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/
Primary Outcome Measures:
- Abdominal adipose tissue (on scan) variation at 6 month [ Time Frame: 6 months ]
Secondary Outcome Measures:
- 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 ]
| Enrollment: |
28 |
| Study Start Date: |
May 2005 |
| Study Completion Date: |
May 2007 |
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1: Active Comparator
UMULINE NPH at bed time
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Drug: UMULINE NPH
UMULINE NPH at bed time with a increasing dose up to get a fasting glycemia under 1.1 g/l
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2: Experimental
pioglitazone 30 mg
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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
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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/
Purpose
