Contribution of Pancreatic αcells Function to Blood Glucose Regulation in Chinese Type 2 Diabetics― the Effect of Sitagliptin on Glucagon Secretion, Insulin Secretion and Insulin Resistance in Chinese Type 2 Diabetics

Insulin Resistance Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01610154
• Other study ID #: CIFuwaiHospital-MISP39889
• Status: Recruiting
• Phase: N/A
• First received: May 30, 2012
• Last updated: May 31, 2012
• Start date: May 2012
• Est. completion date: March 2013

Study information

• Verified date: May 2012
• Source: Chinese Academy of Medical Sciences, Fuwai Hospital
• Contact: Yanyan Chen
• Phone: +86 1088396575
• Email: doc.yan[@]medmail.com.cn
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Observational

Clinical Trial Summary

1. The purpose of this study is to determine whether Sitagliptin therapy suppress glucagon release and improve glucose control in Chinese type 2 diabetic.

2. There are different effects of Sitagliptin therapy on blood glucose regulation, pancreatic alpha & beta cell function are different in lean (BMI<25) and overweight (BMI>25) Chinese type 2 diabetics.

3. The purpose of this study is to determine whether glucagon release may contribute over 30% to the hyperglycemia in Chinese type 2 diabetics.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: March 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 60 Years

Eligibility

Inclusion Criteria:

1. Age: 25~60 years

2. Duration of disease < 3 years,no drug treatment for diabetes

3. Newly diagnosed type 2 diabetic patients (fasting plasma glucose > 7.0mmol/L or/and 2h postprandial blood glucose>11.1mmol/L WHO 1999)

4. Fasting plasma glucose < 10 mmol/L

Exclusion Criteria:

1. Type 1 diabetes

2. DKA, infection and other stress status

3. Autoimmune disease

4. Hepatic and renal diseases

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Insulin Resistance
• Insulin Secretion

Locations

Country	Name	City	State
China	Fuwai Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Guangwei Li

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pancreatic a cells function		12 weeks after treatment	Yes
Secondary	insulin secretion and insulin resistance		12 weeks after treatment	Yes