Metabolic SyndromeNCT00917917
Effect of Physical Activity and Diet on the Treatment of Metabolic Syndrome
A study testing Type of physical activity (resistance, endurance) and Restrictive diet in people with Metabolic Syndrome, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
Metabolic syndrome has been defined as a group of associated risk factors for cardio-vascular diseases and diabetes. It is usually treated with an association of restrictive diet, physical exercise and drugs. Nevertheless the type of exercise associated to reduction in cardio-vascular risks is not yet fully defined. Read more about this study
- Who is it for?
- Ages 50 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- Type of physical activity (resistance, endurance) and Restrictive diet
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- May 2009to Oct 2011
- 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 50 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 50-70 years old from both sexes
- with metabolic syndrome
- affiliated to a social security system
- able to practice maximal physical exercises based on VO2 max
- able to sign inform consent
Who cannot join
- recent (6 month) major health conditions and patients with recurrent health problems (1 per year)
- patients who are not capable to perform VO2 max without abnormalities
- dyserection treated patients
- patients with insufficient comprehensive ability to feel questionnaire and/or to change habits
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Role of Combined Intervention of Physical Activity and Nutrition in Metabolic Syndrome Treatment on Cardio-vascular Risk and Muscular- Skeletal Functions in Human Subject. Analysis of Patient's Compliance in Patient's Follow-up.
Metabolic syndrome has been defined as a group of associated risk factors for cardio-vascular diseases and diabetes. It is usually treated with an association of restrictive diet, physical exercise and drugs. Nevertheless the type of exercise associated to reduction in cardio-vascular risks is not yet fully defined. Long term effects of such hygienic-diet programs are of great importance since it is well-known that compliance to such treatment are of short duration, namely when subjects return in routine life. Metabolic syndrome volunteer subjects (n=90), aged 50 to 70 yrs will be randomly assigned to 3 groups of investigation.One group will perform mostly resistance activity, a second mainly endurance activity and the third one will be composed of subjects not exercising a lot. All subjects will have the same restrictive diet (500-700 kcal/d) After the initial training (3 weeks), they will return home with diet and physical program advises (personal compliance). They will be followed for one year (at 3, 6 and 12 months) Such a design may allow to find out the type of activity and power that are the best to reduce metabolic syndrome parameters and cardio-vascular risk factors.
The primary outcome variable is the reduction in abdominal circumference, which is the main criteria of MS.
Read the detailed description
The protocol is designed to determine which type of physical activity is the best to reduce metabolic syndrome parameters especially abdominal circumference.
90 Metabolic syndrome (MS) Patients will be recruited by advertising and checked for MS criteria. They will have a VO2max test in order to be sure they can perform physical activities safely. After being checked, patients will have an eight day period to think about participation and to ask questions before signing consent. They have to feel 3 questionnaires, one about regular physical activities, one about food intakes and a psychology one to measure reluctance to the program. After written informed consent obtained, patients will be randomly assigned to one of 3 groups of physical activity Group 1 will perform mostly resistance activities, group 2 mostly endurance activities, and group 3 performing both activities at low level, serves as a control group for physical activities and also to determine the importance of food reduction and food equilibrium in the treatment.
All subjects will have the same restrictive diet (500- 700 kcal/d). They will be followed for one year (at 3, 6 and 12 month), continuing at home the same program (diet and exercise training).
30 healthy subjects will be recruited for cross-sectional comparison (They will not follow any intervention, but will have the same investigation, only once).
Measured parameters Before and after the 3-week program and at 3, 6 and 12 months, the following measurements will be made Level of physical activities quantifying heart rate in each activity during the training 3 weeks and estimated thereafter on the same parameter.
Physical capacities With the 6 minute walking test, Food intake and equilibrium measured by full week records before training, during training and monthly thereafter. They will be quantified by a trained dietician using the reference French Cidal tables.
Metabolic syndrome factors Body composition including weight, height, abdominal circumference, total and torcular lean and total and abdominal fat mass measured by DXA Cardiac diastolic and systolic functions by means of standard, Tissue Doppler imaging and 2D-strain echocardiogram Vascular structure function in conduit and resistance arteries and microvascular reactivity Biological parameters with glycemic control : insulinemia and glaced haemoglobin Inflammatory syndrome and related cytokines: CRP, 1GPA, IL-6, TNF-, Il-12 and IL-10 blood protein: Albumine and transthyretin Appetite hormone: Leptine, adiponectin, Gremlin and CCK osteocalcin, BASP and CTx
Statical analysis Subject numbers were calculated from the results of a pilot. A statistical significance (p=0,05) may be reached with 22 subjects in group 1 and 2 for a difference of 0,6 kg of abdominal fat mass.
