The Correlation Between Testosterone and Cortisol Level and Inflammatory Markers Levels in Type 2 Diabetic Men.

NCT ID: NCT02529306

Last Updated: 2018-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-09-01

Study Completion Date

2019-09-30

Brief Summary

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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.

Detailed Description

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Eligible participants are type 2 diabetic men who visit our clinic, as part of their routine medical surveillance, and other 10 healthy volunteers (men) as a control group.

All the participants will sign an informed consent form. The study will include 30 type 2 diabetic men, (40-55 years old) and 10 healthily volunteers (same age group).

In addition to routine blood test of blood count, kidney function and liver enzymes will be taken blood samples of total testosterone serum levels, total cortisol serum levels and serum inflammation markers levels, and also a sample of head-hair for cortisol and testosterone levels (1 cm of occipital hair weighing 50 mg).

Optional: from patients who will agree to visit the clinic after 8 hours-fast will be also taken one additional blood sample of fasting glucose, insulin and C-peptide levels, in order to estimate their insulin resistance status, and it's possible correlation to the other measures.

From the 10 healthy volunteers In addition will be taken blood and hair samples of the above parameters, as a control.

Conditions

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Type 2 Diabetic

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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two parallel group

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

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* men age 40-55
* type 2 diabetic

Exclusion Criteria

* HIV
* septic disease
Minimum Eligible Age

40 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Bnai Zion Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Haifa, , Israel

Site Status RECRUITING

Countries

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Israel

Facility Contacts

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Julia Sterlin

Role: primary

97248359281

Other Identifiers

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0045-15BNZ

Identifier Type: -

Identifier Source: org_study_id

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