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

Type 2 Diabetic Clinical Trial

— BZMC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02529306
• Other study ID #: 0045-15BNZ
• Status: Recruiting
• Start date: September 1, 2015
• Est. completion date: September 2019

Study information

• Verified date: August 2018
• Source: Bnai Zion Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: September 2019
• Est. primary completion date: September 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 40 Years to 55 Years

Eligibility

Inclusion Criteria:

• men age 40-55

• type 2 diabetic

Exclusion Criteria:

• HIV

• septic disease

Related Conditions & MeSH terms

• Type 2 Diabetic

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bnai Zion Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Testosterone level	single blood and hair sample will be drawn to measure Testosterone levels (nmol/L)	24 months
Primary	Cortisol level	single blood and hair sample will be drawn to measure cortisol levels (mcg/dl)	24 months
Primary	C-reactive protein levels	single blood sample will be drawn to measure c-reactive protein levels (mcg/dl)	24 months
Primary	Anti Tumor Necrosis Factor alpha	single blood sample will be drawn to measure Anti Tumor Necrosis Factor alpha levels (pg/ml)	24 months