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Sedentary lifestyle,
- BMI 30-40 kg/m2
Key exclusion criteria (3 listed)
- Unable to read Swedish (for informed consent),
- anticoagulant therapy,
- unability to perform intervention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Normal lifestyleNormal lifestyle | Behavioural | No intervention |
| ExerciseMild exercise 3 min every half hour | Behavioural | Exercise intervention |
| muscle and fat biopsyBiopsy under local anesthesia | Procedure or surgery | Exercise intervention, No intervention |
| Continuous glucose monitoringGlucose concentrations during the study period | Device | Exercise intervention, No intervention |
| Activity monitoring (ActivePal)Objective measurements of standing and sitting time | Device | Exercise intervention, No intervention |
Primary outcome
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
6 secondary outcomes
Changes at the molecular level in skeletal and fat muscle biopsies
Time frame: Change from baseline and 4 week intervention
Changes at the molecular level in skeletal and fat muscle biopsies
Time frame: Change from baseline and 4 week intervention
Changes at the molecular level in skeletal and fat muscle biopsies
Time frame: Change from baseline and 4 week intervention
Changes in gene expression
Time frame: Change from baseline and 4 week intervention
Changes in physical activity
Time frame: Change from baseline and 4 week intervention
Changes in plasma glucose
Time frame: Change from baseline and 4 week intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2020.
- Derived from this study: PubMed 34151582Smith 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erik Naslund, MD, PhD principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Normal lifestyle, Exercise and muscle and fat biopsy in people with Obesity and Insulin Resistance, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in metabolic health including insulin resistance (time frame: Change from baseline and 4 week intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03083587, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2020.