Trial record 4 of 968 for:    Open Studies | "Insulin"

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by Cardiovascular Institute & Fuwai Hospital.
Recruitment status was  Recruiting
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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 28, 2014