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
    Other Name: UMULINE NPH
  • 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
    Other Name: pioglitazone
  • 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. 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
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00159211
P031006
No
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