Type 2 Diabetes Mellitus in ObeseNCT04303819
The Effect of Exenatide on Fasting Bile Acids
An observational study of Type 2 Diabetes Mellitus in Obese, run by Beijing Chao Yang Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type 2 Diabetes Mellitus in Obese
- What is being tested?
- Exenatide treatment
- Type of treatment
- Injection or infusion
- How many people
- 38 participants
- Where
- 1 siteChina
- Study dates
- 5 Jan 2020to 31 Jan 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Chinese population
Who may be able to join
- Newly diagnosed T2DM patients
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Exenatide on Fasting Bile Acids in Newly Diagnosed Type 2 Diabetes Mellitus Patients, a Pilot Study
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.
Read the 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.
- Conditions
- Type 2 Diabetes Mellitus in Obese
- Being tested
- Exenatide treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exenatide treatmentDrug
Also called exenatide
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.
| Study group | Role | What they receive |
|---|---|---|
| newly diagnosed T2DM participants | newly diagnosed T2DM participants without anti-diabetic drugs intake Receives: Drug: Exenatide treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma total bile acids in fasting state
reported in μmol/L
Measured: 12 weeks
Secondary outcomes (5)
fasting plasma glucose
reported in mmol/L
Measured: 12 weeks
Glycated hemoglobin A1c
reported in %
Measured: 12 weeks
C-peptide
reported in mU/L
Measured: 12 weeks
Fasting serum insulin
reported in mU/L
Measured: 12 weeks
Body mess index
reported in kg/m^2
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2020
- Study start5 Jan 2020
- Primary completion28 Jan 2020
- Study completion31 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes Mellitus in ObeseStudies of the same condition, open and under way.
- More trials run by Beijing Chao Yang HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Chao Yang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lihong Liu, Beijing Chao Yang Hospital
- Investigators
- Boyu Li, PHD, Principal investigator, Beijing Chao Yang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04303819
- Sponsor's protocol ID
- 20131212
- Status last verified
- Jun 2020
- First submitted
- 4 Mar 2020
- Last updated
- 11 Jun 2020
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
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.
PubMed 32539783
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Exenatide on Fasting Bile Acids in Newly Diagnosed Type 2 Diabetes Mellitus Patients, a Pilot Study
- ClinicalTrials.gov ID
- NCT04303819
- Acronym / sponsor ID
- 20131212
- Conditions
- Type 2 Diabetes Mellitus in Obese
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Beijing Chao Yang HospitalUniversity, hospital or other
- Study start
- 5 Jan 2020 (actual)
- Primary completion
- 28 Jan 2020 (actual)
- Study completion
- 31 Jan 2020 (actual)
- First posted
- 11 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| newly diagnosed T2DM participants | – | Drug: Exenatide treatmentnewly diagnosed T2DM participants without anti-diabetic drugs intake |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Chinese population
Key inclusion criteria (1 listed)
- Newly diagnosed T2DM patients
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exenatide treatmentAlso: exenatide12 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. | Drug | newly diagnosed T2DM participants |
Primary outcome
Plasma total bile acids in fasting state
Time frame: 12 weeks
reported in μmol/L
5 secondary outcomes
fasting plasma glucose
Time frame: 12 weeks
Glycated hemoglobin A1c
Time frame: 12 weeks
C-peptide
Time frame: 12 weeks
Fasting serum insulin
Time frame: 12 weeks
Body mess index
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2020.
- Derived from this study: PubMed 32539783Li 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Boyu Li, PHD principal investigator
Beijing Chao Yang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes Mellitus in Obese, run by Beijing Chao Yang Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma total bile acids in fasting state (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04303819, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2020.