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

Phase 4

Completed

• Conditions: Type 2 Diabetes
• Interventions: Drug: Dapagliflozin; Drug: Insulin; Drug: Metformin

• Registration Number: NCT03982238
• Lead Sponsor: Majianhua

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 available

Study Timeline

• Status Verified: 2019-06
• Study First Submitted: 2019-06-09
• Study First Submitted QC: 2019-06-09
• Study First Posted: 2019-06-11
• Study Start: 2019-06-15
• Primary Completion: 2019-11-15
• Study Completion: 2019-12-31
• Last Update Submitted: 2020-04-01
• Last Update Posted: 2020-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 74

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dapagliflozin	Dapagliflozin	Dapagliflozin
Control group	Insulin	continuous subcutaneous insulin infusion therapy
Metformin	Metformin	metformin therapy

Primary Outcome Measures

Name	Time	Method
total testosterone levels	1 month	changes of total testosterone levels

Secondary Outcome Measures

Name	Time	Method
bioavailable testosterone	1 month	changes of bioavailable testosterone
free testosterone	1 month	changes of free testosterone

Trial Locations

Locations (1)

Nanjing First Hospital; 🇨🇳 Nanjing, China