Abdominal Adipose Tissue Distribution in Type 2 Diabetic Patients Treated During 6 Months With Pioglitazone or Insulin

Study Overview
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Brief Summary
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In type 2 diabetic patients with poor glycemic control despite maximum classic oral treatment, bed time insulin therapy may lead to a parallel increase in abdominal visceral and subcutaneous fat, whereas pioglitazone treatment should lead to a stability (or even a decrease ) in visceral and an increase in subcutaneous abdominal fat. As visceral fat mass is correlated with insulin-resistance and cardio-vascular risk, the evolution of visceral abdominal fat in type 2 diabetic patients is of great importance. Main objective: To compare visceral and subcutaneous abdominal fat compartment after a six-month bed time insulin or pioglitazone treatment in type 2 diabetic patients with poor glycemic control despite a maximal oral treatment with metformin and sulfonylureas. The study hypothesis is that quantity of visceral and subcutaneous abdominal adipose tissue should differently evolute comparing a 6 month treatment with pioglitazone® (30 or 45mg/j) or NPH  bed-time  insulin (0.2u/kg/

Detailed Description
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In type 2 diabetic patients with poor glycemic control despite maximum classic oral treatment, bed time insulin therapy may lead to a parallel increase in abdominal visceral and subcutaneous fat, whereas pioglitazone treatment should lead to a stability (or even a decrease ) in visceral and an increase in subcutaneous abdominal fat. As visceral fat mass is correlated with insulin-resistance and cardio-vascular risk, the evolution of visceral abdominal fat in type 2 diabetic patients is of great importance. The study hypothesis is that quantity of visceral and subcutaneous abdominal adipose tissue should differently evolute comparing a 6 month treatment with pioglitazone® (30 or 45mg/j) or NPH  bed-time  insulin (0.2u/kg/

Official Title
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Evolution of Abdominal Adipose Tissue Distribution in Type 2 Diabetic Patients Treated During 6 Months With Pioglitazone or Insulin, in Association With Metformin or Sulfonylurea.

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Drug: UMULINE NPH
* Drug: pioglitazone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 2 diabetes BMI= 26kg/m2 Maximal treatment with metformin and sulfonylurea HbA1c between 7.5 and 9.5% Exclusion Criteria: Anterior treatment with glitazones Anterior treatment with insulin Known heart failure Hepatopathy Renal filtration less than 60ml/min, Hb<10g/dl Corticoids treatment

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>UMULINE NPH at bed time | Drug: UMULINE NPH<br>* UMULINE NPH at bed time with a increasing dose up to get a fasting glycemia under 1.1 g/l<br>|
| Experimental: 2<br>pioglitazone 30 mg | Drug: pioglitazone<br>* 30mg daily. After 2 months, if HbA1c has not decreased at least of 1%, the dosage should be increased to 45 mg daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Abdominal adipose tissue (on scan) variation at 6 month |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cellularity of subcutaneous adipose variation tissue at 6 month |  | 6 months | 
| HbA1c, lipid level, adiponectin, CRP variation at 6 month |  | 6 months | 
| inflammation gene expression in sub-cutaneous fat |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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type 2 diabetes