The Effect of Exenatide on Fasting Bile Acids

June 8, 2020 updated by: Lihong Liu, Beijing Chao Yang Hospital

The Effect of Exenatide on Fasting Bile Acids in Newly Diagnosed Type 2 Diabetes Mellitus Patients, a Pilot Study

Newly diagnosed T2DM participants without hypoglycemic drugs intake were retrospective analyzed. Plasma total bile acids in fasting state (FTBAs) and other parameters were compared before and after exenatide treatment and correlation analysis between changes of FTBAs and glycemic parameters.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Newly diagnosed T2DM participants without hypoglycemic drugs intake were retrospective analyzed. Plasma total bile acids in fasting state (FTBAs) and other parameters were tested at baseline. Then exenatide were applied to the T2DM participants for 12 weeks. FTBAs and glycemic parameters were measured again after exenatide treatment, and correlation analysis between changes of FTBAs and glycemic parameters were conducted to investigate the role of BAs in the glycemic control effect of exenatide.

Study Type

Observational

Enrollment (Actual)

38

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

  • China
      • Beijing, China, 100020
        • Beijing Chao-Yang 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 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Chinese population

Description

Inclusion Criteria:

  • Newly diagnosed T2DM patients

Exclusion Criteria:

  • History of hepatobiliary or pancreatic diseases
  • History of anti-diabetic drugs intake
  • Change of anti-dyslipidemia therapy regimen
  • Estimated glomerular filtration rate less than 60 mL/min/1.73 m^2
  • Pregnancy

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
newly diagnosed T2DM participants
newly diagnosed T2DM participants without anti-diabetic drugs intake
Drug: Exenatide treatment
12 weeks of exenatide injection, 5 μg twice a day by subcutaneous injection for 4 weeks, followed by 10 μg twice a day for 8 weeks, as recommended by the drug manufacturer.
Other Names:
  • exenatide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plasma total bile acids in fasting state
Time Frame: 12 weeks
reported in μmol/L
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
fasting plasma glucose
Time Frame: 12 weeks
reported in mmol/L
12 weeks
Glycated hemoglobin A1c
Time Frame: 12 weeks
reported in %
12 weeks
C-peptide
Time Frame: 12 weeks
reported in mU/L
12 weeks
Fasting serum insulin
Time Frame: 12 weeks
reported in mU/L
12 weeks
Body mess index
Time Frame: 12 weeks
reported in kg/m^2
12 weeks

Collaborators and Investigators

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

Sponsor

Beijing Chao Yang Hospital

Investigators

  • Principal Investigator: Boyu Li, PHD, Beijing Chao Yang Hospital

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.

General Publications

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)

January 5, 2020

Primary Completion (ACTUAL)

January 28, 2020

Study Completion (ACTUAL)

January 31, 2020

Study Registration Dates

First Submitted

March 4, 2020

First Submitted That Met QC Criteria

March 9, 2020

First Posted (ACTUAL)

March 11, 2020

Study Record Updates

Last Update Posted (ACTUAL)

June 11, 2020

Last Update Submitted That Met QC Criteria

June 8, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20131212

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

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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