NCT02529306

Brief Summary

Many type 2 diabetic men have low serum testosterone levels. Our aim in this trial is to check if there is a correlation between serum or hair testosteron levels and serum or hair cortisol levels in type 2 diabetic men. We'll also examine whether there is a correlation between serum and hair testosterone levels and cortisol levels and serum inflammatory markers. If such correlation will be found- then it is possible that excess cortisol or an abnormal inflammatory status- may cause the low testosterone levels that seen in type 2 diabetic men.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 29, 2015

Completed
22 days until next milestone

First Posted

Study publicly available on registry

August 20, 2015

Completed
12 days until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

August 14, 2018

Status Verified

August 1, 2018

Enrollment Period

4 years

First QC Date

July 29, 2015

Last Update Submit

August 12, 2018

Conditions

Type 2 Diabetic

Keywords

men

Outcome Measures

Primary Outcomes (4)

  • Testosterone level

    single blood and hair sample will be drawn to measure Testosterone levels (nmol/L)

    24 months

  • Cortisol level

    single blood and hair sample will be drawn to measure cortisol levels (mcg/dl)

    24 months

  • C-reactive protein levels

    single blood sample will be drawn to measure c-reactive protein levels (mcg/dl)

    24 months

  • Anti Tumor Necrosis Factor alpha

    single blood sample will be drawn to measure Anti Tumor Necrosis Factor alpha levels (pg/ml)

    24 months

Study Arms (1)

two parallel group

group with inflammatory markers high levels and control group with inflammatory normal levels markers.

Eligibility Criteria

Age40 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Type 2 diabetic men, age 40-55

You may qualify if:

  • men age 40-55
  • type 2 diabetic

You may not qualify if:

  • HIV
  • septic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Haifa, Israel

RECRUITING

MeSH Terms

Conditions

Multiple Endocrine Neoplasia Type 1

Condition Hierarchy (Ancestors)

Multiple Endocrine NeoplasiaEndocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsNeoplasms, Multiple PrimaryNeoplastic Syndromes, HereditaryGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesEndocrine System Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 29, 2015

First Posted

August 20, 2015

Study Start

September 1, 2015

Primary Completion

September 1, 2019

Study Completion

September 1, 2019

Last Updated

August 14, 2018

Record last verified: 2018-08

Locations

IL(1)