Metabolic Syndrome
Conditions
Brief summary
Men diagnosed with metabolic syndrome (MetS) including obesity, hypertension, dyslipidemia and infertility will be assessed for cardiovascular and diabetes risk. The eligible patient will be randomised to one-year life-style intervention program including nutritional, behavioural and exercise counselling or standard care by the general physician. The aim of the program is to reduce cardiovascular and diabetes risks and hypogonadism as well.
Interventions
BEHAVIORALLife style change and weight reduction
Nutritional, behavioural, and exercise counselling to reduce body weight by 10%, normalise blood glucose, lipids, blood pressure, and testosterone level.
Sponsors
University of Giessen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Masking description
The outcomes assessor will receive pseudonymous data
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age\>18 years, wish for fatherhood in stable partnership, metabolic syndrome according to guidelines (minimum 3 out of 5 criteria), ready to participate in 1-yr lifestyle program
Exclusion criteria
* Not conforming to MetS diagnosis criteria, sterilisation, promiscuous behaviour, contraindications against established medical or surgical treatment of obesity, participation in another weight-loss program
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with normalisation of diabetes or cardiovascular risk or improvement of hypogonadism | 1 year | Diabetes risk Glycated hemoglobin \>5.7%, Cardiovascular risk score \>5%, Hypogonadism score increase of 20 points |
Countries
Germany
Contacts
Primary ContactThomas Linn, MD
Outcome results
None listed