Abdominal Adipose Tissue Distribution in Type 2 Diabetic Patients Treated During 6 Months With Pioglitazone or Insulin
Status:
Terminated
Trial end date:
2007-05-01
Target enrollment:
Participant gender:
Summary
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/