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.
Overview
- Phase
- Not Applicable
- Intervention
- UMULINE NPH
- Conditions
- Type 2 Diabetes
- Sponsor
- Assistance Publique - Hôpitaux de Paris
- Enrollment
- 28
- Locations
- 1
- Primary Endpoint
- Abdominal adipose tissue (on scan) variation at 6 month
- Status
- Terminated
- Last Updated
- 18 years ago
Overview
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/
Investigators
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
Arms & Interventions
1
UMULINE NPH at bed time
Intervention: UMULINE NPH
2
pioglitazone 30 mg
Intervention: pioglitazone
Outcomes
Primary Outcomes
Abdominal adipose tissue (on scan) variation at 6 month
Time Frame: 6 months
Secondary Outcomes
- Cellularity of subcutaneous adipose variation tissue at 6 month(6 months)
- HbA1c, lipid level, adiponectin, CRP variation at 6 month(6 months)
- inflammation gene expression in sub-cutaneous fat(6 months)