Ignite Creation Date:
2024-05-05 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00159211
Status:
TERMINATED
Last Update Posted:
2007-11-08
First Post:
2005-09-07
Brief Title:
Abdominal Adipose Tissue Distribution in Type 2 Diabetic Patients Treated During 6 Months With Pioglitazone or Insulin
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2007-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
inclusion was finished
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 45mgj or NPH bed-time insulin 02ukg
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 45mgj or NPH bed-time insulin 02ukg
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 45mgj or NPH bed-time insulin 02ukg
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 45mgj or NPH bed-time insulin 02ukg
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None