Abdominal Adipose Tissue Distribution in Type 2 Diabetic Patients Treated During 6 Months With Pioglitazone or Insulin
- Registration Number
- NCT00159211
- Lead Sponsor
- Assistance Publique - Hôpitaux de Paris
- 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/
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 28
- Type 2 diabetes
- BMI= 26kg/m2
- Maximal treatment with metformin and sulfonylurea
- HbA1c between 7.5 and 9.5%
- Anterior treatment with glitazones
- Anterior treatment with insulin
- Known heart failure
- Hepatopathy
- Renal filtration less than 60ml/min, Hb<10g/dl
- Corticoids treatment
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 UMULINE NPH UMULINE NPH at bed time 2 pioglitazone pioglitazone 30 mg
- Primary Outcome Measures
Name Time Method Abdominal adipose tissue (on scan) variation at 6 month 6 months
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Sce de Diabétologie, hôpital de la Pitié-salpêtrière, 83bld de l'hôpital
🇫🇷Paris, France