Vascular function markers: differences between lean and abdominally overweight / obese men and effects of weight loss

Completed

Conditions: Insulin Resistance Syndrome
Metabolic Syndrome
Syndrome X
10013317

Registration Number: NL-OMON39694

Lead Sponsor: Medisch Universitair Ziekenhuis Maastricht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 75

Inclusion Criteria

- Aged between 18 and 65 years
- Waist circumference below 94 cm or between 102-110 cm
- Caucasian
- Mean plasma glucose < 7.0 mmol/L
- Mean serum total cholesterol < 8.0 mmol/L
- Mean triaclglycerol < 4.5 mmol/L
- Plasma Hba1c < 6.5%
- No current smoker
- No diabetic patients or individuals receiving antidiabetic medication
- 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 bood pressure, serum lipid or glucose metabolism
- No indication for blood pressure lowering treatment
- 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 cerebro vascular accident
- No contra-indications for MRI imaging (e.g. pacemaker, surgical clips/material in body, metal splinter in eye, claustrophobia)
- 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
- Willingness to stop the consumption of vitamins, minerals and (food) supplements from 3 weeks before the start of the study and during the study

Exclusion Criteria

- Women
- Non-caucasian
- Mean plasma glucose * 7.0 mmol/L
- Mean serum total cholesterol * 8.0 mmol/L
- Mean triaclglycerol * 4.5 mmol/L
- Plasma HbA1c * 6.5%
- Current smoker, or smoking cessation < 12 months
- Diabetic patients or individuals receiving antidiabetic medication
- 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
- Indication for blood pressure lowering treatment
- 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
- Active cardiovascular disease like congestive heart failure or recent (< 6 months) event, such as an acute myocardial infarction or cerebro vascular accident
- Contra-indications for MRI imaging (e.g. pacemaker, surgical clips/materials in body, metal splinter in eye, claustrophobia)
- 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
- Not willing to stop the consumption of vitamins, minerals o (food) supplements from 3 weeks before the start of the study and during the study

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Parameters related to in vivo VF markers will be studied.<br /><br><br /><br><br /><br>The primary endpoint is the difference in flow mediated dilation (FMD) of the<br /><br>brachial artery<br /><br><br /><br>- between lean and abdominally overweight / obese male subjects.<br /><br>- in abdominally overweight / obese men after weight-loss due to restriction of<br /><br>energy intake</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints are differences in * and relations between * other VF<br /><br>measurements and of plasma biomarkers related to low-grade inflammation and<br /><br>vascular activity<br /><br><br /><br>- between lean and abdominally overweight / obese male subjects<br /><br>- in abdominally overweight / obese men after weight-loss dure to restriction<br /><br>of energy intake<br /><br>- during the fasting and postprandial / hyperinsulinemic state</p><br>