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

NCT02798198 | Completed

• 1 other identifier: 20150908
• Study Type: observational
• Target: 70
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• 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

Study Arms (2)

Diabetes group

37 T2DM adults (diabetes group) without DKD

Other: T2DM

Control group

33 healthy adults (control group)

Other: T2DM

Interventions

T2DM OTHER

T2DM without DKD

Control group; Diabetes group

Eligibility Criteria

• Age: 35 Years - 66 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• \) 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.

You may not qualify if:

• \) 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.

Sponsors & Collaborators

• Fourth People's Hospital of Shenyang: lead

Related Publications (1)

• 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.

  PMID: 31851677 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: May 30, 2016
• First Posted: June 14, 2016
• Study Start: September 1, 2015
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: June 14, 2016

Record last verified: 2016-05