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The Effect of Exenatide on Fasting Bile Acids

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04303819
Enrollment
38
Registered
2020-03-11
Start date
2020-01-05
Completion date
2020-01-31
Last updated
2020-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus in Obese

Brief summary

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.

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.

Interventions

DRUGExenatide 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.

Sponsors

Beijing Chao Yang Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Plasma total bile acids in fasting state12 weeksreported in μmol/L

Secondary

MeasureTime frameDescription
fasting plasma glucose12 weeksreported in mmol/L
Glycated hemoglobin A1c12 weeksreported in %
C-peptide12 weeksreported in mU/L
Fasting serum insulin12 weeksreported in mU/L
Body mess index12 weeksreported in kg/m\^2

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026