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NCT Number: NCT03982238

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

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.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Nanjing First Hospital

Nanjing, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Insulin

Drug

Continuous subcutaneous insulin infusion therapy for 1 month

metformin

Drug

Continuous subcutaneous insulin infusion plus metformin (at least1000mg/day) for 1 month

Dapagliflozin

Drug

Continuous subcutaneous insulin infusion plus metformin (10mg/day) for 1 month

Primary outcomes

  1. total testosterone levels

    Time frame: 1 month

    changes of total testosterone levels

Secondary outcomes

  1. bioavailable testosterone

    Time frame: 1 month

    changes of bioavailable testosterone

  2. free testosterone

    Time frame: 1 month

    changes of free testosterone

Sponsors and collaborators

Lead sponsor

Majianhua

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jun 11, 2019
Registry last updated
Apr 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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