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)
Sponsor:
Collaborator:
Laboratoires Takeda
Information provided by:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00159211
First received: September 7, 2005
Last updated: November 6, 2007
Last verified: April 2007

September 7, 2005
November 6, 2007
May 2005
Not Provided
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
Not Provided
Not Provided
 
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
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Type 2 Diabetes
  • Drug: UMULINE NPH
    UMULINE NPH at bed time with a increasing dose up to get a fasting glycemia under 1.1 g/l
  • Drug: pioglitazone
    30mg daily. After 2 months, if HbA1c has not decreased at least of 1%, the dosage should be increased to 45 mg daily
  • Active Comparator: 1
    UMULINE NPH at bed time
    Intervention: Drug: UMULINE NPH
  • Experimental: 2
    pioglitazone 30 mg
    Intervention: Drug: pioglitazone
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. doi: 10.1016/j.diabres.2009.06.028. Epub 2009 Aug 15.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
28
May 2007
Not Provided

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   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00159211
P031006
No
Not Provided
Not Provided
Not Provided
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