The Correlation Between the Pulmonary Function and Intrarenal Hemodynamics in 37 T2DM Patients in Early Period
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 主要终点
- The pulmonary function (using spirometer) in the healthy people and T2DM patients and comparing the differences between the two groups
研究概览
简要总结
Objective: The main target of this study was to research the early changes in pulmonary function and intrarenal hemodynamics, then research the correlation between the pulmonary function and the renal hemodynamics in type 2 diabetes (T2DM) patients without diabetic kidney disease (DKD).
Method: 37 T2DM patients (diabetes group) without DKD and 33 healthy people (control group) were choosed to research early changes in pulmonary function and intrarenal hemodynamics, then research the correlation between the pulmonary function and the renal blood flow in T2DM patients, all having normal renal function. The primary endpoints were the pulmonary function parameters (VC%, FVC%, FEV1%, PEF%, MVV%, TLC%, FEV1/FVC%, DLCO%, and DLCO/VA%); the secondary endpoints were the intrarenal hemodynamic (bilateral kidney RI) in bilateral interlobular renal arteries were evaluated using; the tertiary endpoints were the biochemical variables: blood-fat (TC, HDL-C, LDL-C, and TG), renal function parameters (BUN, Cr, and GFR); in addition, the albumin excrete rate (AER), urinary albumin/creatinine ratio (UACR) were measured.
详细描述
Pulmonary function was measured by spirometer which was provided by Jaska Corporation in Japan, model number: HI-101; RI were measured by Logiq 400 MD Pro Series scanner (GE Medical Systems, Milwaukee, WI) using a 3.5-4 MHz vector array transducer
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 35 Years 至 66 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The patients were diagnosed with T2DM according to the guidelines of the American Diabetes Association ; 2) No smoking history, pulmonary disease, cold, nor pulmonary infection within a fortnight; 3) Did not have hepatopathy, nephropathy, hyperuricemia, and gastrointestinal disease; and 4) Likely to have good compliance and able to visit our hospital for periodic assessments.
排除标准
- •T1DM, gestation and lactation; 2) Renal inadequacy; 3) Hypohepatia; 4) Intensive care with insulin treatment; 5) The patients combinated with DKD and hypertension (antihypertensive drugs were used); 6) Patients with other renal conditions that could affect the hemodynamics, such as urolithiasis, urinary infection, and renal cyst (diameter > 3 cm); 7) Heart failure; 8) Cholesterol-lowering drugs can not control the blood-fat ; and 9) Use of systemically injected glucocorticoids within 3 months prior to our study.
结局指标
主要结局
The pulmonary function (using spirometer) in the healthy people and T2DM patients and comparing the differences between the two groups
时间窗: one week
pulmonary function parameters include: VC%, FVC%, FEV1%, PEF%, MVV%, TLC%, FEV1/FVC%, DLCO%, and DLCO/VA%
The bilateral kidney RI(using CDI) in healthy people and T2DM patients and comparig the differences between the two groups
时间窗: one week
The Doppler resistance index (RI) \[(peak systolic velocity, PSV - peak end diastolic velocity, PED)/ peak systolic velocity, PSV
The correlation between the pulmonary function and the renal hemodynamics in 37 T2DM patients without DKD
时间窗: two weeks
次要结局
- Blood-fat (TC, HDL-C, LDL-C, and TG)in the healthy people and T2DM patients and comparing the differences between the two groups(Three weeks)
- Renal function parameters (BUN, Cr) in the healthy people and T2DM patients and comparing the differences between the two groups(Three weeks)
- The albumin excrete rate (AER), urinary albumin/creatinine ratio (UACR)in the healthy people and T2DM patients and comparing the differences between the two groups(Three weeks)
研究者
Jin-song Kuang
Chief physician
Fourth People's Hospital of Shenyang