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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON39694

Enrollment

Registered

2012-09-03

Start date

2012-10-10

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insulin Resistance Syndrome Metabolic Syndrome Syndrome X

Interventions

Lean subjects will only be studied cross-sectionally, and obese / overweight subjects before and after random assignment to a weight-loss intervention. Subjects assigned to the energy-intake restric

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Aged between 18 and 65 years - Waist circumference below 94 cm or between 102-110 cm - Caucasian - Mean plasma glucose

Exclusion criteria

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 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 (

Design outcomes

Primary

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

Secondary

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

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)