For cross-sectional comparison, healthy and MS subjects will be compared by unpaired Student test. The 3 groups of patients will be compared using a repeated measure ANOVA. If positive, a post-hoc test for mean comparison will be performed.
A correlation matrix will analyse relationships between studied parameters. A principal component analysis will allow to determine the reciprocal weight of positive explicating factors.
The study is done applying French and international regulations
- Conditions
- Metabolic Syndrome
- Being tested
- Type of physical activity (resistance, endurance), Restrictive diet
- Keywords
- Metabolic syndrome, exercise training, abdominal fat mass, endothelial function, diastolic function
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Type of physical activity (resistance, endurance)Behavioural
To determine which type of physical activity is the best to reduce metabolic syndrome parameters especially abdominal circumference.
Group 1 will perform mostly resistance activities, group 2 mostly endurance activities, and Group 3 performing both activities at low level, serves as a control group for physical activities.
Restrictive dietBehavioural
All subjects will have the same restrictive diet (500- 700 kcal/d).
What is being measured
The primary outcome is the main question the study is designed to answer.
Decreased abdominal fat mass, measured after one year. Such measured will be done repetitively at Day 0, 21 and at 3, 6 and 12 months using abdominal circumference and DXA Decreased cardio-vascular risks
Measured: at Day 0, 21 and at 3, 6 and 12 months using abdominal circumference and DXA
Secondary outcomes (1)
All the following measures will be done at day 0, 21 and at month 3, 6 and 12. Level of physical activities of each types Physical performances, Food intake and equilibrium Other Metabolic Syndrome inc
Measured: at day 0, 21 and at month 3, 6 and 12.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2009 (estimated)
- Study startMay 2009
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- Fondation Coeur et Artères
- Responsible party
- Sponsor
- Investigators
- Bruno Lesourd, MD, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00917917
- Sponsor's protocol ID
- CHU-0053
- Status last verified
- Jul 2026
- First submitted
- 9 Jun 2009
- Last updated
- 3 Aug 2026
- Results posted
- No
Publications
Vinet A, Obert P, Courteix D, Chapier R, Lesourd B, Verney J, Dutheil F, Walther G. Different modalities of exercise improve macrovascular function but not microvascular function in metabolic syndrome: The RESOLVE randomized trial. Int J Cardiol. 2018 Sep 15;267:165-170. doi: 10.1016/j.ijcard.2018.05.073. Epub 2018 May 23.
PubMed 29866368Lanhers C, Walther G, Chapier R, Lesourd B, Naughton G, Pereira B, Duclos M, Vinet A, Obert P, Courteix D, Dutheil F. Long-term cost reduction of routine medications following a residential programme combining physical activity and nutrition in the treatment of type 2 diabetes: a prospective cohort study. BMJ Open. 2017 Apr 16;7(4):e013763. doi: 10.1136/bmjopen-2016-013763.
PubMed 28416496Boudet G, Walther G, Courteix D, Obert P, Lesourd B, Pereira B, Chapier R, Vinet A, Chamoux A, Naughton G, Poirier P, Dutheil F. Paradoxical dissociation between heart rate and heart rate variability following different modalities of exercise in individuals with metabolic syndrome: The RESOLVE study. Eur J Prev Cardiol. 2017 Feb;24(3):281-296. doi: 10.1177/2047487316679523. Epub 2016 Nov 19.
PubMed 27856807Courteix D, Valente-dos-Santos J, Ferry B, Lac G, Lesourd B, Chapier R, Naughton G, Marceau G, Joao Coelho-e-Silva M, Vinet A, Walther G, Obert P, Dutheil F. Multilevel Approach of a 1-Year Program of Dietary and Exercise Interventions on Bone Mineral Content and Density in Metabolic Syndrome--the RESOLVE Randomized Controlled Trial. PLoS One. 2015 Sep 16;10(9):e0136491. doi: 10.1371/journal.pone.0136491. eCollection 2015.
