Fertility and Cardiovascular Risk in Men With Metabolic Syndrome

University of Giessen

Status: Enrolling

Conditions: Metabolic Syndrome

Treatments: Behavioral: Life style change and weight reduction

Study type: Interventional

Funder types: Other

Identifiers

NCT03977064

EK205/16

Details and patient eligibility

About

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.

Enrollment: 70 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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70 participants in 2 patient groups

Intensive treatment group

Experimental group

Description:

The intensive treatment group will pass a life-style intervention program including consequent escalation of measures to reach sustained reduction of 10% of initial body weight at minimum.

Treatment:

Behavioral: Life style change and weight reduction

Standard treatment group

No Intervention group

Description:

Patients will be taken care of by general physician without lifestyle program.