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Completed

NCT Number: NCT02831621

Exercise and Ectopic Fat Deposition

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.

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Key information

Conditions

Overweight Behavior Body Weight Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Antwerp

Antwerp, Belgium

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

lifestyle intervention (diet OR diet+exercise)

Behavioral

diet or diet+fitness training

Primary outcomes

  1. hepatic lipid content

    Time frame: start - 3 months - 6 months - 12 months

    The hepatic lipid content will also be measured by a 3T MRI scanner (SIEMENS MAGNETOM Prisma, Siemens Healthcare AG, Zürich, Germany). The body coil will be positioned around the chest, as the subjects lay supine. MRI data will be acquired using STEAM, with the parameter setting as follows: 3.0 cm³ voxel in the right liver, TR/TE 3000/20 ms, and no water suppression.

  2. intra myocellular lipids

    Time frame: start - 3 months - 6 months - 12 months

    1H-magnetic resonance spectroscopy (1H-MRs) will be used to quantify lipid levels in the tibialis anterior (slow-twitch) muscle of each subject.The right calf of each subject will be positioned near isocenter surrounded by a body coil within a 3T MRI scanner (SIEMENS MAGNETOM Prisma, Siemens Healthcare AG, Zürich, Germany) following manual shimming on the volume of interest to ensure maximum field homogeneity. The 1H-MRs data will be acquired by a single-voxel Point-Resolved Spectroscopy (PRESS) acquisition. Imaging parameters will be set as follows; repetition time (TR)/echotime (TE) 2000/33 ms, voxel size 15 mm³, and weak water suppression.

  3. pericardial and epicardial fat

    Time frame: start - 3 months - 6 months - 12 months

    Multislice ECG-triggered CT will be used to measure pericardial and epicardial fat areas. All scans will be performed at end-diastole and slice thickness of 2.5 mm. No contrast liquid will be used. Data will be analyzed using the corresponding workstation (GE, AW Volumeshare 2).

  4. visceral fat

    Time frame: start - 3 months - 6 months - 12 months

    A single slice CT of the abdomen will be used to evaluate cross-sectional abdominal visceral adipose tissue areas at the L4-L5 region. The abdominal fat mass and its distribution in visceral adipose tissue (VAT) and subcutaneous adipose tissue (SAT) will be calculated by area measurement on the corresponding CT slice.

  5. antropometric and metabolic parameters

    Time frame: start - (some at) 3 months - 6 months - 12 months

    Every participant will undergo a standard metabolic screening at the beginning of the study. This will include a detailed interview and a clinical examination with anthropometry.

  6. health economic evaluation

    Time frame: start - 3 months - 6 months - 9 months - 12 months

    questionnaires will be used

Sponsors and collaborators

Lead sponsor

Universiteit Antwerpen

Other

Registry information

Official study title

Effect of Diet Plus Exercise Versus Diet Alone on the Reduction of Ectopic Fat Deposition in Adults With Overweight

Acronym: ectofat

Important dates

Study start
2016
Primary completion
2017
Study completion
2019
First posted
Jul 13, 2016
Registry last updated
Jan 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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