Effects of Hypoglycemic Drugs on Testosterone Levels in T... | NCT03982238

Studies
Effects of Hypoglycemic Drugs on Testosterone Levels in Type 2 Diabetes Patients

NCT03982238

Sponsor

Majianhua

Status

Completed

Last Update Posted

Apr 3, 2020Actual

Enrollment

74Actual

Phase

Phase 4

Conditions

Type 2 Diabetes

Interventions

Insulin
Metformin
Dapagliflozin

Countries

China

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

Jun 2019

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

Jun 15, 2019Actual

Primary Completion Date

Nov 15, 2019Actual

Completion Date

Dec 31, 2019Actual

First Submitted Date

Jun 9, 2019

First Submission Date that Met QC Criteria

Jun 9, 2019

First Posted Date

Jun 11, 2019Actual

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

Apr 1, 2020

Last Update Posted Date

Apr 3, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Majianhua, Director, Head of Endocrinology department, Clinical Professor, Nanjing First Hospital, Nanjing Medical UniversitySponsor-Investigator

Lead Sponsor

MajianhuaOTHER

Collaborators

Not provided

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

The study will assess the total testosterone and sex hormone-binding globulin levels in men with type 2 diabetes before and after continuous subcutaneous insulin infusion and hypoglycemic drugs treatment.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

74Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control group	Active Comparator	continuous subcutaneous insulin infusion therapy	Drug: Insulin
Metformin	Experimental	metformin therapy	Drug: Metformin
Dapagliflozin	Experimental	Dapagliflozin	Drug: Dapagliflozin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Insulin	Drug	Continuous subcutaneous insulin infusion therapy for 1 month	Control group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
total testosterone levels	changes of total testosterone levels	1 month

Secondary Outcomes

Measure	Description	Time Frame
bioavailable testosterone	changes of bioavailable testosterone	1 month
free testosterone	changes of free testosterone	1 month

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

volunteer to participate and be able to sign informed consent prior to the trial.
patients with type 2 diabetes, aged 18-60 years old, meeting WHO1999 diagnostic criteria, have not used any hypoglycemic drugs.
HbA1c > 9%.
subjects are able and willing to eat and exercise regularly.

Exclusion Criteria:

patients with insulin allergy.
impaired liver and kidney function with ALT 2.5 times higher than the upper limit of normal value;Serum creatinine was 1.3 times higher than the upper limit of normal.● drug abuse and alcohol dependence in the past 5 years.
systemic hormone therapy was used in the last three months.
patients with poor compliance and irregular diet and exercise.
patients with infection and stress within 4 weeks.
any other obvious conditions or associated diseases determined by the researcher: such as severe cardiopulmonary diseases, endocrine diseases, neurological diseases, tumors and other diseases, other pancreatic diseases, history of mental diseases.

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33536253	Derived	Hu Y, Ding B, Shen Y, Yan RN, Li FF, Sun R, Jing T, Lee KO, Ma JH. Rapid Changes in Serum Testosterone in Men With Newly Diagnosed Type 2 Diabetes With Intensive Insulin and Metformin. Diabetes Care. 2021 Apr;44(4):1059-1061. doi: 10.2337/dc20-1558. Epub 2021 Feb 3.

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

ID	Term
D007328	Insulin
D008687	Metformin
C529054	dapagliflozin

ID	Term
D011384	Proinsulin
D061385	Insulins
D010187	Pancreatic Hormones
D036361	Peptide Hormones