Effects of GLP-1 Receptor Agonist on Fat Redistribution and Inflammatory Status

Obesity Clinical Trial

Official title:

Effects of GLP-1 Receptor Agonist on Fat Redistribution and Inflammatory Status in Female Patients With Type 2 Diabetes and Obesity

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02118376
• Other study ID #: GLP-1
• Status: Not yet recruiting
• Phase: N/A
• First received: December 20, 2013
• Last updated: April 16, 2014
• Start date: August 2014
• Est. completion date: December 2014

Study information

• Verified date: December 2013
• Source: Shanghai 10th People's Hospital
• Contact: Yu Jie
• Phone: 13916674766
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

GLP-1 receptor agonists promote fat redistribution in obese women with type 2 diabetes, reduce liver fat content, improve the inflammation state

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity

Intervention

Drug:
• Exenatide
5ug bid,Subcutaneous injection

Locations

Country	Name	City	State
China	Shanghai Tenth People' Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai 10th People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	lab testing	liver function	3 months	Yes
Primary	Dual energy X-ray absorptiometry	fat distribution	3 month	No
Secondary	lab testing	inflammation	3 month	No