Body Weight and Vascular Function

Maastricht University Medical Centre (MUMC)

Status: Completed

Conditions: Obesity; Metabolic Syndrome

Treatments: Other: Weight-loss treatment; Other: No-weight loss treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT01675401

MEC 12-3-040

Details and patient eligibility

About

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.

Enrollment: 75 patients

Sex: Male

Ages: 18 to 65 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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75 participants in 2 patient groups

Weight-loss treatment

Experimental group

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.

Treatment:

Other: Weight-loss treatment

No-weight loss treatment

Other group

Description:

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

Treatment:

Other: No-weight loss treatment