Fertility and Cardiovascular Risk in Men With Metabolic Syndrome

Not Applicable

Recruiting

• Conditions: Metabolic Syndrome
• Interventions: Behavioral: Life style change and weight reduction

• Registration Number: NCT03977064
• Lead Sponsor: University of Giessen

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-06-04
• Study First Submitted QC: 2019-06-04
• Study First Posted: 2019-06-06
• Study Start: 2021-01-01
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-03
• Last Update Posted: 2021-11-11
• Primary Completion: 2023-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intensive treatment group	Life style change and weight reduction	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.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Justus Liebig University; 🇩🇪 Gießen, Germany