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NCT Number: NCT03519529

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).

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Key information

Conditions

Type2 Diabetes

Sex eligibility

Male

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. sex hormone-binding globulin

    Time frame: Day 1

    the blood sex hormone-binding globulin level of patients

Secondary outcomes

  1. Testosterone

    Time frame: Day 1

    blood testosterone level of patients

  2. EPO

    Time frame: Day 1

    blood erythropoietin level of patients

  3. HbA1c

    Time frame: Day 1

    the glycosylated hemoglobin level of patients

  4. MBG

    Time frame: Day 1-4

    24h mean blood glucose tested by CGM

  5. MAGE

    Time frame: Day 1-4

    the 24h mean amplitude of glycemic excursion

  6. SD

    Time frame: Day 1-4

    the standard deviation of mean glucose

Sponsors and collaborators

Lead sponsor

Nanjing First Hospital, Nanjing Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
May 9, 2018
Registry last updated
May 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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