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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 has been completed.
Sponsor:
Information provided by (Responsible Party):
Guangwei Li, Chinese Academy of Medical Sciences, Fuwai Hospital
ClinicalTrials.gov Identifier:
NCT01610154
First received: May 30, 2012
Last updated: April 5, 2017
Last verified: April 2017
  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 Intervention Phase
Insulin Secretion Insulin Resistance Drug: Sitagliptin Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Guangwei Li, Chinese Academy of Medical Sciences, Fuwai Hospital:

Primary Outcome Measures:
  • Change From Baseline in Hemoglobin A1c (HbA1c) [ Time Frame: Baseline to 12 weeks ]

Secondary Outcome Measures:
  • Change From Baseline in Fasting Plasma Glucose (FPG) [ Time Frame: Baseline to 12 weeks ]
  • Change From Baseline in Postprandial Plasma Glucose (PPG) [ Time Frame: Baseline to 12 weeks ]
  • Change From Baseline in Insulin Sensitivity [ Time Frame: Baseline to 12 weeks ]
    The insulin sensitivity was detected by evaluating the glucose infusion rate (GIR) with euglycemic hyperinsulinemic clamp test.

  • Change From Baseline in Insulin Sensitivity in Patients With Different BMI [ Time Frame: Baseline to 12 weeks ]
    The insulin sensitivity was detected by evaluating the glucose infusion rate (GIR) with euglycemic hyperinsulinemic clamp test.

  • Change From Baseline in Pancreatic β Cell Function [ Time Frame: Baseline to 12 weeks ]
    The early phase insulin response (△I30/△G30) was adopted to determine β cell function.

  • Change From Baseline in Pancreatic β Cell Function in Patients With Different BMI [ Time Frame: Baseline to 12 weeks ]
    The early phase insulin response (△I30/△G30) was adopted to determine β cell function.

  • Change From Baseline in Pancreatic α Cell Function [ Time Frame: Baseline to 12 weeks ]
    The glucagon-AUC was adopted to show pancreatic α cell function.

  • Change From Baseline in Pancreatic α Cell Function in Patients With Different BMI [ Time Frame: Baseline to 12 weeks ]
    The glucagon-AUC was adopted to show pancreatic α cell function.


Enrollment: 85
Study Start Date: October 2012
Study Completion Date: June 2015
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sitagliptin treatment Drug: Sitagliptin
Sitagliptin 100 mg QD for 12 weeks

  Eligibility

Ages Eligible for Study:   25 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Locations
China
Fuwai Hospital
Beijing, China
Sponsors and Collaborators
Guangwei Li
  More Information

Responsible Party: Guangwei Li, director of endocrinology and cardiovascular disease center of Fuwai hospital, Chinese Academy of Medical Sciences, Fuwai Hospital
ClinicalTrials.gov Identifier: NCT01610154     History of Changes
Other Study ID Numbers: CIFuwaiHospital-MISP39889
Study First Received: May 30, 2012
Results First Received: November 27, 2016
Last Updated: April 5, 2017

Keywords provided by Guangwei Li, Chinese Academy of Medical Sciences, Fuwai Hospital:
glucagon
dipeptidyl peptidase-4 inhibitor

Additional relevant MeSH terms:
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Sitagliptin Phosphate
Glucagon
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents

ClinicalTrials.gov processed this record on August 16, 2017