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Body Weight and Vascular Function

Primary Purpose

Metabolic Syndrome, Obesity

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Weight-loss treatment
No-weight loss treatment
Sponsored by
Maastricht University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Metabolic Syndrome focused on measuring Body Weight, Obesity, Weight Loss, Vascular Function Markers

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • 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
  • 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

Exclusion Criteria:

  • 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%
  • 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

Sites / Locations

  • Maastricht University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Weight-loss treatment

No-weight loss treatment

Arm Description

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.

Maintenance of habitual diet and physical activity for 8 weeks to maintain body weights.

Outcomes

Primary Outcome Measures

Vascular activity: differences between lean and abdominally overweight / obese men and effects of weight loss
Flow-mediated dilation (FMD) of the brachial artery.

Secondary Outcome Measures

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).
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.
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.

Full Information

First Posted
August 21, 2012
Last Updated
October 31, 2016
Sponsor
Maastricht University Medical Center
Collaborators
Top Institute Food and Nutrition
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1. Study Identification

Unique Protocol Identification Number
NCT01675401
Brief Title
Body Weight and Vascular Function
Official Title
Vascular Function Markers: Differences Between Lean and Abdominally Overweight / Obese Men and Effects of Weight Loss
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maastricht University Medical Center
Collaborators
Top Institute Food and Nutrition

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome, Obesity
Keywords
Body Weight, Obesity, Weight Loss, Vascular Function Markers

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Weight-loss treatment
Arm Type
Experimental
Arm Description
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.
Arm Title
No-weight loss treatment
Arm Type
Other
Arm Description
Maintenance of habitual diet and physical activity for 8 weeks to maintain body weights.
Intervention Type
Other
Intervention Name(s)
Weight-loss treatment
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
No-weight loss treatment
Intervention Description
Maintenance of habitual diet and physical activity for 8 weeks to maintain body weights.
Primary Outcome Measure Information:
Title
Vascular activity: differences between lean and abdominally overweight / obese men and effects of weight loss
Description
Flow-mediated dilation (FMD) of the brachial artery.
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
Secondary Outcome Measure Information:
Title
Vascular function markers related to the macrovasculature: differences between lean and abdominally overweight / obese men and effects of weight loss
Description
Carotid-wall intima-media thickness (IMT), carotid compliance and distensibility, pulse wave velocity and analysis (PWV and PWA) and peripheral artery tonometry (PAT).
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)
Title
Vascular function markers related to the microvasculature: differences between lean and abdominally overweight / obese men and effects of weight loss
Description
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.
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)
Title
Metabolic risk markers related to the metabolic syndrome: differences between lean and abdominally overweight / obese men and effects of weight loss
Description
Biomarkers for low-grade inflammation and endothelial activation.
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)
Other Pre-specified Outcome Measures:
Title
Body fat components and fat content of intra-abdominal organs: differences between lean and abdominally overweight / obese men and effects of weight loss
Description
Dixon MRI measurements in order to quantify abdominal fat compartments (i.e. subcutaneous and visceral fat) and fat content of abdominal organs (i.e. liver).
Time Frame
Difference after weight-loss due to restriction of energy intake for 8 weeks
Title
Blood pressure: difference between lean and abdominally overweight / obese men and effects of weight loss
Description
24-hr ambulatory blood pressure
Time Frame
Difference after weight-loss due to restriction of energy intake for 8 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 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 Exclusion Criteria: 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% 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronald P Mensink, PhD
Organizational Affiliation
Maastricht University Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Casper G Schalkwijk, PhD
Organizational Affiliation
Maastricht University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maastricht University Medical Center
City
Maastricht
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
33933731
Citation
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.
Results Reference
derived
PubMed Identifier
31982191
Citation
Joris 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.
Results Reference
derived
PubMed Identifier
30830386
Citation
Fazelzadeh 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.
Results Reference
derived
PubMed Identifier
30753672
Citation
Telgenkamp 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.
Results Reference
derived
PubMed Identifier
29211893
Citation
Schutten 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.
Results Reference
derived
PubMed Identifier
28679946
Citation
Kusters 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.
Results Reference
derived
PubMed Identifier
27881395
Citation
Joris 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.
Results Reference
derived

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Body Weight and Vascular Function

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