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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

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.

Condition or disease Intervention/treatment
Type 2 Diabetes Mellitus in Obese Drug: Exenatide 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.

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Study Type : Observational
Actual Enrollment : 38 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: The Effect of Exenatide on Fasting Bile Acids in Newly Diagnosed Type 2 Diabetes Mellitus Patients, a Pilot Study
Actual Study Start Date : January 5, 2020
Actual Primary Completion Date : January 28, 2020
Actual Study Completion Date : January 31, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Exenatide

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 Name: exenatide




Primary Outcome Measures :
  1. Plasma total bile acids in fasting state [ Time Frame: 12 weeks ]
    reported in μmol/L


Secondary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Chinese population
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04303819


Locations
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China
Beijing Chao-yang hospital
Beijing, China, 100020
Sponsors and Collaborators
Beijing Chao Yang Hospital
Investigators
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Principal Investigator: Boyu Li, PHD Beijing Chao Yang Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Lihong Liu, professor, Beijing Chao Yang Hospital
ClinicalTrials.gov Identifier: NCT04303819    
Other Study ID Numbers: 20131212
First Posted: March 11, 2020    Key Record Dates
Last Update Posted: June 11, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Exenatide
Hypoglycemic Agents
Physiological Effects of Drugs
Anti-Obesity Agents
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists