Back to resultsFertility and Cardiovascular Risk in Men With Metabolic Syndrome
Primary Purpose
Metabolic Syndrome
Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Life style change and weight reduction
Sponsored by
About this trial
This is an interventional health services research trial for Metabolic Syndrome
Eligibility Criteria
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
Sites / Locations
- Justus Liebig UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intensive treatment group
Standard treatment group
Arm Description
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.
Patients will be taken care of by general physician without lifestyle program.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03977064
Brief Title
Fertility and Cardiovascular Risk in Men With Metabolic Syndrome
Official Title
Fertility and Cardiovascular Risk in Men With Metabolic Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Giessen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
The outcomes assessor will receive pseudonymous data
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intensive treatment group
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard treatment group
Arm Type
No Intervention
Arm Description
Patients will be taken care of by general physician without lifestyle program.
Intervention Type
Behavioral
Intervention Name(s)
Life style change and weight reduction
Intervention Description
Nutritional, behavioural, and exercise counselling to reduce body weight by 10%, normalise blood glucose, lipids, blood pressure, and testosterone level.
Primary Outcome Measure Information:
Title
Number of participants with normalisation of diabetes or cardiovascular risk or improvement of hypogonadism
Description
Diabetes risk Glycated hemoglobin >5.7%, Cardiovascular risk score >5%, Hypogonadism score increase of 20 points
Time Frame
1 year
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
Males diagnosed with metabolic syndrome
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Thomas Linn, MD
Phone
+49 641 985 57017
Email
thomas.linn@innere.med.uni-giessen.de
Facility Information:
Facility Name
Justus Liebig University
City
Gießen
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Linn
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Fertility and Cardiovascular Risk in Men With Metabolic Syndrome
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