The Correlation Between the Pulmonary Function and Intrarenal Hemodynamics in 37 T2DM Patients in Early Period
Sponsors
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
2015-09-01
Completion Date
2016-05-01
Primary Completion Date
2016-05-01
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 |
Number Of Groups
2
Enrollment
70
Condition
Intervention
Intervention Type
Other
Intervention Name
Description
T2DM without DKD
Arm Group Label
Diabetes group
Control group
Eligibility
Study Pop
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.
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
2016-05-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
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
Arm Group Label
Diabetes group
Description
37 T2DM adults (diabetes group) without DKD
Arm Group Label
Control group
Description
33 healthy adults (control group)
Firstreceived Results Date
N/A
Firstreceived Results Disposition Date
N/A
Study Design Info
Observational Model
Case Control
Time Perspective
Cross-Sectional
Study First Submitted
May 30, 2016
Study First Submitted Qc
June 8, 2016
Study First Posted
June 14, 2016
Last Update Submitted
June 8, 2016
Last Update Submitted Qc
June 8, 2016
Last Update Posted
June 14, 2016
ClinicalTrials.gov processed this data on December 06, 2019
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.