Metabolic SyndromeNCT01675401
Body Weight and Vascular Function
A study testing Weight-loss treatment and No-weight loss treatment in people with Metabolic Syndrome and Obesity, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
An increased body mass impairs vascular function (VF), an important characteristic of subjects suffering from type 2 diabetes and a risk marker for cardiovascular diseases. However, a wide variety of in vivo VF markers exists each measuring different aspects of VF. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome, Obesity
- What is being tested?
- Weight-loss treatment and No-weight loss treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteNetherlands
- Study dates
- Sep 2012to May 2014
- 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 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged between 18 and 65 years
- Waist circumference below 94 cm (lean subjects) or between 102 - 110 cm (abdominally overweight / obese subjects)
- Caucasian
- Plasma glucose < 7.0 mmol/L
- Serum total cholesterol < 8.0 mmol/L
- Serum triacylglycerol < 4.5 mmol/L
Show all 19Show fewer
- Plasma HbA1c < 6.5%
- No current smoker
- No diabetic patients
- No familial hypercholesterolemia
- No abuse of drugs
- Less than 14 alcoholic consumptions per week
- Stable body weight (weight gain or loss < 3 kg in the past three months)
- No use of medication known to affect blood pressure, serum lipid or glucose metabolism
- No severe medical conditions that might interfere with the study, such as epilepsy, asthma, chronic obstructive pulmonary disease, inflammatory bowel diseases, auto inflammatory diseases and rheumatoid arthritis
- No active cardiovascular disease like congestive heart failure or cardiovascular event, such as an acute myocardial infarction or cerebrovascular accident
- No contra-indications for MRI imaging
- Willingness to give up being a blood donor (or having donated blood) from 8 weeks before the start of the study, during the study and for 4 weeks after completion of the study
- No difficult venipuncture as evidenced during the screening visit
Who cannot join
- Women
- Non-caucasian
- Plasma glucose ≥ 7.0 mmol/L
- Serum total cholesterol ≥ 8.0 mmol/L
- Serum triacylglycerol ≥ 4.5 mmol/L
- Plasma HbA1c ≥ 6.5%
Show all 19Show fewer
- Current smoker, or smoking cessation < 12 months
- Diabetic patients
- Familial hypercholesterolemia
- Abuse of drugs
- More than 14 alcoholic consumptions per week
- Unstable body weight (weight gain or loss > 3 kg in the past three months)
- Use of use of medication known to affect blood pressure, serum lipid or glucose metabolism
- Severe medical conditions that might interfere with the study, such as epilepsy, asthma, chronic obstructive pulmonary disease, inflammatory bowel diseases, auto inflammatory diseases and rheumatoid arthritis
- Active cardiovascular disease like congestive heart failure or cardiovascular event, such as an acute myocardial infarction or cerebrovascular accident
- Contra-indications for MRI imaging
- Use of an investigational product within the previous 1-month
- Not willing to give up being a blood donor (or having donated blood) from 8 weeks before the start of the study, during the study or for 4 weeks after completion of the study
- Not or difficult to venipuncture as evidenced during the screening visit
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Vascular Function Markers: Differences Between Lean and Abdominally Overweight / Obese Men and Effects of Weight Loss
An increased body mass impairs vascular function (VF), an important characteristic of subjects suffering from type 2 diabetes and a risk marker for cardiovascular diseases. However, a wide variety of in vivo VF markers exists each measuring different aspects of VF. Each of these markers addresses a different aspect of the vasculature. Studies comparing under standardized conditions the differences and relationships of the many different VF measurements in lean and abdominally overweight / obese subjects are missing. Also, there is a great need to know which of these markers are sensitive to dietary challenges.
Therefore, it is imperative to conduct an extensive study on dietary effects and interrelationships of a broad spectrum of VF measurements and plasma biomarkers in lean and overweight / obese subjects. Focus will be on FMD, a well accepted biomarker for cardiovascular disease. The investigators propose to examine, in a two-way parallel-randomized human intervention study, the effects of weight-loss in abdominally overweight / obese men on VF markers and plasma biomarkers related to low-grade inflammation and vascular activity during the fasting and both the postprandial and hyperinsulinemic state. Furthermore, differences - and relations between - VF measurements and plasma biomarkers will be compared cross-sectionally between lean and abdominally overweight / obese male subjects.
