- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02529306
The Correlation Between Testosterone and Cortisol Level and Inflammatory Markers Levels in Type 2 Diabetic Men. (BZMC)
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.
Study Overview
Status
Conditions
Detailed 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.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Haifa, Israel
- Recruiting
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Contact:
- Julia Sterlin
- Phone Number: 97248359281
- Email: julia.sterlin@gmail.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- men age 40-55
- type 2 diabetic
Exclusion Criteria:
- HIV
- septic disease
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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two parallel group
group with inflammatory markers high levels and control group with inflammatory normal levels markers.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Testosterone level
Time Frame: 24 months
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single blood and hair sample will be drawn to measure Testosterone levels (nmol/L)
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24 months
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Cortisol level
Time Frame: 24 months
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single blood and hair sample will be drawn to measure cortisol levels (mcg/dl)
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24 months
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C-reactive protein levels
Time Frame: 24 months
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single blood sample will be drawn to measure c-reactive protein levels (mcg/dl)
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24 months
|
Anti Tumor Necrosis Factor alpha
Time Frame: 24 months
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single blood sample will be drawn to measure Anti Tumor Necrosis Factor alpha levels (pg/ml)
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24 months
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 0045-15BNZ
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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