Vascular Function Markers: Differences Between Lean and Abdominally Overweight / Obese Men and Effects of Weight Loss
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 75
- Locations
- 1
- Primary Endpoint
- Vascular activity: differences between lean and abdominally overweight / obese men and effects of weight loss
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
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
- •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
Arms & Interventions
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.
Intervention: Weight-loss treatment (Other)
No-weight loss treatment
Maintenance of habitual diet and physical activity for 8 weeks to maintain body weights.
Intervention: No-weight loss treatment (Other)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Vascular function markers related to the macrovasculature: differences between lean and abdominally overweight / obese men and effects of weight loss(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(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(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))