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NCT03977064 Clinical Trial

Fertility and Cardiovascular Risk in Men With Metabolic Syndrome

Metabolic Syndrome Clinical Trial

Official title:
Fertility and Cardiovascular Risk in Men With Metabolic Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03977064
Other study ID # EK205/16
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 1, 2021
Est. completion date December 31, 2024

Study information
Verified date November 2021
Source University of Giessen
Contact Thomas Linn, MD
Phone +49 641 985 57017
Email thomas.linn@innere.med.uni-giessen.de
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 70
Est. completion date December 31, 2024
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Behavioral:
• Life 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.

Locations
Country Name City State
Germany Justus Liebig University Gießen

Sponsors (1)
Lead Sponsor Collaborator
University of Giessen

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 1 year
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