The Effect of Exenatide on Fasting Bile Acids | NCT04303819

Studies
The Effect of Exenatide on Fasting Bile Acids

NCT04303819

Sponsor

Beijing Chao Yang Hospital

Status

Completed

Last Update Posted

Jun 11, 2020Actual

Enrollment

38Actual

Phase

Not provided

Conditions

Type 2 Diabetes Mellitus in Obese

Interventions

Exenatide treatment

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 5, 2020Actual

Primary Completion Date

Jan 28, 2020Actual

Completion Date

Jan 31, 2020Actual

First Submitted Date

Mar 4, 2020

First Submission Date that Met QC Criteria

Mar 9, 2020

First Posted Date

Mar 11, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 8, 2020

Last Update Posted Date

Jun 11, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

38Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
newly diagnosed T2DM participants		newly diagnosed T2DM participants without anti-diabetic drugs intake	Drug: Exenatide treatment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Plasma total bile acids in fasting state	reported in μmol/L	12 weeks

Secondary Outcomes

Measure	Description	Time Frame
fasting plasma glucose	reported in mmol/L	12 weeks
Glycated hemoglobin A1c	reported in %	12 weeks

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Chinese population

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Boyu Li, PHD	Beijing Chao Yang Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Beijing Chao-yang hospital		Beijing		100020	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32539783	Derived	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.

ID	Term
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins
D014688	Venoms
D045424	Complex Mixtures