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Efficacy of Androgen Substitution for Hypogonadism in Men With Type 2 Diabetes Mellitus (DESTINY)

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ClinicalTrials.gov Identifier: NCT03437109
Recruitment Status : Completed
First Posted : February 19, 2018
Last Update Posted : June 20, 2019
Sponsor:
Information provided by (Responsible Party):
Besins Healthcare

Study Description
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Brief Summary:
The purpose of the study is to get data of prevalence of testosterone deficiency in patient with T2DM in Russian Federation

Condition or disease Intervention/treatment
T2DM (Type 2 Diabetes Mellitus) Hypogonadism Diagnostic Test: Laboratory tests

Detailed Description:
Clinical and Epidemiological Characteristics and Efficacy of Androgen Substitution for Hypogonadism in Men With Type 2 Diabetes Mellitus Under Routine Clinical Practice (DESTINY)
Study Design
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Study Type : Observational
Actual Enrollment : 554 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical and Epidemiological Characteristics and Efficacy of Androgen Substitution for Hypogonadism in Men With Type 2 Diabetes Mellitus Under Routine Clinical Practice
Actual Study Start Date : December 6, 2017
Actual Primary Completion Date : February 1, 2019
Actual Study Completion Date : February 1, 2019

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Groups and Cohorts
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Intervention Details:
  • Diagnostic Test: Laboratory tests
    Testosterone HSBG Hb1Ac LH

Outcome Measures
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Primary Outcome Measures :
  1. The prevalence of hypogonadism in patients with T2DM [ Time Frame: 2017-2018 ]
    The prevalence of hypogonadism in patients with T2DM


Eligibility Criteria
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Ages Eligible for Study:   45 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Men with T2DM aged between 45-60 years old
Criteria

Inclusion Criteria:

  • Male 45-60 years old
  • Diagnosis of T2DM according to approved standards
  • Signed Informed Consent Form

Exclusion Criteria:

  • Prepubertal hypogonadism of any genesis;
  • Sexual and developmental disorders;
  • Absence of at least one of the testicles;
  • Cryptorchidism, including in the anamnesis;
  • Injuries and / or surgical interventions on the genitals with loss of at least one of the testicles;
  • Established diagnosis of panhypopituitarism in accordance with current recommendations / standards;
  • Androgen therapy, administered at the time of the study or in the anamnesis;
  • Admission of anabolic steroids;
  • Alcoholism or drug addiction;
  • Insolvency.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03437109


Locations
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Russian Federation
ENC
Moscow, Russian Federation, 117036
Central Clinical Hospital
Moscow, Russian Federation, 121359
Sponsors and Collaborators
Besins Healthcare
Investigators
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Study Chair: Marina SHESTAKOVA, academitian ENC
More Information
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Responsible Party: Besins Healthcare
ClinicalTrials.gov Identifier: NCT03437109    
Other Study ID Numbers: BH-DM-11-2017
First Posted: February 19, 2018    Key Record Dates
Last Update Posted: June 20, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Hypogonadism
Glucose Metabolism Disorders
 Metabolic Diseases
Endocrine System Diseases
Gonadal Disorders