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

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.

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

Overall Status Completed
Start Date September 2015
Completion Date May 2016
Primary Completion Date May 2016
Study Type Observational
Primary Outcome
Measure Time Frame
The pulmonary function (using spirometer) in the healthy people and T2DM patients and comparing the differences between the two groups one week
The bilateral kidney RI(using CDI) in healthy people and T2DM patients and comparig the differences between the two groups one week
The correlation between the pulmonary function and the renal hemodynamics in 37 T2DM patients without DKD two weeks
Secondary Outcome
Measure Time Frame
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
Enrollment 70
Condition
Intervention

Intervention Type: Other

Intervention Name: T2DM

Description: T2DM without DKD

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

Verification Date

May 2016

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Fourth People's Hospital of Shenyang

Investigator Full Name: Jin-song Kuang

Investigator Title: Chief physician

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)

Study Design Info

Observational Model: Case Control

Time Perspective: Cross-Sectional

Source: ClinicalTrials.gov