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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Other: T2DM

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

• Study Type: Observational
• Enrollment (Actual): 70

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

We selected 42 T2DM patients (24 males, 18 females) without DKD as diabetes group and 38 healthy people (21 males, 17 females) as control group from the diabetic outpatient clinic in Shenyang the Fourth Hospital of People, but only 37 patients (21 males, 16 females) in the diabetes group and 33 healthy people (18 males, 15 females) can be researched in our study, all the participants were the Chinese Hans.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Diabetes group; 37 T2DM adults (diabetes group) without DKD	Other: T2DM; T2DM without DKD
Control group; 33 healthy adults (control group)	Other: T2DM; T2DM without DKD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The pulmonary function (using spirometer) in the healthy people and T2DM patients and comparing the differences between the two groups	pulmonary function parameters include: VC%, FVC%, FEV1%, PEF%, MVV%, TLC%, FEV1/FVC%, DLCO%, and DLCO/VA%	one week
The bilateral kidney RI(using CDI) in healthy people and T2DM patients and comparig the differences between the two groups	The Doppler resistance index (RI) [(peak systolic velocity, PSV - peak end diastolic velocity, PED)/ peak systolic velocity, PSV	one week
The correlation between the pulmonary function and the renal hemodynamics in 37 T2DM patients without DKD		two weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Fourth People's Hospital of Shenyang

Publications and helpful links

General Publications

• Tai H, Jiang XL, Kuang JS, Yu JJ, Ju YT, Cao WC, Chen W, Cui XY, Zhang LD, Fu X, Jia LQ, Zhang Y. Early changes in pulmonary function and intrarenal haemodynamics and the correlation between these sets of parameters in patients with T2DM. PLoS One. 2019 Dec 18;14(12):e0224923. doi: 10.1371/journal.pone.0224923. eCollection 2019.

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: May 30, 2016
• First Submitted That Met QC Criteria: June 8, 2016
• First Posted (Estimate): June 14, 2016

Study Record Updates

• Last Update Posted (Estimate): June 14, 2016
• Last Update Submitted That Met QC Criteria: June 8, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 20150908