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Trial record 4 of 79 for:    the effect of exenatide

The Effect of Exenatide on Fasting Bile Acids

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04303819
Recruitment Status : Completed
First Posted : March 11, 2020
Last Update Posted : June 11, 2020
Sponsor:
Information provided by (Responsible Party):
Lihong Liu, Beijing Chao Yang Hospital

Tracking Information
First Submitted Date March 4, 2020
First Posted Date March 11, 2020
Last Update Posted Date June 11, 2020
Actual Study Start Date January 5, 2020
Actual Primary Completion Date January 28, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 9, 2020)
Plasma total bile acids in fasting state [ Time Frame: 12 weeks ]
reported in μmol/L
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: March 9, 2020)
  • fasting plasma glucose [ Time Frame: 12 weeks ]
    reported in mmol/L
  • Glycated hemoglobin A1c [ Time Frame: 12 weeks ]
    reported in %
  • C-peptide [ Time Frame: 12 weeks ]
    reported in mU/L
  • Fasting serum insulin [ Time Frame: 12 weeks ]
    reported in mU/L
  • Body mess index [ Time Frame: 12 weeks ]
    reported in kg/m^2
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Effect of Exenatide on Fasting Bile Acids
Official Title The Effect of Exenatide on Fasting Bile Acids in Newly Diagnosed Type 2 Diabetes Mellitus Patients, a Pilot Study
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Chinese population
Condition 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.
Other Name: exenatide
Study Groups/Cohorts newly diagnosed T2DM participants
newly diagnosed T2DM participants without anti-diabetic drugs intake
Intervention: Drug: Exenatide treatment
Publications * Li B, Hu Y, Wang G, Liu L. The effect of exenatide on fasting bile acids in newly diagnosed type 2 diabetes mellitus patients, a pilot study. BMC Pharmacol Toxicol. 2020 Jun 15;21(1):44. doi: 10.1186/s40360-020-00422-5.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 8, 2020)
38
Original Estimated Enrollment
 (submitted: March 9, 2020)
40
Actual Study Completion Date January 31, 2020
Actual Primary Completion Date January 28, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT04303819
Other Study ID Numbers 20131212
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Lihong Liu, Beijing Chao Yang Hospital
Study Sponsor Beijing Chao Yang Hospital
Collaborators Not Provided
Investigators
Principal Investigator: Boyu Li, PHD Beijing Chao Yang Hospital
PRS Account Beijing Chao Yang Hospital
Verification Date June 2020