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

April 1, 2020 updated by: Majianhua

Effects of Continuous Subcutaneous Insulin Infusion and Oral 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.

Study Overview

Status

Completed

Conditions

Study Type

Interventional

Enrollment (Actual)

74

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Nanjing, China
        • Nanjing First Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 15, 2019

Primary Completion (Actual)

November 15, 2019

Study Completion (Actual)

December 31, 2019

Study Registration Dates

First Submitted

June 9, 2019

First Submitted That Met QC Criteria

June 9, 2019

First Posted (Actual)

June 11, 2019

Study Record Updates

Last Update Posted (Actual)

April 3, 2020

Last Update Submitted That Met QC Criteria

April 1, 2020

Last Verified

June 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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