- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02118376
Effects of GLP-1 Receptor Agonist on Fat Redistribution and Inflammatory Status
April 16, 2014 updated by: Zhang Manna, Shanghai 10th People's Hospital
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
Study Overview
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 Type
Interventional
Enrollment (Anticipated)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Yu Jie
- Phone Number: 13916674766
Study Locations
-
-
Shanghai
-
Shanghai, Shanghai, China, 200072
- Shanghai Tenth People' Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Clinical diagnosis of overweight and type 2 diabetes mellitus
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: exenatide
exenatide, 5ug, bid, 3months
|
5ug bid,Subcutaneous injection
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dual energy X-ray absorptiometry
Time Frame: 3 month
|
fat distribution
|
3 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
lab testing
Time Frame: 3 month
|
inflammation
|
3 month
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
lab testing
Time Frame: 3 months
|
liver function
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Qu Shen, Shang Tenth People's Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2014
Primary Completion (Anticipated)
December 1, 2014
Study Completion (Anticipated)
December 1, 2014
Study Registration Dates
First Submitted
December 20, 2013
First Submitted That Met QC Criteria
April 16, 2014
First Posted (Estimate)
April 21, 2014
Study Record Updates
Last Update Posted (Estimate)
April 21, 2014
Last Update Submitted That Met QC Criteria
April 16, 2014
Last Verified
December 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GLP-1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Obesity
-
Central Hospital, Nancy, FranceNot yet recruiting
-
University of MinnesotaNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Active, not recruitingAdolescent ObesityUnited States
-
Helsinki University Central HospitalKarolinska Institutet; Folkhälsan Researech CenterEnrolling by invitation
-
Istanbul Medipol University HospitalMedipol UniversityCompletedObesity, Morbid | Obesity, Adolescent | Obesity, Abdominal | Weight, Body | Obesity, VisceralTurkey
-
Queen Fabiola Children's University HospitalNot yet recruitingMorbid Obesity | Adolescent Obesity | Bariatric SurgeryBelgium
-
Azienda Ospedaliero-Universitaria Consorziale Policlinico...Institute of Biomembranes, Bioenergetics and Molecular Biotechnologies; Istituti... and other collaboratorsCompletedMorbid Obesity | Metabolically Healthy ObesityItaly
-
Washington University School of MedicinePatient-Centered Outcomes Research Institute; Pennington Biomedical Research... and other collaboratorsActive, not recruitingOvernutrition | Nutrition Disorders | Overweight | Body Weight | Pediatric Obesity | Body Weight Changes | Childhood Obesity | Weight Gain | Adolescent Obesity | Obesity, Childhood | Overweight and Obesity | Overweight or Obesity | Overweight AdolescentsUnited States
-
Fundació Sant Joan de DéuNot yet recruitingObesity, Childhood | Obesity, AdolescentSpain
-
Consorcio Centro de Investigación Biomédica en...Maimónides Biomedical Research Institute of Córdoba; Instituto de Salud Carlos... and other collaboratorsActive, not recruiting
-
University of HoustonBaylor College of MedicineCompleted
Clinical Trials on Exenatide
-
AstraZenecaEli Lilly and CompanyCompletedType 2 Diabetes MellitusUnited States
-
AstraZenecaCompletedType 2 Diabetes MellitusCanada, United States
-
AstraZenecaEli Lilly and CompanyCompletedType 2 Diabetes MellitusKorea, Republic of, China, Japan, Taiwan, India
-
AstraZenecaCompletedDiabetes Mellitus, Type 2United States
-
Beijing Chao Yang HospitalCompleted
-
AstraZenecaEli Lilly and CompanyCompletedType 2 Diabetes MellitusKorea, Republic of, Mexico, Germany, Greece, Argentina, India, Australia
-
AstraZenecaCelerionCompleted
-
AstraZenecaEli Lilly and CompanyCompletedType 2 Diabetes MellitusUnited States
-
AstraZenecaEli Lilly and CompanyCompletedType 2 DiabetesUnited States
-
University at BuffaloAmylin Pharmaceuticals, LLC.Completed