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

NCT03982238 | Completed Phase 4

• 1 other identifier: KY20190530-12
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• total testosterone levels

  changes of total testosterone levels

  1 month

Secondary Outcomes (2)

• bioavailable testosterone

  1 month

• free testosterone

  1 month

Study Arms (3)

Control group

ACTIVE COMPARATOR

continuous subcutaneous insulin infusion therapy

Drug: Insulin

Metformin

EXPERIMENTAL

metformin therapy

Drug: Metformin

Dapagliflozin

EXPERIMENTAL

Dapagliflozin

Drug: Dapagliflozin

Interventions

Insulin DRUG

Continuous subcutaneous insulin infusion therapy for 1 month

Control group

Metformin DRUG

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

Metformin

Dapagliflozin DRUG

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

Dapagliflozin

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Majianhua: lead

Study Sites (1)

Nanjing First Hospital

Nanjing, China

Location

Related Publications (1)

• 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.

  PMID: 33536253 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Insulin; Metformin; dapagliflozin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Biguanides; Guanidines; Amidines; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, Head of Endocrinology department, Clinical Professor

Study Record Dates

• First Submitted: June 9, 2019
• First Posted: June 11, 2019
• Study Start: June 15, 2019
• Primary Completion: November 15, 2019
• Study Completion: December 31, 2019
• Last Updated: April 3, 2020

Record last verified: 2019-06

Locations

CN (1)