TReatment by Insulin Continuous Infusion in Type 2 DIAbetes — TRICIDIA2  

Diabetes Clinical Trial

Official title: Treatment by Subcutaneous Continuous Infusion of Insulin by Portable Pump Versus Discontinuous Infusion of Insulin by Multi-injections in the Type 2 Diabetes: Study of the Insulinosensibility in the 2 Types of Treatments

Status Recruiting

Clinical Trial Summary

The aim of the TRICIDIA2 study is to compare two modalities of administration of insulin.

In our future study, the investigators wish to study if the treatment by continuous infusion of insulin improves the insulinosensitivity of type 2 diabetic patients; the investigators indeed expect that the insulin delivered in a continuous way decreases the insulino-resistance of these patients compared with the intermittent delivering of insulin.

Clinical Trial Description

We wish to use before and after treatment the classic tools of measure of insulinosensitivity / the euglycemic hyperinsulinemic clamp associated with a measure of the insulinosecretion thanks to a test of load in glucose IV. The coupling in the same procedure of these 2 tests is the Botnia clamp. We also wish to use the continuous measure of subcutaneous glucose during several days to estimate the reduction in the average glycemia on the fast and prandial periods as well as the decrease of the time spent in hyperglycemia during the day. This tool demonstrated its interest in type 2 diabetic population in several studies. Finally the current / spectro-IRM methods of imaging are now validated to quantify and measure exactly the importance of the steatosis, including in type 2 patients, because we know that it is probably the result of the insulino-resistance; We would also like to demonstrate that some genetic polymorphisms of proteins (polymorphisms G / T493 of the MTP, 1927 C/T of the receiver R1 of the adiponectin and 265 C/T of the gene of Apolipoprotéines A) are factors which can modulate the steatosis development in case of type 2 diabetes.

In other secondary criteria we wait for an improvement of HbA1c, quality of life of type 2 obese people with regard to the treatment by intensified Multi-injections. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Diabetes

• NCT number: NCT01889914
• Study type: Interventional
• Source: Centre Hospitalier Universitaire Dijon
• Status: Recruiting
• Phase: Phase 4
• Start date: January 2012
• Completion date: September 2015