Sex Hormone Binding Globulin, Testosterone and Glycemic C... | NCT03519529

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

NCT03519529

Sponsor

Nanjing First Hospital, Nanjing Medical University

Status

Completed

Last Update Posted

May 11, 2018Actual

Enrollment

250Actual

Phase

Not provided

Conditions

Type2 Diabetes

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2015Actual

Primary Completion Date

Apr 15, 2018Actual

Completion Date

Apr 20, 2018Actual

First Submitted Date

Apr 26, 2018

First Submission Date that Met QC Criteria

Apr 26, 2018

First Posted Date

May 9, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 8, 2018

Last Update Posted Date

May 11, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

250Actual

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Testosterone	blood testosterone level of patients	Day 1
EPO	blood erythropoietin level of patients	Day 1

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

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.

Sampling Method

Non-Probability Sample

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
30614187	Derived	Ding B, Sun R, Zhai XF, Lu TT, Cheng L, Li FF, Hu Y, Ma JH. Association of high circulating testosterone with increased glycaemic variability in type 2 diabetes: A cross-sectional study in China. Diabetes Metab Res Rev. 2019 May;35(4):e3126. doi: 10.1002/dmrr.3126. Epub 2019 Jan 23.