A Crossover Study to Assess the 2 Glucose Tolerance Tests on Incretin, Beta-cell function and Insulin Sensitivity in Japanese Healthy and Type 2 Diabetes Subjects
- Conditions
- T2DM
- Registration Number
- JPRN-UMIN000014575
- Lead Sponsor
- Kansai Electric Power Hospital
- Brief Summary
Hypersecretion of glucagon and reduced insulin secretion both contribute to hyperglycemia in type 2 diabetes (T2DM). However, the relative contributions of impaired glucagon and insulin secretions in glucose excursions at the various stages of T2DM development remain to be determined. In OGTT, T2DM showed a rise in glucagon at 0-30min, unlike NGT and IGT, along with reduced insulin. In MTT, all three groups showed a rise in glucagon at 0-30min, with that in T2DM being highest, while T2DM showed a significant reduction in insulin. Linear regression analyses revealed that glucose area under the curve (AUC)0-120 min was associated with glucagon-AUC0-30 min and insulin-AUC0-30 min in both OGTT and MTT. Total and biologically intact GIP and GLP-1 levels were similar among the three groups. Disordered early phase insulin and glucagon secretions but not incretin secretion are involved in hyperglycemia after ingestion of nutrients in T2DM of even a short duration.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Male
- Target Recruitment
- 32
Not provided
1) Patients with diabetes requiring insulin therapy (insulin intensive therapy, T1DM, etc) 2) Patients treated with any anti-diabetic drugs 3) Patients with heart disease 4) Patients with renal dysfunction 5) Patients with severe hepatic dysfunction 6) Patients with history of pancreatitis 7) Patients with a history of surgery of gastrointestinal tract 8) Patients with malignant tumor(s) 9) Patients with severe infection, in the perioperative period or with serious injury 10) Excessive alcohol intake or drug abuse 11) Patients found ineligible as a study patient according to the discretion of the investigator or sub-investigator 12)Pregnant or possibly pregnant women
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess effects of two glucose tolerance tests (75g OGTT and mixed meal) on following parameters in Japanese T2DM and healthy volunteers; 1) Changes in plasma glucose levels 2) Changes in serum insulin and C-peptide levels 3) Changes in plasma glucagon levels 4) Changes in plasma GIP (total, intact) levels 5) Changes in plasma GLP-1 (total, intact) levels
- Secondary Outcome Measures
Name Time Method