NCT04303819

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 5, 2020

Completed
23 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 28, 2020

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 4, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 11, 2020

Completed
Last Updated

June 11, 2020

Status Verified

June 1, 2020

Enrollment Period

23 days

First QC Date

March 4, 2020

Last Update Submit

June 8, 2020

Conditions

Type 2 Diabetes Mellitus in Obese

Outcome Measures

Primary Outcomes (1)

  • Plasma total bile acids in fasting state

    reported in μmol/L

    12 weeks

Secondary Outcomes (5)

  • fasting plasma glucose

    12 weeks

  • Glycated hemoglobin A1c

    12 weeks

  • C-peptide

    12 weeks

  • Fasting serum insulin

    12 weeks

  • Body mess index

    12 weeks

Study Arms (1)

newly diagnosed T2DM participants

newly diagnosed T2DM participants without anti-diabetic drugs intake

Drug: Exenatide treatment

Interventions

Exenatide treatmentDRUG

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.

Also known as: exenatide
newly diagnosed T2DM participants

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Chinese population

You may qualify if:

  • Newly diagnosed T2DM patients

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Chao-yang hospital

Beijing, 100020, China

Location

Related Publications (1)

  • 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.

    PMID: 32539783DERIVED

MeSH Terms

Interventions

Exenatide

Intervention Hierarchy (Ancestors)

PeptidesAmino Acids, Peptides, and ProteinsVenomsComplex MixturesToxins, BiologicalBiological Factors

Study Officials

  • Boyu Li, PHD

    Beijing Chao Yang Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

March 4, 2020

First Posted

March 11, 2020

Study Start

January 5, 2020

Primary Completion

January 28, 2020

Study Completion

January 31, 2020

Last Updated

June 11, 2020

Record last verified: 2020-06

Locations

CN(1)