ObesityNCT02118376
Effects of GLP-1 Receptor Agonist on Fat Redistribution and Inflammatory Status
A study testing Exenatide in people with Obesity, run by Shanghai 10th People's Hospital at 1 site in China.
Trial summary
GLP-1 receptor agonists promote fat redistribution in obese women with type 2 diabetes, reduce liver fat content, improve the inflammation state Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Obesity
- What is being tested?
- Exenatide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- Aug 2014to Dec 2014
- Phase
- Interventional
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of overweight and type 2 diabetes mellitus
Who cannot join
- Poor body condition (severe liver and kidney dysfunction)
- Unknown causes of pancreatitis, chronic pancreatitis, pancreatic resection, stomach operation, malignant tumor, previous use of systemic corticosteroids (local or inhalation of exceptions) heart function or niacin, incomplete
- serious endocrine disease
- genetic disease
Trial locations and contacts
1 site in 1 country.
Yu Jie contact
China1 site
Shanghai Tenth People' Hospital
Shanghai, Shanghai Municipality, 200072
About this study
Official title: Effects of GLP-1 Receptor Agonist on Fat Redistribution and Inflammatory Status in Female Patients With Type 2 Diabetes and Obesity
GLP-1 receptor agonists promote fat redistribution in obese women with type 2 diabetes, reduce liver fat content, improve the inflammation state
Read the detailed description
As a treatment for type 2 diabetesGlucagon like peptide -1 (Glucan-like peptide-1, GLP-1) receptor agonists plays the role of promoting insulin secretion, inhibiting glucagon secretion，and also has the central and peripheral effects,it can inhibit appetite,reduce weight.GLP-1 receptor agonists promote fat redistribution in obese women with type 2 diabetes, reduce liver fat content, improve the inflammation state
- Conditions
- Obesity
- Being tested
- Exenatide
- Keywords
- obesity; fat distribution; inflammation
- Medical subject headings
- Obesity, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExenatideDrug
Also called Byetta
5ug bid,Subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| exenatide | Experimental | exenatide, 5ug, bid, 3months Receives: Drug: Exenatide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dual energy X-ray absorptiometry
fat distribution
Measured: 3 month
Secondary outcomes (1)
lab testing
inflammation
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2014 (estimated)
- Study startAug 2014
- Primary completionDec 2014 (estimated)
- Study completionDec 2014 (estimated)
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 ObesityStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai 10th People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhang Manna, Shanghai 10th People's Hospital
- Investigators
- Qu Shen, Study director, Shang Tenth People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02118376
- Sponsor's protocol ID
- GLP-1
- Status last verified
- Dec 2013
- First submitted
- 20 Dec 2013
- Last updated
- 21 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Wang X, Chen J, Li L, Zhu CL, Gao J, Rampersad S, Bu L, Qu S. New association of bone morphogenetic protein 4 concentrations with fat distribution in obesity and Exenatide intervention on it. Lipids Health Dis. 2017 Apr 4;16(1):70. doi: 10.1186/s12944-017-0462-1.
PubMed 28376799
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of GLP-1 Receptor Agonist on Fat Redistribution and Inflammatory Status in Female Patients With Type 2 Diabetes and Obesity
- ClinicalTrials.gov ID
- NCT02118376
- Acronym / sponsor ID
- GLP-1
- Conditions
- Obesity
- Keywords
- obesity; fat distribution; inflammation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Shanghai 10th People's HospitalUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 21 Apr 2014 (estimated)
- 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.
GLP-1 receptor agonists promote fat redistribution in obese women with type 2 diabetes, reduce liver fat content, improve the inflammation state
Detailed description
As a treatment for type 2 diabetesGlucagon like peptide -1 (Glucan-like peptide-1, GLP-1) receptor agonists plays the role of promoting insulin secretion, inhibiting glucagon secretion，and also has the central and peripheral effects,it can inhibit appetite,reduce weight.GLP-1 receptor agonists promote fat redistribution in obese women with type 2 diabetes, reduce liver fat content, improve the inflammation state
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| exenatide | Experimental | Drug: Exenatideexenatide, 5ug, bid, 3months |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical diagnosis of overweight and type 2 diabetes mellitus
Key exclusion criteria (4 listed)
- Poor body condition (severe liver and kidney dysfunction)
- Unknown causes of pancreatitis, chronic pancreatitis, pancreatic resection, stomach operation, malignant tumor, previous use of systemic corticosteroids (local or inhalation of exceptions) heart function or niacin, incomplete
- serious endocrine disease
- genetic disease
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 |
|---|---|---|
| ExenatideAlso: Byetta5ug bid,Subcutaneous injection | Drug | exenatide |
Primary outcome
Dual energy X-ray absorptiometry
Time frame: 3 month
fat distribution
1 secondary outcome
lab testing
Time frame: 3 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2014.
- Derived from this study: PubMed 28376799Wang X, Chen J, Li L, Zhu CL, Gao J, Rampersad S, Bu L, Qu S. New association of bone morphogenetic protein 4 concentrations with fat distribution in obesity and Exenatide intervention on it. Lipids Health Dis. 2017 Apr 4;16(1):70. doi: 10.1186/s12944-017-0462-1.
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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.
Yu Jie contact
Qu Shen study director
Shang Tenth People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exenatide in people with Obesity, run by Shanghai 10th People's 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 4 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: status not confirmed, as of the sponsor's last update on 21 Apr 2014. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yu Jie (13916674766), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dual energy X-ray absorptiometry (time frame: 3 month). 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 NCT02118376, 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 21 Apr 2014.