The Correlation Between the Pulmonary Function and Intrarenal Hemodynamics in 37 T2DM Patients in Early Period
| Sponsors |
Lead Sponsor: Fourth People's Hospital of Shenyang |
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| Source | Fourth People's Hospital of Shenyang | ||||||||
| Brief Summary | 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. |
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| Detailed Description | 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 |
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| Overall Status | Completed | ||||||||
| Start Date | September 2015 | ||||||||
| Completion Date | May 2016 | ||||||||
| Primary Completion Date | May 2016 | ||||||||
| Study Type | Observational | ||||||||
| Primary Outcome |
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| Secondary Outcome |
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| Enrollment | 70 | ||||||||
| Condition | |||||||||
| Intervention |
Intervention Type: Other Intervention Name: T2DM Description: T2DM without DKD |
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| Eligibility |
Sampling Method: Non-Probability Sample
Criteria:
Inclusion Criteria: 1) 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. Exclusion Criteria: 1) 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. Gender: All Minimum Age: 35 Years Maximum Age: 66 Years Healthy Volunteers: Accepts Healthy Volunteers |
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| Verification Date |
May 2016 |
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| Responsible Party |
Type: Principal Investigator Investigator Affiliation: Fourth People's Hospital of Shenyang Investigator Full Name: Jin-song Kuang Investigator Title: Chief physician |
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| Has Expanded Access | No | ||||||||
| Condition Browse | |||||||||
| Arm Group |
Label: Diabetes group Description: 37 T2DM adults (diabetes group) without DKD Label: Control group Description: 33 healthy adults (control group) |
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| Study Design Info |
Observational Model: Case Control Time Perspective: Cross-Sectional |
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