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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03519529
Recruitment Status : Completed
First Posted : May 9, 2018
Last Update Posted : May 10, 2018
Information provided by (Responsible Party):
Nanjing First Hospital, Nanjing Medical University

Brief 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).

Condition or disease
Type2 Diabetes

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.

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Study Type : Observational
Actual Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: The Relationship Between Sex Hormone Binding Globulin, Testosterone and Glycemic Control in Patients With Type 2 Diabetes
Actual Study Start Date : January 1, 2015
Actual Primary Completion Date : April 15, 2018
Actual Study Completion Date : April 20, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones

Primary Outcome Measures :
  1. sex hormone-binding globulin [ Time Frame: Day 1 ]
    the blood sex hormone-binding globulin level of patients

Secondary Outcome Measures :
  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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.

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.

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Nanjing First Hospital, Nanjing Medical University Identifier: NCT03519529     History of Changes
Other Study ID Numbers: ENDO20180426-01
First Posted: May 9, 2018    Key Record Dates
Last Update Posted: May 10, 2018
Last Verified: April 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nanjing First Hospital, Nanjing Medical University:
sex hormone-binding globulin
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Testosterone undecanoate
Testosterone enanthate
Testosterone 17 beta-cypionate
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents