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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

This study is currently recruiting participants.
Verified May 2012 by Cardiovascular Institute & Fuwai Hospital
Sponsor:
Information provided by (Responsible Party):
Guangwei Li, Cardiovascular Institute and Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union M
ClinicalTrials.gov Identifier:
NCT01610154
First received: May 30, 2012
Last updated: May 31, 2012
Last verified: May 2012
History of Changes
  Purpose
  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.

Condition
Insulin Secretion
Insulin Resistance

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Cardiovascular Institute & Fuwai Hospital:

Primary Outcome Measures:
  • pancreatic α cells function [ Time Frame: 12 weeks after treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • insulin secretion and insulin resistance [ Time Frame: 12 weeks after treatment ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   Samples Without DNA

serum


Estimated Enrollment: 140
Study Start Date: May 2012
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Sitagliptin treatment

  Eligibility

Ages Eligible for Study:   25 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

primary care clinic

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01610154

Contacts
Contact: Yanyan Chen +86 1088396575 doc.yan@medmail.com.cn

Locations
China
Fuwai Hospital Recruiting
Beijing, China
Contact: Guangwei Li     +86 1088396587     guangwei.li@hotmail.com    
Sponsors and Collaborators
Guangwei Li
  More Information

No publications provided

Responsible Party: Guangwei Li, director of endocrinology and cardiovascular disease center of Fuwai hospital, Cardiovascular Institute and Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union M
ClinicalTrials.gov Identifier: NCT01610154     History of Changes
Other Study ID Numbers: CIFuwaiHospital-MISP39889
Study First Received: May 30, 2012
Last Updated: May 31, 2012
Health Authority: China: Ministry of Health

Keywords provided by Cardiovascular Institute & Fuwai Hospital:
glucagon
dipeptidyl peptidase-4 inhibitor

Additional relevant MeSH terms:
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Sitagliptin
Dipeptidyl-Peptidase IV Inhibitors
 Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 18, 2013