Type 2 Diabetes Clinical Trial
Official title:
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.
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/
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/
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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