Clinical trial NCT01889914: TReatment by Insulin Continuous Infusion in Type 2 DIAbetes
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Diabetes
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2013-07-01
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* age \> 18 years old
* type 2 diabete patient with insuline basal/bolus treatment for at least 6 months
* Doses of insuline \> 0,7 U/Kg/j
* HbA1c ≥ 7,5%
* without ADO for at least 4 weeks (sulfamides, Incrétines, glinides, acarbose) except the metformine
* BMI ≥ 28,5 kg/m²
* clinical diagnostique of diabetes for at least 10 ans
* Patient must be able to Realize an automonitoring and to manage the functioning of an insulin pump.

Exclusion Criteria:

* glitazone treatment less than 3 month before inclusion
* Patient with an untreated by the laser proliferative ischemic retinopathy
* BMI \< 28,5 kg/m²
* Pacemaker (CI IRM)
* Presence of implantable material (CI IRM)
* Pregnancy, breast-feeding
* Practices of violent sports
* Professional extreme environment of cold or heat
* Serious psychiatric diseases physical and/or psychiatric Incapacitated medically significant
* Poor sanitation

Primary outcomes:
measure: changes from baseline in insulinoresistance measured by biological tests of hyperinsulinemic euglycemic clamp in the two groups of treatment 6 months after the start of the treatment.
timeFrame: baseline and six months after the begining of the study
Secondary outcomes:
measure: change from baseline in the hyperglycemia time spent during basal and prandial period with continuous glucose monitoring tool at 6 months
timeFrame: baseline and six months after the beginning of the study
measure: change from baseline in HbA1c in the two groups of treatment at three, six, nine and twelve months
timeFrame: baseline and three, six, nine, twelve months
measure: change from baseline in quality of life measured with questionnaires at 6 months
timeFrame: baseline and 6 months
measure: change from baseline in weight at three, six, nine and twelve months in the two groups.
timeFrame: baseline and three, six, nine and twelve months
Other outcomes:
Locations:
city: Dijon
country: France
facility: CHU
Study officials:
affiliation: CHU de BOCAGE, DIJON, FRANCE
name: Sabine RUDONI, MD
role: PRINCIPAL_INVESTIGATOR
References: