Sex Hormone Binding Globulin, Testosterone and Glycemic Control in Patients With Type 2 Diabetes

May 8, 2018 updated by: Nanjing First Hospital, Nanjing Medical University

The Relationship Between Sex Hormone Binding Globulin, Testosterone and Glycemic Control in Patients With Type 2 Diabetes

Sex hormone-binding globulin(SHBG) is a surrogate marker of insulin resistance. This study aims at the characteristic and clinical significance of SHBG and testosterone in patients with type 2 diabetes(T2D).

Study Overview

Status

Completed

Conditions

Detailed Description

The investigators recorded clinical factors, biochemical criterion such as serum levels of glucose and lipids, HbA1c, SHBG, testosterone, insulin, EPO, C-peptide, glucagon, microalbuminuria, glycemic variation via CGM, carotid plaque, ECG and ultrasonic cardiogram in patients with T2D who visited in the Department of Endocrinology at the Nanjing First Hospital from January 2015 to Aprol 2018. The relationship between levels of SHBG, testosterone and glycemic variation/diabetic complications are analysed.

Study Type

Observational

Enrollment (Actual)

250

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Patients with type 2 diabetes who visited in the Department of Endocrinology at the Nanjing First Hospital from January 2015 to April 2018 were enrolled in this study.

Description

Inclusion Criteria:

● Patients with T2D and the diagnostic criteria of T2D is according to the World Health Organization in 1999.

Exclusion Criteria:

  • Patients use systemic steroidal anti-inflammatory drugs.
  • Patients with an acute infection.
  • Patients with acute complication of diabetes.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
sex hormone-binding globulin
Time Frame: Day 1
the blood sex hormone-binding globulin level of patients
Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Testosterone
Time Frame: Day 1
blood testosterone level of patients
Day 1
EPO
Time Frame: Day 1
blood erythropoietin level of patients
Day 1
HbA1c
Time Frame: Day 1
the glycosylated hemoglobin level of patients
Day 1
MBG
Time Frame: Day 1-4
24h mean blood glucose tested by CGM
Day 1-4
MAGE
Time Frame: Day 1-4
the 24h mean amplitude of glycemic excursion
Day 1-4
SD
Time Frame: Day 1-4
the standard deviation of mean glucose
Day 1-4

Collaborators and Investigators

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

Sponsor

Nanjing First Hospital, Nanjing Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

January 1, 2015

Primary Completion (Actual)

April 15, 2018

Study Completion (Actual)

April 20, 2018

Study Registration Dates

First Submitted

April 26, 2018

First Submitted That Met QC Criteria

April 26, 2018

First Posted (Actual)

May 9, 2018

Study Record Updates

Last Update Posted (Actual)

May 11, 2018

Last Update Submitted That Met QC Criteria

May 8, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ENDO20180426-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Clinical Trials on Type2 Diabetes

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Switzerland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe