Body Weight and Vascular Function

This study is currently recruiting participants.
Verified March 2014 by Maastricht University Medical Center
Sponsor:
Collaborator:
Top Institute Food and Nutrition
Information provided by (Responsible Party):
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT01675401
First received: August 21, 2012
Last updated: March 17, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Metabolic Syndrome
Obesity
Other: Weight-loss treatment
Other: No-weight loss treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Vascular Function Markers: Differences Between Lean and Abdominally Overweight / Obese Men and Effects of Weight Loss

Resource links provided by NLM:


Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 [ 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) ] [ Designated as safety issue: No ]
    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 [ 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) ] [ Designated as safety issue: No ]
    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 [ 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) ] [ Designated as safety issue: No ]
    Biomarkers for low-grade inflammation and endothelial activation.


Other Outcome Measures:
  • Body fat components and fat content of intra-abdominal organs: 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 ] [ Designated as safety issue: No ]
    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).

  • Blood pressure: difference 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 ] [ Designated as safety issue: No ]
    24-hr ambulatory blood pressure


Estimated Enrollment: 75
Study Start Date: September 2012
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Weight-loss treatment
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.
Other: Weight-loss treatment
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 treatment
Maintenance of habitual diet and physical activity for 8 weeks to maintain body weights.
Other: No-weight loss treatment
Maintenance of habitual diet and physical activity for 8 weeks to maintain body weights.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01675401

Contacts
Contact: Daisy Luiten +31(0)433881313 afvalstudie@maastrichtuniversity.nl

Locations
Netherlands
Maastricht University Medical Center Recruiting
Maastricht, Netherlands
Contact: Peter J Joris, M.Sc.    +31(0)433881313    p.joris@maastrichtuniversity.nl   
Maastricht University Medical Center Recruiting
Maastricht, Netherlands
Contact: Yvo H Kusters, MD    +31(0)433882138    y.kusters@maastrichtuniversity.nl   
Sponsors and Collaborators
Maastricht University Medical Center
Top Institute Food and Nutrition
Investigators
Principal Investigator: Ronald P Mensink, PhD Maastricht University Medical Center
Principal Investigator: Casper G Schalkwijk, PhD Maastricht University Medical Center
  More Information

No publications provided

Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT01675401     History of Changes
Other Study ID Numbers: MEC 12-3-040
Study First Received: August 21, 2012
Last Updated: March 17, 2014
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Maastricht University Medical Center:
Body Weight
Obesity
Weight Loss
Vascular Function Markers

Additional relevant MeSH terms:
Body Weight
Obesity
Metabolic Syndrome X
Signs and Symptoms
Overnutrition
Nutrition Disorders
Overweight
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on April 16, 2014