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Completed

NCT Number: NCT04303819

The Effect of Exenatide on Fasting Bile Acids

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.

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Key information

Conditions

Type 2 Diabetes Mellitus in Obese

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Beijing Chao-yang hospital

Beijing, 100020, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Exenatide treatment

Drug

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

Primary outcomes

  1. Plasma total bile acids in fasting state

    Time frame: 12 weeks

    reported in μmol/L

Secondary outcomes

  1. fasting plasma glucose

    Time frame: 12 weeks

    reported in mmol/L

  2. Glycated hemoglobin A1c

    Time frame: 12 weeks

    reported in %

  3. C-peptide

    Time frame: 12 weeks

    reported in mU/L

  4. Fasting serum insulin

    Time frame: 12 weeks

    reported in mU/L

  5. Body mess index

    Time frame: 12 weeks

    reported in kg/m^2

Sponsors and collaborators

Lead sponsor

Beijing Chao Yang Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Mar 11, 2020
Registry last updated
Jun 11, 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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