- Conditions
- Metabolic Syndrome, Obesity
- Being tested
- Weight-loss treatment, No-weight loss treatment
- Keywords
- Body Weight, Obesity, Weight Loss, Vascular Function Markers
- Medical subject headings
- Metabolic Syndrome, Obesity, Body Weight, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weight-loss treatmentOther
A very-low energy diet (Modifast Intensive) for 4-5 weeks providing 2.1 MJ/day in order to reduce body weight. After 4-5 weeks a mixed solid energy-restricted diet up to 4.2 MJ/day with a recommended composition for the following 1-2 weeks. Then, a diet matching their energy requirements to maintain newly achieved body weights (weight-stable conditions) for at least 2 weeks.
No-weight loss treatmentOther
Maintenance of habitual diet and physical activity for 8 weeks to maintain body weights.
| Study group | Role | What they receive |
|---|---|---|
| Weight-loss treatment | Experimental | A very-low energy diet (Modifast Intensive) for 4-5 weeks providing 2.1 MJ/day in order to reduce body weight. After 4-5 weeks a mixed solid energy-restricted diet up to 4.2 MJ/day with a recommended composition for the following 1-2 weeks. Then, a diet matching their energy requirements to maintain newly achieved body weights (weight-stable conditions) for at least 2 weeks. Receives: Other: Weight-loss treatment |
| No-weight loss treatment | Other | Maintenance of habitual diet and physical activity for 8 weeks to maintain body weights. Receives: Other: No-weight loss treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vascular activity: differences between lean and abdominally overweight / obese men and effects of weight loss
Flow-mediated dilation (FMD) of the brachial artery.
Measured: Difference after weight-loss due to restriction of energy intake for 8 weeks and change from baseline at 2 hours after meal consumption
Secondary outcomes (3)
Vascular function markers related to the macrovasculature: differences between lean and abdominally overweight / obese men and effects of weight loss
Carotid-wall intima-media thickness (IMT), carotid compliance and distensibility, pulse wave velocity and analysis (PWV and PWA) and peripheral artery tonometry (PAT).
Measured: Difference after weight-loss due to restriction of energy intake for 8 weeks and change from baseline during the postprandial (at 2 hours after meal consumption) / hyperinsulinemic state (at 2 hours after initiation of the clamp)
Vascular function markers related to the microvasculature: differences between lean and abdominally overweight / obese men and effects of weight loss
Capillary video microscopy of the finger skin, skin microvascular vasomotion, glycocalyx thickness, retina photography, skin auto fluorescence and contrast enhanced ultrasound (CEUS) in skeletal muscle.
Measured: Difference after weight-loss due to restriction of energy intake for 8 weeks and change from baseline during the postprandial (at 1 and 3 hours after meal consumption) / hyperinsulinemic state (at 2 hours after initiation of the clamp)
Metabolic risk markers related to the metabolic syndrome: differences between lean and abdominally overweight / obese men and effects of weight loss
Biomarkers for low-grade inflammation and endothelial activation.
Measured: Difference after weight-loss due to restriction of energy intake for 8 weeks and change from baseline during the postprandial (during 4 hours after meal consumption) / hyperinsulinemic state (during 3 hours after initiation of the clamp)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2012 (estimated)
- Study startSep 2012
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)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 Maastricht University Medical CenterThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Top Institute Food and Nutrition
- Responsible party
- Sponsor
- Investigators
- Ronald P Mensink, PhD, Principal investigator, Maastricht University Medical CenterCasper G Schalkwijk, PhD, Principal investigator, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01675401
- Sponsor's protocol ID
- MEC 12-3-040
- Status last verified
- Oct 2016
- First submitted
- 21 Aug 2012
- Last updated
- 1 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Van den Eynde MDG, Kusters YHAM, Houben AJHM, Scheijen JLJM, van Duynhoven J, Fazelzadeh P, Joris PJ, Plat J, Mensink RP, Hanssen NMJ, Stehouwer CDA, Schalkwijk CG. Diet-induced weight loss reduces postprandial dicarbonyl stress in abdominally obese men: Secondary analysis of a randomized controlled trial. Clin Nutr. 2021 May;40(5):2654-2662. doi: 10.1016/j.clnu.2021.03.042. Epub 2021 Apr 15.
