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

Type 2 Diabetes Clinical Trial

Official title:

Effects of Continuous Subcutaneous Insulin Infusion and Oral Hypoglycemic Drugs on Testosterone Levels in Type 2 Diabetes Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03982238
• Other study ID #: KY20190530-12
• Status: Completed
• Phase: Phase 4
• Start date: June 15, 2019
• Est. completion date: December 31, 2019

Study information

• Verified date: June 2019
• Source: Nanjing First Hospital, Nanjing Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: December 31, 2019
• Est. primary completion date: November 15, 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• Insulin
Continuous subcutaneous insulin infusion therapy for 1 month
• Metformin
Continuous subcutaneous insulin infusion plus metformin (at least1000mg/day) for 1 month
• Dapagliflozin
Continuous subcutaneous insulin infusion plus metformin (10mg/day) for 1 month

Locations

Country	Name	City	State
China	Nanjing First Hospital	Nanjing

Sponsors (1)

Lead Sponsor	Collaborator
Majianhua

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	total testosterone levels	changes of total testosterone levels	1 month
Secondary	bioavailable testosterone	changes of bioavailable testosterone	1 month
Secondary	free testosterone	changes of free testosterone	1 month