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Completed

NCT Number: NCT02798198

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

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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Key information

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

T2DM

Other

T2DM without DKD

Primary outcomes

  1. 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%

  2. 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

  3. The correlation between the pulmonary function and the renal hemodynamics in 37 T2DM patients without DKD

    Time frame: two weeks

Secondary outcomes

  1. Blood-fat (TC, HDL-C, LDL-C, and TG)in the healthy people and T2DM patients and comparing the differences between the two groups

    Time frame: Three weeks

  2. Renal function parameters (BUN, Cr) in the healthy people and T2DM patients and comparing the differences between the two groups

    Time frame: Three weeks

  3. 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

    Time frame: Three weeks

Sponsors and collaborators

Lead sponsor

Fourth People's Hospital of Shenyang

Other

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jun 14, 2016
Registry last updated
Jun 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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