PubMed 33933731Joris PJ, Plat J, Kusters YHAM, Houben AJHM, Stehouwer CDA, Schalkwijk CG, Mensink RP. Effects of diet-induced weight loss on postprandial vascular function after consumption of a mixed meal: Results of a randomized controlled trial with abdominally obese men. Clin Nutr. 2020 Oct;39(10):2998-3004. doi: 10.1016/j.clnu.2020.01.006. Epub 2020 Jan 13.
PubMed 31982191Fazelzadeh P, Hoefsloot HCJ, Hankemeier T, Most J, Kersten S, Blaak EE, Boekschoten M, van Duynhoven J. Global testing of shifts in metabolic phenotype. Metabolomics. 2018 Oct 4;14(10):139. doi: 10.1007/s11306-018-1435-8.
PubMed 30830386Telgenkamp I, Kusters YHAM, Schalkwijk CG, Houben AJHM, Kooi ME, Lindeboom L, Bons JAP, Schaper NC, Joris PJ, Plat J, Mensink RP, Stehouwer CDA, Brouwers MCGJ. Contribution of Liver Fat to Weight Loss-Induced Changes in Serum Hepatokines: A Randomized Controlled Trial. J Clin Endocrinol Metab. 2019 Jul 1;104(7):2719-2727. doi: 10.1210/jc.2018-02378.
PubMed 30753672Schutten MTJ, Kusters YHAM, Houben AJHM, Scheijen JLJM, van de Waarenburg MPH, Schalkwijk CG, Joris PJ, Plat J, Mensink RP, de Leeuw PW, Stehouwer CDA. Aldosterone Is Not Associated With Metabolic and Microvascular Insulin Sensitivity in Abdominally Obese Men. J Clin Endocrinol Metab. 2018 Feb 1;103(2):759-767. doi: 10.1210/jc.2017-01541.
PubMed 29211893Kusters YH, Schalkwijk CG, Houben AJ, Kooi ME, Lindeboom L, Op 't Roodt J, Joris PJ, Plat J, Mensink RP, Barrett EJ, Stehouwer CD. Independent tissue contributors to obesity-associated insulin resistance. JCI Insight. 2017 Jul 6;2(13):e89695. doi: 10.1172/jci.insight.89695. eCollection 2017 Jul 6.
PubMed 28679946Joris PJ, Plat J, Kusters YH, Houben AJ, Stehouwer CD, Schalkwijk CG, Mensink RP. Diet-induced weight loss improves not only cardiometabolic risk markers but also markers of vascular function: a randomized controlled trial in abdominally obese men. Am J Clin Nutr. 2017 Jan;105(1):23-31. doi: 10.3945/ajcn.116.143552. Epub 2016 Nov 23.
PubMed 27881395
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vascular Function Markers: Differences Between Lean and Abdominally Overweight / Obese Men and Effects of Weight Loss
- ClinicalTrials.gov ID
- NCT01675401
- Acronym / sponsor ID
- MEC 12-3-040
- Conditions
- Metabolic Syndrome, Obesity
- Keywords
- Body Weight, Obesity, Weight Loss, Vascular Function Markers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- Top Institute Food and Nutrition
- Study start
- Sep 2012
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 30 Aug 2012 (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.
An increased body mass impairs vascular function (VF), an important characteristic of subjects suffering from type 2 diabetes and a risk marker for cardiovascular diseases. However, a wide variety of in vivo VF markers exists each measuring different aspects of VF. Each of these markers addresses a different aspect of the vasculature. Studies comparing under standardized conditions the differences and relationships of the many different VF measurements in lean and abdominally overweight / obese subjects are missing. Also, there is a great need to know which of these markers are sensitive to dietary challenges.
