Fertility and Cardiovascular Risk in Men With Metabolic Syndrome

• Sponsor: University of Giessen (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03977064
• Collaborator: (none)
• Enrollment: 70
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 48
• Patients Per Site Per Month: 1.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Metabolic Syndrome	Behavioral: Life style change and weight reduction	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 70 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Masking Description: The outcomes assessor will receive pseudonymous data
• Primary Purpose: Health Services Research
• Official Title: Fertility and Cardiovascular Risk in Men With Metabolic Syndrome
• Actual Study Start Date: Jan 1, 2021
• Anticipated Primary Completion Date: Dec 31, 2023
• Anticipated Study Completion Date: Dec 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intensive treatment group 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; Nutritional, behavioural, and exercise counselling to reduce body weight by 10%, normalise blood glucose, lipids, blood pressure, and testosterone level.
No Intervention: Standard treatment group Patients will be taken care of by general physician without lifestyle program.

Outcome Measures

Primary Outcome Measures

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Justus Liebig University	Gießen		Germany

Sponsors and Collaborators

• University of Giessen

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Giessen
• ClinicalTrials.gov Identifier: NCT03977064
• Other Study ID Numbers: EK205/16
• First Posted: Jun 6, 2019
• Last Update Posted: Nov 11, 2021
• Last Verified: Nov 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Metabolic Syndrome; Syndrome

Study Results

No Results Posted as of Nov 11, 2021