PubMed 26376093Walther G, Obert P, Dutheil F, Chapier R, Lesourd B, Naughton G, Courteix D, Vinet A. Metabolic syndrome individuals with and without type 2 diabetes mellitus present generalized vascular dysfunction: cross-sectional study. Arterioscler Thromb Vasc Biol. 2015 Apr;35(4):1022-9. doi: 10.1161/ATVBAHA.114.304591. Epub 2015 Feb 5.
PubMed 25657309Serrano-Ferrer J, Walther G, Crendal E, Vinet A, Dutheil F, Naughton G, Lesourd B, Chapier R, Courteix D, Obert P. Right ventricle free wall mechanics in metabolic syndrome without type-2 diabetes: effects of a 3-month lifestyle intervention program. Cardiovasc Diabetol. 2014 Aug 3;13:116. doi: 10.1186/s12933-014-0116-9.
PubMed 25407698Vinet A, Obert P, Dutheil F, Diagne L, Chapier R, Lesourd B, Courteix D, Walther G. Impact of a lifestyle program on vascular insulin resistance in metabolic syndrome subjects: the RESOLVE study. J Clin Endocrinol Metab. 2015 Feb;100(2):442-50. doi: 10.1210/jc.2014-2704. Epub 2014 Oct 29.
PubMed 25353072Dutheil F, Walther G, Chapier R, Mnatzaganian G, Lesourd B, Naughton G, Verney J, Fogli A, Sapin V, Duclos M, Vinet A, Obert P, Courteix D, Lac G. Atherogenic subfractions of lipoproteins in the treatment of metabolic syndrome by physical activity and diet - the RESOLVE trial. Lipids Health Dis. 2014 Jul 11;13:112. doi: 10.1186/1476-511X-13-112.
PubMed 25015177Dutheil F, Lac G, Lesourd B, Chapier R, Walther G, Vinet A, Sapin V, Verney J, Ouchchane L, Duclos M, Obert P, Courteix D. Different modalities of exercise to reduce visceral fat mass and cardiovascular risk in metabolic syndrome: the RESOLVE randomized trial. Int J Cardiol. 2013 Oct 9;168(4):3634-42. doi: 10.1016/j.ijcard.2013.05.012. Epub 2013 May 25.
PubMed 23714599
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Combined Intervention of Physical Activity and Nutrition in Metabolic Syndrome Treatment on Cardio-vascular Risk and Muscular- Skeletal Functions in Human Subject. Analysis of Patient's Compliance in Patient's Follow-up.
- ClinicalTrials.gov ID
- NCT00917917
- Acronym / sponsor ID
- CHU-0053
- Conditions
- Metabolic Syndrome
- Keywords
- Metabolic syndrome, exercise training, abdominal fat mass, endothelial function, diastolic function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- Fondation Coeur et Artères
- Study start
- May 2009
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 11 Jun 2009 (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.
Metabolic syndrome has been defined as a group of associated risk factors for cardio-vascular diseases and diabetes. It is usually treated with an association of restrictive diet, physical exercise and drugs. Nevertheless the type of exercise associated to reduction in cardio-vascular risks is not yet fully defined. Long term effects of such hygienic-diet programs are of great importance since it is well-known that compliance to such treatment are of short duration, namely when subjects return in routine life. Metabolic syndrome volunteer subjects (n=90), aged 50 to 70 yrs will be randomly assigned to 3 groups of investigation.One group will perform mostly resistance activity, a second mainly endurance activity and the third one will be composed of subjects not exercising a lot. All subjects will have the same restrictive diet (500-700 kcal/d) After the initial training (3 weeks), they will return home with diet and physical program advises (personal compliance). They will be followed for one year (at 3, 6 and 12 months) Such a design may allow to find out the type of activity and power that are the best to reduce metabolic syndrome parameters and cardio-vascular risk factors.
The primary outcome variable is the reduction in abdominal circumference, which is the main criteria of MS.
Detailed description
The protocol is designed to determine which type of physical activity is the best to reduce metabolic syndrome parameters especially abdominal circumference.
90 Metabolic syndrome (MS) Patients will be recruited by advertising and checked for MS criteria. They will have a VO2max test in order to be sure they can perform physical activities safely. After being checked, patients will have an eight day period to think about participation and to ask questions before signing consent. They have to feel 3 questionnaires, one about regular physical activities, one about food intakes and a psychology one to measure reluctance to the program. After written informed consent obtained, patients will be randomly assigned to one of 3 groups of physical activity Group 1 will perform mostly resistance activities, group 2 mostly endurance activities, and group 3 performing both activities at low level, serves as a control group for physical activities and also to determine the importance of food reduction and food equilibrium in the treatment.
