NCT03437109

Brief Summary

The purpose of the study is to get data of prevalence of testosterone deficiency in patient with T2DM in Russian Federation

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
554

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2017

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 6, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 13, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 19, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2019

Completed
Last Updated

June 20, 2019

Status Verified

January 1, 2019

Enrollment Period

1.2 years

First QC Date

February 13, 2018

Last Update Submit

June 19, 2019

Conditions

T2DM (Type 2 Diabetes Mellitus)Hypogonadism

Outcome Measures

Primary Outcomes (1)

  • The prevalence of hypogonadism in patients with T2DM

    The prevalence of hypogonadism in patients with T2DM

    2017-2018

Interventions

Laboratory testsDIAGNOSTIC_TEST

Testosterone HSBG Hb1Ac LH

Eligibility Criteria

Age45 Years - 60 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Men with T2DM aged between 45-60 years old

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

ENC

Moscow, 117036, Russia

Location

Central Clinical Hospital

Moscow, 121359, Russia

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Hypogonadism

Interventions

Clinical Laboratory Techniques

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesGonadal Disorders

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Officials

  • Marina SHESTAKOVA, academitian

    ENC

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2018

First Posted

February 19, 2018

Study Start

December 6, 2017

Primary Completion

February 1, 2019

Study Completion

February 1, 2019

Last Updated

June 20, 2019

Record last verified: 2019-01

Locations

RU(2)