Fertility and Cardiovascular Risk in Men With Metabolic Syndrome

University of Giessen70 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

SINGLE

Enrollment

Conditions

Metabolic Syndrome

Interventions

Life style change and weight reductionBEHAVIORAL

Nutritional, behavioural, and exercise counselling to reduce body weight by 10%, normalise blood glucose, lipids, blood pressure, and testosterone level.

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Justus Liebig University

Giessen, Germany

RECRUITING

Outcomes

Primary Outcomes

Number of participants with normalisation of diabetes or cardiovascular risk or improvement of hypogonadism

Diabetes risk Glycated hemoglobin \>5.7%, Cardiovascular risk score \>5%, Hypogonadism score increase of 20 points

Time frame: 1 year

Central Contacts

Thomas Linn, MD

CONTACT

+49 641 985 57017 thomas.linn@innere.med.uni-giessen.de

Data from ClinicalTrials.gov

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