"Effect of Dipeptidyl Peptidase IV After Diets in näive Type 2 Diabetic Patients"

Diabetes Type 2 Clinical Trial

Official title: "Effect of Dipeptidyl Peptidase IV Inhibitors on Glycemia, Insulin, Glucagon, C Peptide, Glp 1 and Lipids After Isocaloric Meals With Different Nutritional Composition in Patients With Type 2 Diabetes näive of Treatment"

Status Completed

Clinical Trial Summary

The purpose of this study is to demonstrate the secretion of glucose, insulin, glucagon, C-peptide and lipid profile after isocaloric diets with different nutritional compounds (fat, protein and carbohydrate food) in drug näive tipo 2 patients.

Clinical Trial Description

It is well known that there is a progressive deterioration in beta-cell function over time in type 2 diabetes (DM2), as indicated by the UKPDS (United Kingdom Prospective Diabetes Study), regardless of therapy allocation, albeit conventional (mainly diet), insulin, chlorpropamide, glibenclamide or metformin treatment. Moreover, the pancreatic islet function was found to be about 50% of normal at the time of diagnosis, independent of the degree of insulin resistance, with the reduction in function probably commencing 10-12 years prior to diagnosis and aggravated by increasing fasting plasma glucose levels.

Optimal metabolic control, especially early intensive glycemic control, plays a role in the prevention of progressive beta cell dysfunction and possibly destruction of the betacells with worsening of diabetes. Many reports have shown that induction of normoglycemia in DM2 results in both improved beta cell function and insulin resistance.The major therapeutic drawback using native GLP-1 is its very short half-life of less than 2 minutes, following exogenous administration, as previously indicated due in part to the protease DDP-IV a result, preventing the degradation of native GLP-1 by inhibiting the active of the DDP-IV enzyme has emerged as a therapeutic strategy for enhancing endogenous GLP-1 action in vivo.Considering that, sitagliptin is the first FDA and ANVISA authorized dipeptidyl peptidase-IV (DPP-IV) inhibitor for diabetes treatment and considering the lack of data about DPP-IV inhibitor effect over glucose, glucagon, insulin, C -peptide and fats after isocaloric diets with different nutritional composition in drug näive patients with type 2 diabetes, we designed this study. ;

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Diabetes Type 2

• NCT number: NCT00881543
• Study type: Interventional
• Source: University of Sao Paulo General Hospital
• Status: Completed
• Phase: N/A
• Start date: June 2009
• Completion date: October 2011