Is it Time to Revise Type 2 Diabetes Treatment: C-peptide Concentrations in Type 2 Diabetes Treated With Insulin
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 249
- 试验地点
- 1
- 主要终点
- The incidence of adequate, borderline and insufficient beta cell reserves assessed by the fasting C-peptide concentrations
研究概览
简要总结
C-peptide is used to evaluate beta cell reserves. Patients with type 2 diabetes are treated with insulin for different indications. Other than beta-cell insufficiency and organ failures, insulin treatment is needed for a specified period. The investigators want to evaluate beta cell reserves in patients with type 2 diabetes treated with insulin for at least six months to see if that is the case. The investigators also want to compare the characteristics of these patients according to their beta cell reserves.
详细描述
In patients with type 2 diabetes, initiation of insulin therapy is indicated in several conditions such as severe insulin resistance, acute metabolic decompensations, surgery, pregnancy, and progression of diabetic complications, and also when glycemic control cannot be achieved with effective lifestyle regulation and non-insulin antidiabetic medications. Some of these indications are transient, and patients should be reassessed to choose the appropriate treatment options. Clinical inertia is one of the new topics expressed in the recent diabetes guidelines. The investigators aimed to investigate the beta cell reserves of the patients with type 2 diabetes who are treated with insulin, to see if they have insufficient insulin secretion and if not, to compare their characteristics.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with type 2 diabetes who had been treated with insulin as a monotherapy or as a component of combination therapy for at least 6 months.
排除标准
- •Diagnosis of other types of diabetes,
- •end-stage renal failure,
- •history of renal transplantation,
- •diabetic acute metabolic decompensation,
- •decompensated heart failure,
- •advanced liver disease,
- •pregnancy,
- •acute or chronic pancreatitis,
- •pancreatic carcinoma,
- •acute infections,
- •use of medications that might affect glucose regulation (e.g. corticosteroids)
结局指标
主要结局
The incidence of adequate, borderline and insufficient beta cell reserves assessed by the fasting C-peptide concentrations
时间窗: 3 months
Fasting C-peptide concentrations will be measured in patients with type 2 diabetic patients using insulin as a monotherapy or as part of combination therapy and the patients will be grouped as patients with adequate beta cell reserves, patients with borderline beta cell reserves and patient with insufficient beta cell reserves.
Correlations of fasting C-peptide concentrations with patients characteristics and biochemical findings
时间窗: 3 months
Correlations of fasting C-peptide concentrations with patients characteristics and biochemical findings, especially the components of metabolic syndrome.
次要结局
未报告次要终点
研究者
Ayse N Erbakan
Principal Investigator
Goztepe Training and Research Hospital