Clinical trial NCT02798198: The Correlation Between the Pulmonary Function and Intrarenal Hemodynamics in 37 T2DM Patients in Early Period
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Fourth People's Hospital of Shenyang
Sponsor class: OTHER
First posted: 2016-06-14
Enrollment: 70
Sex: ALL
Minimum age (years): 35
Maximum age (years): 66
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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.

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

Eligibility 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.

Primary outcomes:
measure: The pulmonary function (using spirometer) in the healthy people and T2DM patients and comparing the differences between the two groups
timeFrame: one week
measure: The bilateral kidney RI(using CDI) in healthy people and T2DM patients and comparig the differences between the two groups
timeFrame: one week
measure: The correlation between the pulmonary function and the renal hemodynamics in 37 T2DM patients without DKD
timeFrame: two weeks
Secondary outcomes:
measure: Blood-fat (TC, HDL-C, LDL-C, and TG)in the healthy people and T2DM patients and comparing the differences between the two groups
timeFrame: Three weeks
measure: Renal function parameters (BUN, Cr) in the healthy people and T2DM patients and comparing the differences between the two groups
timeFrame: Three weeks
measure: 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
timeFrame: Three weeks
Other outcomes:
Locations:
Study officials:
References:
citation: 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.