Beijing Chao-Yang Hospital, Capital Medical University
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 230
- 主要终点
- The change of HbA1c
研究概览
简要总结
The present study assessed the therapeutic effect of exenatide and metformin as the initial therapy in overweight/obese patients with newly diagnosed Type 2 diabetes (T2D).
详细描述
The present study was a prospective, nonrandomized, interventional study.The drug-naïve, overweight or obese patients with newly diagnosed T2D were consecutively enrolled. The inclusion criteria: 1) age 20 - <65 years, 2) body mass index (BMI) ≥ 24 kg/m2 [7], and 3) HbA1c ≥ 7% (53mmol/mol). An oral glucose tolerance test was performed during the screenings. All of the patients have no diabetes antibodies and were diagnosed with T2D within the previous 3 months, according to the ADA diagnostic criteria. None of the patients had administered anti-diabetic drugs or diet therapy before participation. Neither of the patients presented any history of pancreatitis, coronary artery disease, liver function impairment, renal function impairment, intestinal surgery, chronic hypoxic diseases (emphysema and cor pulmonale), infectious disease, hematological disease, systemic inflammatory disease, or cancer. Patients who were pregnant, possibly pregnant, or ingesting agents known to influence glucose or lipid metabolism were also excluded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 20 - <65 years,
- •body mass index (BMI) ≥ 24 kg/m2,
- •HbA1c ≥ 7% (53mmol/mol).
- •diabetes antibodies (-)
- •diagnosed with T2D within the previous 3 months
排除标准
- •anti-diabetic drugs or diet therapy before participation
- •pancreatitis
- •coronary artery disease
- •liver function impairment
- •renal function impairment
- •intestinal surgery
- •chronic hypoxic diseases (emphysema and cor pulmonale)
- •infectious disease
- •hematological disease
- •systemic inflammatory disease
- •pregnant, possibly pregnant
- •ingesting agents known to influence glucose or lipid metabolism
研究组 & 干预措施
exenatide group
The drug-naïve, overweight or obese patients with newly diagnosed T2D
干预措施: Exenatide or metformin hydrochloride (Drug)
metformin group
The drug-naïve, overweight or obese patients with newly diagnosed T2D
干预措施: Exenatide or metformin hydrochloride (Drug)
结局指标
主要结局
The change of HbA1c
时间窗: baseline and 12 weeks
次要结局
未报告次要终点
研究者
Guang Wang
Director of Endocrinology,Principal Investigator
Beijing Chao Yang Hospital