Therefore, it is imperative to conduct an extensive study on dietary effects and interrelationships of a broad spectrum of VF measurements and plasma biomarkers in lean and overweight / obese subjects. Focus will be on FMD, a well accepted biomarker for cardiovascular disease. The investigators propose to examine, in a two-way parallel-randomized human intervention study, the effects of weight-loss in abdominally overweight / obese men on VF markers and plasma biomarkers related to low-grade inflammation and vascular activity during the fasting and both the postprandial and hyperinsulinemic state. Furthermore, differences - and relations between - VF measurements and plasma biomarkers will be compared cross-sectionally between lean and abdominally overweight / obese male subjects.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Weight-loss treatment | Experimental | Other: Weight-loss treatmentA very-low energy diet (Modifast Intensive) for 4-5 weeks providing 2.1 MJ/day in order to reduce body weight. After 4-5 weeks a mixed solid energy-restricted diet up to 4.2 MJ/day with a recommended composition for the following 1-2 weeks. Then, a diet matching their energy requirements to maintain newly achieved body weights (weight-stable conditions) for at least 2 weeks. |
| No-weight loss treatment | Other | Other: No-weight loss treatmentMaintenance of habitual diet and physical activity for 8 weeks to maintain body weights. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Aged between 18 and 65 years
- Waist circumference below 94 cm (lean subjects) or between 102 - 110 cm (abdominally overweight / obese subjects)
- Caucasian
- Plasma glucose < 7.0 mmol/L
- Serum total cholesterol < 8.0 mmol/L
Key exclusion criteria (19 listed)
- Women
- Non-caucasian
- Plasma glucose ≥ 7.0 mmol/L
- Serum total cholesterol ≥ 8.0 mmol/L
- Serum triacylglycerol ≥ 4.5 mmol/L
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 |
|---|---|---|
| Weight-loss treatmentA very-low energy diet (Modifast Intensive) for 4-5 weeks providing 2.1 MJ/day in order to reduce body weight. After 4-5 weeks a mixed solid energy-restricted diet up to 4.2 MJ/day with a recommended composition for the following 1-2 weeks. Then, a diet matching their energy requirements to maintain newly achieved body weights (weight-stable conditions) for at least 2 weeks. | Other | Weight-loss treatment |
| No-weight loss treatmentMaintenance of habitual diet and physical activity for 8 weeks to maintain body weights. | Other | No-weight loss treatment |
Primary outcome
Vascular activity: differences between lean and abdominally overweight / obese men and effects of weight loss
Time frame: Difference after weight-loss due to restriction of energy intake for 8 weeks and change from baseline at 2 hours after meal consumption
Flow-mediated dilation (FMD) of the brachial artery.
3 secondary outcomes
Vascular function markers related to the macrovasculature: differences between lean and abdominally overweight / obese men and effects of weight loss
Time frame: Difference after weight-loss due to restriction of energy intake for 8 weeks and change from baseline during the postprandial (at 2 hours after meal consumption) / hyperinsulinemic state (at 2 hours after initiation of the clamp)
Vascular function markers related to the microvasculature: differences between lean and abdominally overweight / obese men and effects of weight loss
Time frame: Difference after weight-loss due to restriction of energy intake for 8 weeks and change from baseline during the postprandial (at 1 and 3 hours after meal consumption) / hyperinsulinemic state (at 2 hours after initiation of the clamp)
Metabolic risk markers related to the metabolic syndrome: differences between lean and abdominally overweight / obese men and effects of weight loss
Time frame: Difference after weight-loss due to restriction of energy intake for 8 weeks and change from baseline during the postprandial (during 4 hours after meal consumption) / hyperinsulinemic state (during 3 hours after initiation of the clamp)
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 1 Nov 2016.
