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

Type2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03519529
• Other study ID #: ENDO20180426-01
• Status: Completed
• Start date: January 1, 2015
• Est. completion date: April 20, 2018

Study information

• Verified date: April 2018
• Source: Nanjing First Hospital, Nanjing Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: April 20, 2018
• Est. primary completion date: April 15, 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type2 Diabetes

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing First Hospital, Nanjing Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	sex hormone-binding globulin	the blood sex hormone-binding globulin level of patients	Day 1
Secondary	Testosterone	blood testosterone level of patients	Day 1
Secondary	EPO	blood erythropoietin level of patients	Day 1
Secondary	HbA1c	the glycosylated hemoglobin level of patients	Day 1
Secondary	MBG	24h mean blood glucose tested by CGM	Day 1-4
Secondary	MAGE	the 24h mean amplitude of glycemic excursion	Day 1-4
Secondary	SD	the standard deviation of mean glucose	Day 1-4