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

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ClinicalTrials.gov Identifier: NCT02529306
Recruitment Status : Recruiting
First Posted : August 20, 2015
Last Update Posted : August 14, 2018
Sponsor:
Information provided by (Responsible Party):
Bnai Zion Medical Center

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.


Condition or disease
Type 2 Diabetic

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.


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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: The Correlation Between Testosterone and Cortisol Level and Inflammatory Markers Levels in Type 2 Diabetic Men.
Actual Study Start Date : September 1, 2015
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019

Group/Cohort
two parallel group
group with inflammatory markers high levels and control group with inflammatory normal levels markers.



Primary Outcome Measures :
  1. Testosterone level [ Time Frame: 24 months ]
    single blood and hair sample will be drawn to measure Testosterone levels (nmol/L)

  2. Cortisol level [ Time Frame: 24 months ]
    single blood and hair sample will be drawn to measure cortisol levels (mcg/dl)

  3. C-reactive protein levels [ Time Frame: 24 months ]
    single blood sample will be drawn to measure c-reactive protein levels (mcg/dl)

  4. Anti Tumor Necrosis Factor alpha [ Time Frame: 24 months ]
    single blood sample will be drawn to measure Anti Tumor Necrosis Factor alpha levels (pg/ml)



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Ages Eligible for Study:   40 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Type 2 diabetic men, age 40-55
Criteria

Inclusion Criteria:

  • men age 40-55
  • type 2 diabetic

Exclusion Criteria:

  • HIV
  • septic disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02529306


Locations
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Israel
Recruiting
Haifa, Israel
Contact: Julia Sterlin    97248359281    julia.sterlin@gmail.com   
Sponsors and Collaborators
Bnai Zion Medical Center

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Responsible Party: Bnai Zion Medical Center
ClinicalTrials.gov Identifier: NCT02529306     History of Changes
Other Study ID Numbers: 0045-15BNZ
First Posted: August 20, 2015    Key Record Dates
Last Update Posted: August 14, 2018
Last Verified: August 2018

Keywords provided by Bnai Zion Medical Center:
men

Additional relevant MeSH terms:
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Testosterone
Testosterone undecanoate
Testosterone enanthate
Testosterone 17 beta-cypionate
Methyltestosterone
Hydrocortisone
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents
Anti-Inflammatory Agents