All subjects will have the same restrictive diet (500- 700 kcal/d). They will be followed for one year (at 3, 6 and 12 month), continuing at home the same program (diet and exercise training).
30 healthy subjects will be recruited for cross-sectional comparison (They will not follow any intervention, but will have the same investigation, only once).
Measured parameters Before and after the 3-week program and at 3, 6 and 12 months, the following measurements will be made Level of physical activities quantifying heart rate in each activity during the training 3 weeks and estimated thereafter on the same parameter.
Physical capacities With the 6 minute walking test, Food intake and equilibrium measured by full week records before training, during training and monthly thereafter. They will be quantified by a trained dietician using the reference French Cidal tables.
Metabolic syndrome factors Body composition including weight, height, abdominal circumference, total and torcular lean and total and abdominal fat mass measured by DXA Cardiac diastolic and systolic functions by means of standard, Tissue Doppler imaging and 2D-strain echocardiogram Vascular structure function in conduit and resistance arteries and microvascular reactivity Biological parameters with glycemic control : insulinemia and glaced haemoglobin Inflammatory syndrome and related cytokines: CRP, 1GPA, IL-6, TNF-, Il-12 and IL-10 blood protein: Albumine and transthyretin Appetite hormone: Leptine, adiponectin, Gremlin and CCK osteocalcin, BASP and CTx
Statical analysis Subject numbers were calculated from the results of a pilot. A statistical significance (p=0,05) may be reached with 22 subjects in group 1 and 2 for a difference of 0,6 kg of abdominal fat mass.
For cross-sectional comparison, healthy and MS subjects will be compared by unpaired Student test. The 3 groups of patients will be compared using a repeated measure ANOVA. If positive, a post-hoc test for mean comparison will be performed.
A correlation matrix will analyse relationships between studied parameters. A principal component analysis will allow to determine the reciprocal weight of positive explicating factors.
The study is done applying French and international regulations
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 50-70 years old from both sexes
- with metabolic syndrome
- affiliated to a social security system
- able to practice maximal physical exercises based on VO2 max
- able to sign inform consent
Key exclusion criteria (4 listed)
- recent (6 month) major health conditions and patients with recurrent health problems (1 per year)
- patients who are not capable to perform VO2 max without abnormalities
- dyserection treated patients
- patients with insufficient comprehensive ability to feel questionnaire and/or to change habits
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 |
|---|---|---|
| Type of physical activity (resistance, endurance)To determine which type of physical activity is the best to reduce metabolic syndrome parameters especially abdominal circumference. Group 1 will perform mostly resistance activities, group 2 mostly endurance activities, and Group 3 performing both activities at low level, serves as a control group for physical activities. | Behavioural | – |
| Restrictive dietAll subjects will have the same restrictive diet (500- 700 kcal/d). | Behavioural | – |
Primary outcome
Decreased abdominal fat mass, measured after one year. Such measured will be done repetitively at Day 0, 21 and at 3, 6 and 12 months using abdominal circumference and DXA Decreased cardio-vascular risks
Time frame: at Day 0, 21 and at 3, 6 and 12 months using abdominal circumference and DXA
1 secondary outcome
All the following measures will be done at day 0, 21 and at month 3, 6 and 12. Level of physical activities of each types Physical performances, Food intake and equilibrium Other Metabolic Syndrome inc
Time frame: at day 0, 21 and at month 3, 6 and 12.
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 3 Aug 2026.
- Derived from this study: PubMed 29866368Vinet A, Obert P, Courteix D, Chapier R, Lesourd B, Verney J, Dutheil F, Walther G. Different modalities of exercise improve macrovascular function but not microvascular function in metabolic syndrome: The RESOLVE randomized trial. Int J Cardiol. 2018 Sep 15;267:165-170. doi: 10.1016/j.ijcard.2018.05.073. Epub 2018 May 23.
- Derived from this study: PubMed 28416496Lanhers C, Walther G, Chapier R, Lesourd B, Naughton G, Pereira B, Duclos M, Vinet A, Obert P, Courteix D, Dutheil F. Long-term cost reduction of routine medications following a residential programme combining physical activity and nutrition in the treatment of type 2 diabetes: a prospective cohort study. BMJ Open. 2017 Apr 16;7(4):e013763. doi: 10.1136/bmjopen-2016-013763.
