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: 0
• Participant gender: All

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/

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborator: Laboratoires Takeda
• Treatments: Pioglitazone

Criteria

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