Effects of Insulin Detemir and NPH Insulin on Renal Handling of Sodium, Fluid Retention and Weight in Type 2 Diabetic Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- change in weight; change in extracellular volume
研究概览
简要总结
Hypothesis: Changing type 2 patients treatment from Insulin Insulatard to Insulin Detemir will increase their excretion of sodium in the urine and thereby decrease their extracellular volume and body weight. 24 patients are divided into 2 groups and their insulin treatment is shifted while their body composition, sodium excretion, weight and extracellular volume is monitored.
详细描述
Type 2 diabetic patients experience weight gain when receiving insulin treatment. There has been reports that the weight gain is less or absent when patients are treated with Insulin Detemir. Patients with diabetes have increased total body sodium and increased extracellular volume. We hypothesize that part of the weight gain seen is due to increase in extracellular volume and that the lesser weight gain seen in patients treated with Detemir is due to an lesser increase in extracellular volume. We believe that the cause of this difference is the different pharmacokinetic properties of insulin Detemir. Insulin Detemir i protein bound and is therefore not excreted in the kidneys. This may cause less sodium reabsorption, than with other insulins, and therefore less increase in extracellular volume.
We test this hypothesis by examining urinary sodium excretion, extracellular volume by GFR measurements, Body composition by DEXA scan, body weight, and 24 hour blood pressure.In patients that are changed from Insulin Insulatard to Insulin Detemir and back.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes according to WHO 1999 criteria for at least 3 month
- •Insulin treated for at least 1 month
- •BMI 25-40
- •Age 18-80
- •Hb1Ac < 10%
排除标准
- •Hypertension not well regulated
- •Serum creatinine > 130 micromol/l
- •Non-diabetic kidney disease
- •Disease that may cause invalid hgbA1c measurement
- •Substance abuse
- •Recent use of Detemir
- •Pregnancy or risk of becoming pregnant
- •Any condition that may disturb protocol adherence (language barrier etc) urinary albumin > 30 mg/24hours ( before screening)
- •Use of drugs that may influence blood glucose (except oral antidiabetics)
- •Use of drugs that may influence sodium balance,i.e diuretics ( tiazides accepted)
- •Clinical significant disease that may influence outcome ( cancer etc)
研究组 & 干预措施
1
8 weeks of insulin Detemir, then cross over to 8 Weeks of Insulatard, then cross over to 1 week of Detemir
干预措施: Insulin Detemir, Insulin Insulatard (Drug)
2
8 weeks of Insulin Insulatard, then cross over to 8 weeks of insulin Detemir, then crossover to 1 week of Insulin Insulatard
干预措施: Insulin Detemir; Insulin Insulatard (Drug)
2
8 weeks of Insulin Insulatard, then cross over to 8 weeks of insulin Detemir, then crossover to 1 week of Insulin Insulatard
干预措施: Insulin Detemir, Insulin Insulatard (Drug)
结局指标
主要结局
change in weight; change in extracellular volume
时间窗: 17 weeks
次要结局
- sodium excretion in urine, 24 hour blood pressure, body composition change,urine osmolality, urine albumin excretion, GFR, HbA1c, Blood lipid profile, NT-proBNP, plasma Albumin, Plasma metanephrines, aldosterone, active renin, angiotensin II(17 weeks)