- Derived from this study: PubMed 27856807Boudet G, Walther G, Courteix D, Obert P, Lesourd B, Pereira B, Chapier R, Vinet A, Chamoux A, Naughton G, Poirier P, Dutheil F. Paradoxical dissociation between heart rate and heart rate variability following different modalities of exercise in individuals with metabolic syndrome: The RESOLVE study. Eur J Prev Cardiol. 2017 Feb;24(3):281-296. doi: 10.1177/2047487316679523. Epub 2016 Nov 19.
- Derived from this study: PubMed 26376093Courteix D, Valente-dos-Santos J, Ferry B, Lac G, Lesourd B, Chapier R, Naughton G, Marceau G, Joao Coelho-e-Silva M, Vinet A, Walther G, Obert P, Dutheil F. Multilevel Approach of a 1-Year Program of Dietary and Exercise Interventions on Bone Mineral Content and Density in Metabolic Syndrome--the RESOLVE Randomized Controlled Trial. PLoS One. 2015 Sep 16;10(9):e0136491. doi: 10.1371/journal.pone.0136491. eCollection 2015.
- Derived from this study: PubMed 25657309Walther G, Obert P, Dutheil F, Chapier R, Lesourd B, Naughton G, Courteix D, Vinet A. Metabolic syndrome individuals with and without type 2 diabetes mellitus present generalized vascular dysfunction: cross-sectional study. Arterioscler Thromb Vasc Biol. 2015 Apr;35(4):1022-9. doi: 10.1161/ATVBAHA.114.304591. Epub 2015 Feb 5.
- Derived from this study: PubMed 25407698Serrano-Ferrer J, Walther G, Crendal E, Vinet A, Dutheil F, Naughton G, Lesourd B, Chapier R, Courteix D, Obert P. Right ventricle free wall mechanics in metabolic syndrome without type-2 diabetes: effects of a 3-month lifestyle intervention program. Cardiovasc Diabetol. 2014 Aug 3;13:116. doi: 10.1186/s12933-014-0116-9.
- Derived from this study: PubMed 25353072Vinet A, Obert P, Dutheil F, Diagne L, Chapier R, Lesourd B, Courteix D, Walther G. Impact of a lifestyle program on vascular insulin resistance in metabolic syndrome subjects: the RESOLVE study. J Clin Endocrinol Metab. 2015 Feb;100(2):442-50. doi: 10.1210/jc.2014-2704. Epub 2014 Oct 29.
- Derived from this study: PubMed 25015177Dutheil F, Walther G, Chapier R, Mnatzaganian G, Lesourd B, Naughton G, Verney J, Fogli A, Sapin V, Duclos M, Vinet A, Obert P, Courteix D, Lac G. Atherogenic subfractions of lipoproteins in the treatment of metabolic syndrome by physical activity and diet - the RESOLVE trial. Lipids Health Dis. 2014 Jul 11;13:112. doi: 10.1186/1476-511X-13-112.
- Derived from this study: PubMed 23714599Dutheil F, Lac G, Lesourd B, Chapier R, Walther G, Vinet A, Sapin V, Verney J, Ouchchane L, Duclos M, Obert P, Courteix D. Different modalities of exercise to reduce visceral fat mass and cardiovascular risk in metabolic syndrome: the RESOLVE randomized trial. Int J Cardiol. 2013 Oct 9;168(4):3634-42. doi: 10.1016/j.ijcard.2013.05.012. Epub 2013 May 25.
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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.
Bruno Lesourd, MD principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Type of physical activity (resistance, endurance) and Restrictive diet in people with Metabolic Syndrome, run by University Hospital, Clermont-Ferrand at 1 site in France.
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 5 inclusion and 4 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 3 Aug 2026. 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 France. 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?
Decreased abdominal fat mass, measured after one year. Such measured will be done repetitively at Day 0, 21 and at 3, 6 and 12 months using abdominal circumference and DXA Decreased cardio-vascular risks (time frame: at Day 0, 21 and at 3, 6 and 12 months using abdominal circumference and DXA). 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 NCT00917917, which also lists 9 linked publications.
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 3 Aug 2026.