Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00159211
Recruitment Status : Terminated (inclusion was finished)
First Posted : September 12, 2005
Last Update Posted : November 8, 2007
Sponsor:
Collaborator:
Laboratoires Takeda
Information provided by:
Assistance Publique - Hôpitaux de Paris

Tracking Information
First Submitted Date  ICMJE September 7, 2005
First Posted Date  ICMJE September 12, 2005
Last Update Posted Date November 8, 2007
Study Start Date  ICMJE May 2005
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: November 6, 2007)
Abdominal adipose tissue (on scan) variation at 6 month [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 7, 2005)
Abdominal adipose tissue (on scan) variation at 6 month
Change History Complete list of historical versions of study NCT00159211 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 6, 2007)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 7, 2005)
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Abdominal Adipose Tissue Distribution in Type 2 Diabetic Patients Treated During 6 Months With Pioglitazone or Insulin
Official Title  ICMJE 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.
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/

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Type 2 Diabetes
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Active Comparator: 1
    UMULINE NPH at bed time
    Intervention: Drug: UMULINE NPH
  • Experimental: 2
    pioglitazone 30 mg
    Intervention: Drug: pioglitazone
Publications * 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.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: November 6, 2007)
28
Original Enrollment  ICMJE
 (submitted: September 7, 2005)
48
Actual Study Completion Date  ICMJE May 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 35 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00159211
Other Study ID Numbers  ICMJE P031006
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Assistance Publique - Hôpitaux de Paris
Collaborators  ICMJE Laboratoires Takeda
Investigators  ICMJE
Principal Investigator: Agnès Hartemann-Heurtier, MDPHD Assistance Publique des Hôpitaux de Paris Hôpital Pitié Salpêtrière France
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date April 2007

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