Clinical trial NCT02831621: Exercise and Ectopic Fat Deposition
Official title: Effect of Diet Plus Exercise Versus Diet Alone on the Reduction of Ectopic Fat Deposition in Adults With Overweight
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Keywords: overweight
ectopic fat
exercise
diet
Lead sponsor: Universiteit Antwerpen
Sponsor class: OTHER
First posted: 2016-07-13
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Excess ectopic fat deposition is associated with development of cardiovascular and metabolic diseases. This study investigates how lifestyle interventions can have an effect on different sites of ectopic fat deposition and cardiovascular or metabolic factors. Moreover, the clinical and economic value of exercise to supplement a hypocaloric diet is investigated.

Endocrinologists of the University Hospital of Antwerp, Belgium, will be recruiting women during consultations. Also, recruitment posters will be used in the University Hospital of Antwerp and the University of Antwerp. Potential participants meeting all a priori set inclusion and exclusion criteria will be randomized by minimization method to a hypocaloric diet group (usual care) or a group of hypocaloric diet combined with physical fitness training. Both groups will undergo an intake procedure in which personal goals are set and barriers to changes in behavior will be discussed. Ectopic fat deposition will be measured by imaging techniques after three and six months of intervention. Based on the known relationship between ectopic fat and cardiovascular outcomes, the short term study results will then be extrapolated to an estimation of the reduction of cardiovascular events.

The following clinical outcomes will be presented: change in ectopic fat in the abdomen (visceral fat), the liver (intra hepatic lipids), skeletal muscle (intra myocellular lipids), heart (epicardial fat) after a dietary or combined (diet+physical activity) intervention. The impact of supervised exercise in addition to diet will be expressed in projected healthcare costs and quality adjusted life years.

Detailed description: protocol of the study was published, Hens et al. (physioscience 2017; 13: 80-87)

Eligibility criteria: Inclusion Criteria:

* Participants should be willing to undergo a weight loss intervention and body weight must be stable during the past six months.
* There will be no upper eligibility criterion for body mass index (BMI) but BMI should be at least 27 kg/m².

Exclusion Criteria:

* Individuals who have a clinical history of type 2 diabetes, prediabetes (with use of medication), or hypothyroidism will be excluded.
* when postmenopausal; Premenopausal state will be verified by hormonal data (follicle-stimulation hormone (FSH) \< 25 mU/ml and estradiol \> 20 pg/ml).
* Subjects will not be allowed when pregnancy is planned
* when physical activity is not possible due to problems of the musculoskeletal system
* when changes in medication (e.g. beta blockers) are advised by an endocrinologist.
* when smoking
* when drinking more than two alcoholic consumptions/day or binge drinking (self-reported)
* when taking medication that influences body weight or metabolism (e.g. tricyclic antidepressants)
* Since all participants will undergo medical imaging, exclusion criteria related to MRI and CT scans are also applicable.

Primary outcomes:
measure: hepatic lipid content
timeFrame: start - 3 months - 6 months - 12 months
measure: intra myocellular lipids
timeFrame: start - 3 months - 6 months - 12 months
measure: pericardial and epicardial fat
timeFrame: start - 3 months - 6 months - 12 months
measure: visceral fat
timeFrame: start - 3 months - 6 months - 12 months
measure: antropometric and metabolic parameters
timeFrame: start - (some at) 3 months - 6 months - 12 months
measure: health economic evaluation
timeFrame: start - 3 months - 6 months - 9 months - 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Antwerp
country: Belgium
facility: University Hospital of Antwerp
Study officials:
References:
citation: Hens W, Vissers D, Annemans L, Gielen J, Van Gaal L, Taeymans J, Verhaeghe N. Health-related costs in a sample of premenopausal non-diabetic overweight or obese females in Antwerp region: a cost-of-illness analysis. Arch Public Health. 2018 Jul 30;76:42. doi: 10.1186/s13690-018-0285-1. eCollection 2018.