Clinical trial NCT03083587: Frequent Activity Snacks Breaks
Official title: Frequent Activity Snacks Breaks - Interrupting Sedentary Behaviour
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Insulin Resistance
Sedentary Lifestyle
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Baker Heart and Diabetes Institute
name: Australian Catholic University
name: Region Stockholm
First posted: 2017-03-20
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


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

Primary outcomes:
measure: Change in metabolic health including insulin resistance
timeFrame: Change from baseline and 4 week intervention
Secondary outcomes:
measure: Changes at the molecular level in skeletal and fat muscle biopsies
timeFrame: Change from baseline and 4 week intervention
measure: Changes at the molecular level in skeletal and fat muscle biopsies
timeFrame: Change from baseline and 4 week intervention
measure: Changes at the molecular level in skeletal and fat muscle biopsies
timeFrame: Change from baseline and 4 week intervention
measure: Changes in gene expression
timeFrame: Change from baseline and 4 week intervention
measure: Changes in physical activity
timeFrame: Change from baseline and 4 week intervention
measure: Changes in plasma glucose
timeFrame: Change from baseline and 4 week intervention
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Danderyd Hospital
Study officials:
affiliation: Karolinska Institutet
name: Erik Naslund, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.