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Clinical Trials/NCT02798198
NCT02798198
Completed
Not Applicable

The Correlation Between the Pulmonary Function and Intrarenal Hemodynamics in 37 T2DM Patients in Early Period

Fourth People's Hospital of Shenyang0 sites70 target enrollmentSeptember 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Diabetes Mellitus, Type 2
Sponsor
Fourth People's Hospital of Shenyang
Enrollment
70
Primary Endpoint
The pulmonary function (using spirometer) in the healthy people and T2DM patients and comparing the differences between the two groups
Status
Completed
Last Updated
9 years ago

Overview

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.

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

Registry
clinicaltrials.gov
Start Date
September 2015
End Date
May 2016
Last Updated
9 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Fourth People's Hospital of Shenyang
Responsible Party
Principal Investigator
Principal Investigator

Jin-song Kuang

Chief physician

Fourth People's Hospital of Shenyang

Eligibility Criteria

Inclusion Criteria

  • 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

  • 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.

Outcomes

Primary Outcomes

The pulmonary function (using spirometer) in the healthy people and T2DM patients and comparing the differences between the two groups

Time Frame: 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

Time Frame: 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

Time Frame: two weeks

Secondary Outcomes

  • 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)

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