Fertility and Cardiovascular Risk in Men With Metabolic Syndrome

NCT03977064 | Unknown

• 1 other identifier: EK205/16
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Metabolic Syndrome

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Intensive treatment group

EXPERIMENTAL

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.

Behavioral: Life style change and weight reduction

Standard treatment group

NO INTERVENTION

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

Interventions

Life style change and weight reduction BEHAVIORAL

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

Intensive treatment group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Males diagnosed with metabolic syndrome
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Not conforming to MetS diagnosis criteria, sterilisation, promiscuous behaviour, contraindications against established medical or surgical treatment of obesity, participation in another weight-loss program

Sponsors & Collaborators

• University of Giessen: lead

Study Sites (1)

Justus Liebig University

Giessen, Germany

RECRUITING

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Thomas Linn, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcomes assessor will receive pseudonymous data
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2019
• First Posted: June 6, 2019
• Study Start: January 1, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2024
• Last Updated: November 11, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)