Frequent Activity Snacks Breaks (FABS)

Karolinska Institute

Status: Completed

Conditions: Insulin Resistance; Obesity; Sedentary Lifestyle

Treatments: Procedure: muscle and fat biopsy; Behavioral: Normal lifestyle; Device: Continuous glucose monitoring; Device: Activity monitoring (ActivePal); Behavioral: Exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT03083587

2016/1768

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

No intervention

Active Comparator group

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.

Treatment:

Device: Activity monitoring (ActivePal)

Behavioral: Normal lifestyle

Procedure: muscle and fat biopsy

Device: Continuous glucose monitoring

Exercise intervention

Experimental group

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.

Treatment:

Device: Activity monitoring (ActivePal)

Procedure: muscle and fat biopsy

Behavioral: Exercise

Device: Continuous glucose monitoring