Abdominal Adipose Tissue Distribution in Type 2 Diabetic Patients Treated During 6 Months With Pioglitazone or Insulin
Primary Purpose
Type 2 Diabetes
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
UMULINE NPH
pioglitazone
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes focused on measuring type 2 diabetes
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
Sites / Locations
- Sce de Diabétologie, hôpital de la Pitié-salpêtrière, 83bld de l'hôpital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
1
2
Arm Description
UMULINE NPH at bed time
pioglitazone 30 mg
Outcomes
Primary Outcome Measures
Abdominal adipose tissue (on scan) variation at 6 month
Secondary Outcome Measures
Cellularity of subcutaneous adipose variation tissue at 6 month
HbA1c, lipid level, adiponectin, CRP variation at 6 month
inflammation gene expression in sub-cutaneous fat
Full Information
NCT ID
NCT00159211
First Posted
September 7, 2005
Last Updated
November 6, 2007
Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Laboratoires Takeda
1. Study Identification
Unique Protocol Identification Number
NCT00159211
Brief Title
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
2. Study Status
Record Verification Date
April 2007
Overall Recruitment Status
Terminated
Why Stopped
inclusion was finished
Study Start Date
May 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Laboratoires Takeda
4. Oversight
Data Monitoring Committee
No
5. Study Description
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/
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
type 2 diabetes
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
UMULINE NPH at bed time
Arm Title
2
Arm Type
Experimental
Arm Description
pioglitazone 30 mg
Intervention Type
Drug
Intervention Name(s)
UMULINE NPH
Intervention Description
UMULINE NPH at bed time with a increasing dose up to get a fasting glycemia under 1.1 g/l
Intervention Type
Drug
Intervention Name(s)
pioglitazone
Intervention Description
30mg daily. After 2 months, if HbA1c has not decreased at least of 1%, the dosage should be increased to 45 mg daily
Primary Outcome Measure Information:
Title
Abdominal adipose tissue (on scan) variation at 6 month
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Cellularity of subcutaneous adipose variation tissue at 6 month
Time Frame
6 months
Title
HbA1c, lipid level, adiponectin, CRP variation at 6 month
Time Frame
6 months
Title
inflammation gene expression in sub-cutaneous fat
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Agnès Hartemann-Heurtier, MDPHD
Organizational Affiliation
Assistance Publique des Hôpitaux de Paris Hôpital Pitié Salpêtrière France
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sce de Diabétologie, hôpital de la Pitié-salpêtrière, 83bld de l'hôpital
City
Paris
ZIP/Postal Code
75013
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
19683825
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.
Results Reference
derived
Learn more about this trial
Abdominal Adipose Tissue Distribution in Type 2 Diabetic Patients Treated During 6 Months With Pioglitazone or Insulin
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