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Abdominal Adipose Tissue Distribution in Type 2 Diabetic Patients Treated During 6 Months With Pioglitazone or Insulin
This study has been terminated.
( inclusion was finished )
Study NCT00159211   Information provided by Assistance Publique - Hôpitaux de Paris
First Received: September 7, 2005   Last Updated: November 6, 2007   History of Changes

September 7, 2005
November 6, 2007
May 2005
 
Abdominal adipose tissue (on scan) variation at 6 month [ Time Frame: 6 months ]
Abdominal adipose tissue (on scan) variation at 6 month
Complete list of historical versions of study NCT00159211 on ClinicalTrials.gov Archive Site
  • Cellularity of subcutaneous adipose variation tissue at 6 month [ Time Frame: 6 months ]
  • HbA1c, lipid level, adiponectin, CRP variation at 6 month [ Time Frame: 6 months ]
  • inflammation gene expression in sub-cutaneous fat [ Time Frame: 6 months ]
  • Cellularity of subcutaneous adipose variation tissue at 6 month
  • Hepatic adipose tissue variation at 6 month
  • HbA1c, lipid level, adiponectin, CRP variation at 6 month
 
Abdominal Adipose Tissue Distribution in Type 2 Diabetic Patients Treated During 6 Months With Pioglitazone or Insulin
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/

 
Interventional
Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Type 2 Diabetes
  • Drug: UMULINE NPH
  • Drug: pioglitazone
  • Active Comparator: UMULINE NPH at bed time
  • Experimental: pioglitazone 30 mg
Hartemann-Heurtier A, Halbron M, Golmard JL, Jacqueminet S, Bastard JP, Rouault C, Ayed A, Pieroni L, Clément 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. Epub 2009 Aug 15.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Terminated
28
May 2007
 

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
Both
35 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00159211
 
P031006
Assistance Publique - Hôpitaux de Paris
Laboratoires Takeda
Principal Investigator: Agnès Hartemann-Heurtier, MDPHD Assistance Publique des Hôpitaux de Paris Hôpital Pitié Salpêtrière France
Assistance Publique - Hôpitaux de Paris
April 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP