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.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Abdominal adipose tissue (on scan) variation at 6 month
研究概览
简要总结
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/
详细描述
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/
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes
- •BMI= 26kg/m2
- •Maximal treatment with metformin and sulfonylurea
- •HbA1c between 7.5 and 9.5%
排除标准
- •Anterior treatment with glitazones
- •Anterior treatment with insulin
- •Known heart failure
- •Hepatopathy
- •Renal filtration less than 60ml/min, Hb<10g/dl
- •Corticoids treatment
研究组 & 干预措施
1
UMULINE NPH at bed time
干预措施: UMULINE NPH (Drug)
2
pioglitazone 30 mg
干预措施: pioglitazone (Drug)
结局指标
主要结局
Abdominal adipose tissue (on scan) variation at 6 month
时间窗: 6 months
次要结局
- 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)