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出境医 / 临床实验 / Fertility and Cardiovascular Risk in Men With Metabolic Syndrome

Fertility and Cardiovascular Risk in Men With Metabolic Syndrome

Study Description
Brief Summary:
Men diagnosed with metabolic syndrome (MetS) consisting of 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 Not Applicable

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: The outcomes assessor will receive pseudonymized data
Primary Purpose: Health Services Research
Official Title: Fertility and Cardiovascular Risk in Men With Metabolic Syndrome
Estimated Study Start Date : September 1, 2019
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 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 [ Time Frame: 1 year ]
    Diabetes risk Glycated hemoglobin >5.7%, Cardiovascular risk: PROCAM score >5%, Hypogonadism score increase of 20 points


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Males diagnosed with metabolic syndrome
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Thomas Linn, MD +49 641 985 57017 thomas.linn@innere.med.uni-giessen.de

Sponsors and Collaborators
University of Giessen
Tracking Information
First Submitted Date  ICMJE June 4, 2019
First Posted Date  ICMJE June 6, 2019
Last Update Posted Date June 6, 2019
Estimated Study Start Date  ICMJE September 1, 2019
Estimated Primary Completion Date December 31, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 4, 2019) 		Number of participants with normalisation of diabetes or cardiovascular risk or improvement of hypogonadism [ Time Frame: 1 year ]
Diabetes risk Glycated hemoglobin >5.7%, Cardiovascular risk: PROCAM score >5%, Hypogonadism score increase of 20 points
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Fertility and Cardiovascular Risk in Men With Metabolic Syndrome
Official Title  ICMJE Fertility and Cardiovascular Risk in Men With Metabolic Syndrome
Brief Summary Men diagnosed with metabolic syndrome (MetS) consisting of 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 Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description:
The outcomes assessor will receive pseudonymized data
Primary Purpose: Health Services Research
Condition  ICMJE Metabolic Syndrome
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Life style change and weight reduction
  • No Intervention: Standard treatment group
    Patients will be taken care of by general physician without lifestyle program.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: June 4, 2019) 		70
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2024
Estimated Primary Completion Date December 31, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Gender Based Eligibility: Yes
Gender Eligibility Description: Males diagnosed with metabolic syndrome
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Thomas Linn, MD +49 641 985 57017 thomas.linn@innere.med.uni-giessen.de
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03977064
Other Study ID Numbers  ICMJE EK205/16
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of Giessen
Study Sponsor  ICMJE University of Giessen
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Giessen
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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