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

Study Overview
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Brief Summary
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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.

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

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Drug: Insulin
* Drug: Metformin
* Drug: Dapagliflozin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control group<br>continuous subcutaneous insulin infusion therapy | Drug: Insulin<br>* Continuous subcutaneous insulin infusion therapy for 1 month<br>|
| Experimental: Metformin<br>metformin therapy | Drug: Metformin<br>* Continuous subcutaneous insulin infusion plus metformin (at least1000mg/day) for 1 month<br>|
| Experimental: Dapagliflozin<br>Dapagliflozin | Drug: Dapagliflozin<br>* Continuous subcutaneous insulin infusion plus metformin (10mg/day) for 1 month<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| total testosterone levels | changes of total testosterone levels | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bioavailable testosterone | changes of bioavailable testosterone | 1 month | 
| free testosterone | changes of free testosterone | 1 month |