- Derived from this study: PubMed 33933731Van den Eynde MDG, Kusters YHAM, Houben AJHM, Scheijen JLJM, van Duynhoven J, Fazelzadeh P, Joris PJ, Plat J, Mensink RP, Hanssen NMJ, Stehouwer CDA, Schalkwijk CG. Diet-induced weight loss reduces postprandial dicarbonyl stress in abdominally obese men: Secondary analysis of a randomized controlled trial. Clin Nutr. 2021 May;40(5):2654-2662. doi: 10.1016/j.clnu.2021.03.042. Epub 2021 Apr 15.
- Derived from this study: PubMed 31982191Joris PJ, Plat J, Kusters YHAM, Houben AJHM, Stehouwer CDA, Schalkwijk CG, Mensink RP. Effects of diet-induced weight loss on postprandial vascular function after consumption of a mixed meal: Results of a randomized controlled trial with abdominally obese men. Clin Nutr. 2020 Oct;39(10):2998-3004. doi: 10.1016/j.clnu.2020.01.006. Epub 2020 Jan 13.
- Derived from this study: PubMed 30830386Fazelzadeh P, Hoefsloot HCJ, Hankemeier T, Most J, Kersten S, Blaak EE, Boekschoten M, van Duynhoven J. Global testing of shifts in metabolic phenotype. Metabolomics. 2018 Oct 4;14(10):139. doi: 10.1007/s11306-018-1435-8.
- Derived from this study: PubMed 30753672Telgenkamp I, Kusters YHAM, Schalkwijk CG, Houben AJHM, Kooi ME, Lindeboom L, Bons JAP, Schaper NC, Joris PJ, Plat J, Mensink RP, Stehouwer CDA, Brouwers MCGJ. Contribution of Liver Fat to Weight Loss-Induced Changes in Serum Hepatokines: A Randomized Controlled Trial. J Clin Endocrinol Metab. 2019 Jul 1;104(7):2719-2727. doi: 10.1210/jc.2018-02378.
- Derived from this study: PubMed 29211893Schutten MTJ, Kusters YHAM, Houben AJHM, Scheijen JLJM, van de Waarenburg MPH, Schalkwijk CG, Joris PJ, Plat J, Mensink RP, de Leeuw PW, Stehouwer CDA. Aldosterone Is Not Associated With Metabolic and Microvascular Insulin Sensitivity in Abdominally Obese Men. J Clin Endocrinol Metab. 2018 Feb 1;103(2):759-767. doi: 10.1210/jc.2017-01541.
- Derived from this study: PubMed 28679946Kusters YH, Schalkwijk CG, Houben AJ, Kooi ME, Lindeboom L, Op 't Roodt J, Joris PJ, Plat J, Mensink RP, Barrett EJ, Stehouwer CD. Independent tissue contributors to obesity-associated insulin resistance. JCI Insight. 2017 Jul 6;2(13):e89695. doi: 10.1172/jci.insight.89695. eCollection 2017 Jul 6.
- Derived from this study: PubMed 27881395Joris PJ, Plat J, Kusters YH, Houben AJ, Stehouwer CD, Schalkwijk CG, Mensink RP. Diet-induced weight loss improves not only cardiometabolic risk markers but also markers of vascular function: a randomized controlled trial in abdominally obese men. Am J Clin Nutr. 2017 Jan;105(1):23-31. doi: 10.3945/ajcn.116.143552. Epub 2016 Nov 23.
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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.
Ronald P Mensink, PhD principal investigator
Maastricht University Medical Center
Casper G Schalkwijk, PhD principal investigator
Maastricht University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Weight-loss treatment and No-weight loss treatment in people with Metabolic Syndrome and Obesity, run by Maastricht University Medical Center at 1 site in Netherlands.
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 19 inclusion and 19 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 1 Nov 2016. 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 Netherlands. 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?
Vascular activity: differences between lean and abdominally overweight / obese men and effects of weight loss (time frame: Difference after weight-loss due to restriction of energy intake for 8 weeks and change from baseline at 2 hours after meal consumption). 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 NCT01675401, which also lists 7 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 1 Nov 2016.