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

August 12, 2018 updated by: Bnai Zion Medical Center

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

Unknown

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

Observational

Enrollment (Anticipated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Type 2 diabetic men, age 40-55

Description

Inclusion Criteria:

  • men age 40-55
  • type 2 diabetic

Exclusion Criteria:

  • HIV
  • septic disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Testosterone level
Time Frame: 24 months
single blood and hair sample will be drawn to measure Testosterone levels (nmol/L)
24 months
Cortisol level
Time Frame: 24 months
single blood and hair sample will be drawn to measure cortisol levels (mcg/dl)
24 months
C-reactive protein levels
Time Frame: 24 months
single blood sample will be drawn to measure c-reactive protein levels (mcg/dl)
24 months
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)
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bnai Zion Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2015

Primary Completion (Anticipated)

September 1, 2019

Study Completion (Anticipated)

September 1, 2019

Study Registration Dates

First Submitted

July 29, 2015

First Submitted That Met QC Criteria

August 19, 2015

First Posted (Estimate)

August 20, 2015

Study Record Updates

Last Update Posted (Actual)

August 14, 2018

Last Update Submitted That Met QC Criteria

August 12, 2018

Last Verified

August 1, 2018

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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