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

Condition(s) targeted: Type 2 Diabetes

Intervention: UMULINE NPH (Drug); pioglitazone (Drug)

Phase: N/A

Status: Terminated

Sponsored by: Assistance Publique - Hôpitaux de Paris

Official(s) and/or principal investigator(s):
Agnès Hartemann-Heurtier, MDPHD, Principal Investigator, Affiliation: Assistance Publique des Hôpitaux de Paris Hôpital Pitié Salpêtrière France

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/

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.

Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Abdominal adipose tissue (on scan) variation at 6 month

Secondary outcome:

Cellularity of subcutaneous adipose variation tissue at 6 month

HbA1c, lipid level, adiponectin, CRP variation at 6 month

inflammation gene expression in sub-cutaneous fat

Detailed description: 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/

Minimum age: 35 Years. Maximum age: 75 Years. Gender(s): Both.

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

Sce de Diabétologie, hôpital de la Pitié-salpêtrière, 83bld de l'hôpital, Paris 75013, France

Starting date: May 2005
Ending date: May 2007
Last updated: November 6, 2007