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Fertility and Cardiovascular Risk in Men With Metabolic Syndrome

NCT ID: NCT03977064

Last Updated: 2021-11-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-01

Study Completion Date

2024-12-31

Brief Summary

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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

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Conditions

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Metabolic Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors
The outcomes assessor will receive pseudonymous data

Study Groups

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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.

Group Type EXPERIMENTAL

Life style change and weight reduction

Intervention Type BEHAVIORAL

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

Standard treatment group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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University of Giessen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Justus Liebig University

Giessen, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Thomas Linn, MD

Role: CONTACT

Phone: +49 641 985 57017

Email: [email protected]

Facility Contacts

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Thomas Linn

Role: primary

Other Identifiers

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EK205/16

Identifier Type: -

Identifier Source: org_study_id