OverweightectofatNCT02831621
Exercise and Ectopic Fat Deposition
A study testing lifestyle intervention (diet OR diet+exercise) in people with Overweight, run by Universiteit Antwerpen at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Overweight
- What is being tested?
- lifestyle intervention (diet OR diet+exercise)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBelgium
- Study dates
- Jun 2016to Jan 2019
- 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
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Diet Plus Exercise Versus Diet Alone on the Reduction of Ectopic Fat Deposition in Adults With Overweight
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.
Read the detailed description
protocol of the study was published, Hens et al. (physioscience 2017; 13: 80-87)
- Conditions
- Overweight
- Being tested
- lifestyle intervention (diet OR diet+exercise)
- Keywords
- overweight, ectopic fat, exercise, diet
- Medical subject headings
- Overweight, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lifestyle intervention (diet OR diet+exercise)Behavioural
diet or diet+fitness training
| Study group | Role | What they receive |
|---|---|---|
| diet (usual care) | Active comparator | All participants will receive a hypocaloric diet based on the individual resting metabolic rate. Resting metabolic rate (RMR) will be estimated using the WHO formula or measured using indirect calorimetry. Total energy expenditure will be calculated by multiplying RMR with a physical activity level (PAL). The used physical activity level will be 1.3. A hypocaloric diet with an energy deficit of 500 kcal/day will be prescribed. Participants will see a skilled dietician two-weekly the first month and on a monthly basis the next five months to discuss problems and solutions or coping strategies. The first consultation will have a duration of 60 minutes, the next consultations will have a duration of approximately 30 minutes. Each visit, nutritional compliance will be recorded on a 0 to 10 numeric rating scale. The usual care group will be asked to continue with their normal physical activity during the six-month intervention period. Receives: Behavioral: lifestyle intervention (diet OR diet+exercise) |
| diet+exercise | Experimental | For participants of this group, usual care will be supplemented with a prescribed exercise program. For this exercise program the participants will be referred to a local fitness club near home, free of charge. Aerobic training will be done at an intensity of 90-95% of the heart rate achieved at the RCP. Aerobic training will have a duration of 30 to 45 minutes, according to the training stage. Cardio training will be performed on different cardio devices and strength training will be done on isotonic strength training devices. Each training day, core stability training will be completed with four strength exercises for large muscle groups. Each exercise will be done in two sets of 15 repetitions with the goal to achieve better muscular strength endurance.
This combined training will be done individually during six months, three times/week.
In this study, an effort is made to reach a uniform manner of guidance to the physical activity program. Receives: Behavioral: lifestyle intervention (diet OR diet+exercise) |
What is being measured
The primary outcome is the main question the study is designed to answer.
hepatic lipid content
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.
Measured: start - 3 months - 6 months - 12 months
intra myocellular lipids
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.
Measured: start - 3 months - 6 months - 12 months
pericardial and epicardial fat
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).
Measured: start - 3 months - 6 months - 12 months
visceral fat
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.
Measured: start - 3 months - 6 months - 12 months
antropometric and metabolic parameters
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.
Measured: start - (some at) 3 months - 6 months - 12 months
health economic evaluation
questionnaires will be used
Measured: start - 3 months - 6 months - 9 months - 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2016 (estimated)
- Study startJun 2016
- Primary completionAug 2017
- Study completionJan 2019
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 OverweightStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiteit Antwerpen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wendy Hens, Universiteit Antwerpen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02831621
- Sponsor's protocol ID
- 14/17/205
- Acronym
- ectofat
- Status last verified
- Jan 2019
- First submitted
- 8 Jul 2016
- Last updated
- 25 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 30069308
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Diet Plus Exercise Versus Diet Alone on the Reduction of Ectopic Fat Deposition in Adults With Overweight
- ClinicalTrials.gov ID
- NCT02831621
- Acronym / sponsor ID
- ectofat / 14/17/205
- Conditions
- Overweight
- Keywords
- overweight, ectopic fat, exercise, diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Universiteit AntwerpenUniversity, hospital or other
- Study start
- Jun 2016 (actual)
- Primary completion
- Aug 2017 (actual)
- Study completion
- Jan 2019 (actual)
- First posted
- 13 Jul 2016 (estimated)
- 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.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| diet (usual care) | Active comparator | Behavioral: lifestyle intervention (diet OR diet+exercise)All participants will receive a hypocaloric diet based on the individual resting metabolic rate. Resting metabolic rate (RMR) will be estimated using the WHO formula or measured using indirect calorimetry. Total energy expenditure will be calculated by multiplying RMR with a physical activity level (PAL). The used physical activity level will be 1.3. A hypocaloric diet with an energy deficit of 500 kcal/day will be prescribed. Participants will see a skilled dietician two-weekly the first month and on a monthly basis the next five months to discuss problems and solutions or coping strategies. The first consultation will have a duration of 60 minutes, the next consultations will have a duration of approximately 30 minutes. Each visit, nutritional compliance will be recorded on a 0 to 10 numeric rating scale. The usual care group will be asked to continue with their normal physical activity during the six-month intervention period. |
| diet+exercise | Experimental | Behavioral: lifestyle intervention (diet OR diet+exercise)For participants of this group, usual care will be supplemented with a prescribed exercise program. For this exercise program the participants will be referred to a local fitness club near home, free of charge. Aerobic training will be done at an intensity of 90-95% of the heart rate achieved at the RCP. Aerobic training will have a duration of 30 to 45 minutes, according to the training stage. Cardio training will be performed on different cardio devices and strength training will be done on isotonic strength training devices. Each training day, core stability training will be completed with four strength exercises for large muscle groups. Each exercise will be done in two sets of 15 repetitions with the goal to achieve better muscular strength endurance. This combined training will be done individually during six months, three times/week. In this study, an effort is made to reach a uniform manner of guidance to the physical activity program. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
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 |
|---|---|---|
| lifestyle intervention (diet OR diet+exercise)diet or diet+fitness training | Behavioural | diet (usual care), diet+exercise |
Primary outcome
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.
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.
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).
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.
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.
health economic evaluation
Time frame: start - 3 months - 6 months - 9 months - 12 months
questionnaires will be used
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 25 Jan 2019.
- Derived from this study: PubMed 30069308Hens 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.
Related trials for Overweight
RecruitingObservational study
Early Tracking of Childhood Health Determinants (ETCHED) Study
Diabetes Mellitus, Obesity
Active, not recruiting
Effect of the Thrive AI Health App on Lifestyle Behaviors and Quality of Life
Diabetes Type 2, Overweight or Obesity
Not yet recruitingPhase 3
SYNCHRONIZE®-START- A Study to Test Whether Survodutide Helps People Living With Overweight or Obesity Who do Not Have Diabetes to Lose Weight
Obesity
Not yet recruitingObservational study
Assessing the Impact of Perceptions of Unpredictability on Objective Measures of Food Consumption and Metabolism
Healthy Volunteer, Obestity
Not yet recruitingPhase 1/2
Investigating the Effects of 24 Hour LEAP2 Infusion in Individuals With Overweight and Obesity
Obesity & Overweight
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lifestyle intervention (diet OR diet+exercise) in people with Overweight, run by Universiteit Antwerpen at 1 site in Belgium.
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 9 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 25 Jan 2019. 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 Belgium. 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?
hepatic lipid content (time frame: start - 3 months - 6 months - 12 months). The study lists 6 primary outcomes in all. 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 NCT02831621, 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 25 Jan 2019.