Clinical trial NCT00159211: Abdominal Adipose Tissue Distribution in Type 2 Diabetic Patients Treated During 6 Months With Pioglitazone or Insulin
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Type 2 Diabetes
Keywords: type 2 diabetes
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Laboratoires Takeda
First posted: 2005-09-12
Enrollment: 28
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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/

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/

Eligibility 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

Primary outcomes:
measure: Abdominal adipose tissue (on scan) variation at 6 month
timeFrame: 6 months
Secondary outcomes:
measure: Cellularity of subcutaneous adipose variation tissue at 6 month
timeFrame: 6 months
measure: HbA1c, lipid level, adiponectin, CRP variation at 6 month
timeFrame: 6 months
measure: inflammation gene expression in sub-cutaneous fat
timeFrame: 6 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Sce de Diabétologie, hôpital de la Pitié-salpêtrière, 83bld de l'hôpital
Study officials:
affiliation: Assistance Publique des Hôpitaux de Paris Hôpital Pitié Salpêtrière France
name: Agnès Hartemann-Heurtier, MDPHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hartemann-Heurtier A, Halbron M, Golmard JL, Jacqueminet S, Bastard JP, Rouault C, Ayed A, Pieroni L, Clement K, Grimaldi A. Effects of bed-time insulin versus pioglitazone on abdominal fat accumulation, inflammation and gene expression in adipose tissue in patients with type 2 diabetes. Diabetes Res Clin Pract. 2009 Oct;86(1):37-43. doi: 10.1016/j.diabres.2009.06.028. Epub 2009 Aug 15.