Effect of Acute Angiotensin Receptor Blockade on Insulin Resistance and Selected Cytokines in Adipose Tissue in Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- insulin sensitivity measured as glucose disposal during clamp
研究概览
简要总结
The study aims to investigate the effect of acute angiotensin receptor blockade on insulin action/insulin resistance and expressions of selected adipocytokines in subcutaneous adipose tissue in insulin-resistant subjects with type 2 diabetes and healthy controls.
Hypothesis: Changes in adipocytokine concentrations and/or expressions and different reactions to acute in vivo induced hyperinsulinemia and angiotensin receptor blockade will be found in patients with type 2 diabetes compared to healthy subjects. A significant relationships between insulin sensitivity and selected adipokines and intracellular fat content and high energy phosphates in soleus muscle will be documented in healthy individuals, while no significant relation will be found in patients with type 2 diabetes.
详细描述
10-15 patients with type 2 diabetes and 10-15 healthy control subjects will be examined on an outpatient basis. The following examination will be carried out in each subject after 12 hrs fasting:
- Oral glucose tolerance test (75 g of glucose) (in healthy subjects to confirm the normal tolerance of glucose).
- Evaluation of insulin secretion after 1 mg of glucagon i.v.
- Hyperinsulinaemic (75 milly-international unit(mIU)/l) euglycemic clamp study lasting 4 hours combined with indirect calorimetry and biopsy of subcutaneous adipose tissue.
- Hyperinsulinemic (75 mIU/l) euglycemic clamp study lasting 4 hours combined with indirect calorimetry after losartan 100 mg given in the evening and in the morning before the study.
- Proton and phosphorus magnetic resonance spectroscopy.
Before (0 min), at 30 min and in the end of studies c) and d) the blood samples will be taken and biopsies of subcutaneous abdominal adipose tissue will be done.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Type 2 Diabetes treated with oral agents and/or diet
- •Healthy volunteers age- and sex-matched to type 2 diabetes, without any concomitant disease
排除标准
- •Type 2 Diabetes
- •treated with insulin
- •clinical evidence of atherosclerotic complications
- •advanced long-term diabetic complications (manifest nephropathy, proliferative retinopathy)
- •other internal disease
- •weight change >10% 3 months prior to study
- •Healthy volunteers
- •fulfilling the criteria of metabolic syndrome
- •weight change >10% 3 months prior to study
研究组 & 干预措施
Hyperinsulinaemia
Hyperinsulinaemic (1 mIU/kg/min) euglycaemic (5 mmol/l) clamp
干预措施: Hyperinsulinaemia (Procedure)
Losartan + hyperinsulinaemia
干预措施: Hyperinsulinaemia (Procedure)
Losartan + hyperinsulinaemia
干预措施: Losartan (Drug)
Saline
Infusion of Saline as a volume control intervention
干预措施: Saline (Drug)
结局指标
主要结局
insulin sensitivity measured as glucose disposal during clamp
时间窗: 4 hours
次要结局
- plasma adipokines and their expressions in SAT(at 0 and 240 min of the clamp)