Body Weight and Vascular Function

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 28, 2014