The Effect of Exenatide on Fasting Bile Acids

Type 2 Diabetes Mellitus in Obese Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04303819
• Other study ID #: 20131212
• Status: Completed
• Start date: January 5, 2020
• Est. completion date: January 31, 2020

Study information

• Verified date: June 2020
• Source: Beijing Chao Yang Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: January 31, 2020
• Est. primary completion date: January 28, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus in Obese

Intervention

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.

Locations

Country	Name	City	State
China	Beijing Chao-yang hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Chao Yang Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma total bile acids in fasting state	reported in µmol/L	12 weeks
Secondary	fasting plasma glucose	reported in mmol/L	12 weeks
Secondary	Glycated hemoglobin A1c	reported in %	12 weeks
Secondary	C-peptide	reported in mU/L	12 weeks
Secondary	Fasting serum insulin	reported in mU/L	12 weeks
Secondary	Body mess index	reported in kg/m^2	12 weeks