Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06344000
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-03
First Post:
2024-03-25
Brief Title:
Study on Disease Progression and Nutritional Status in Bronchiectasis
Sponsor:
Wuhan Union Hospital China
Organization:
Wuhan Union Hospital China
Study Overview
Official Title:
A Study of the Association Between Progression and Nutritional Status in Bronchiectasis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Bronchiectasis is a common lung disease The Bronchiectasis Severity Index BSI is a widely used assessment system The body mass index BMI is a commonly used measure of nutritional status but it has its limitations To provide a more comprehensive assessment the investigators also consider other nutrition-related indices such as upper arm circumference calf circumference skinfold thickness and grip strength The investigators will specify the relationship between nutritional status and disease progression by measuring nutrition-related indicators and tracking participants disease progression
Detailed Description:
Non-cystic fibrosis bronchiectasis is a common lung disease in which low body weight and BMI are in more common The prevalence of malnutrition is higher in bronchiectasis compared to other lung diseases A study on the assessment of nutritional status in end-stage lung disease noted a higher prevalence of malnutrition in patients with CF or NCFB according to the GLIM framework Therefore nutritional status is a condition of concern in patients with non-cystic fibrosis bronchiectasis The Bronchiectasis Severity Score BSI of which BMI is a component is a useful prognostic measure and it is reasonable to assume that BMI correlates with the severity of bronchiectasisBMI is an easily accessible nutrition-related criterion and many studies have been conducted on the correlation between BMI and prognosis including hospitalisation in patients with bronchiectasis It has been shown that BMI is an independent predictor of hospitalisation and that patients with lower BMI are more likely to have acute exacerbations worsening lung function increased systemic inflammation and chronic colonisation by Pseudomonas aeruginosa It has now been shown that reduced muscle mass in patients with lower nutritional status especially fat-free mass index is thought to contribute to worsening lung function in patients with COPD This phenomenon may still be present in patients with bronchiectasisBMI a commonly used body measure in clinical practice is easy to obtain but does not adequately reflect the nutritional status of the participants so the researchers included new nutritional parameters such as upper arm circumference calf circumference grip strength skinfold thickness upper arm muscle circumference and defatted body mass index in order to comprehensively assess the nutritional status of the patients and to clarify the relationship between nutritional status and bronchiectasis correlation between nutritional status and the presence of prognosis in bronchiectasis According to the inclusion and exclusion criteria participants with confirmed diagnosis of bronchiectasis attending the Union Hospital of Tongji Medical College of Huazhong University of Science and Technology from 31 March 2024 to 31 March 2027 will be included in this study At the time of enrolment the researchers collected the demographic information of the participants such as gender age measurement of their height m weight kg skinfold thickness including triceps brachii back and abdomen mm upper arm circumference cm calf circumference cm grip strength average of two measurements in kilograms using a grip strength meter and data from bioelectrical impedance analysis phase angle phA total fat mass FM fat-free mass FFM skeletal muscle mass SMM and blood test results such as red blood cell count 1012l haemoglobin gl triglycerides mmoll LDL cholesterol mmoll HDL cholesterol mmoll and blood glucose mmoll were collected from the participants blood tests at the time of their visit The results of pulmonary function tests such as the patients FEV1 and FEV1 as a percentage of the expected value and imaging tests of the lungs such as CT were also used to calculate the patients nutrition-related indices such as BMI kgm2 fat-free mass index FFMi and the patients nutrition-related indices such as BMI kgm2 and FFMi FFMi free mass index FFMi and skeletal muscle mass index SMMi and the participants PNI index CONUT index HALP index GNRI index GPS index and Bhalla Scoring After enrolment the participants were grouped into malnourished and non-malnourished groups according to the GLIM criteria based on the nutritional status of the patients Over the next three years the patients were followed up every six months to obtain the above nutritional indices pulmonary function and lung CT results as well as the number of acute exacerbations the number of hospitalisations and the survival status of the patients per year in order to conclude the relationship between nutritional status and the progression of bronchiectasis
Methods Height weight upper arm circumference calf circumference and waist circumference were determined while the patients were fasting and wearing only light clothing Waist circumference was determined to the nearest 01 cm Waist circumference was measured just above the ilium using flexible plastic measuring tape Upper arm circumference is measured at the triceps belly Calf circumference is measured at the quadriceps bellyBody height in meters was measured using a normal height scale and body weight was determined using digital devices BMI was determined using the following formula body weight in kilograms divided by body height in meters squared
Handgrip strength was measured on three separate occasions This was performed with the patient seated on a chair with their shoulder and forearm in a neutral position and the elbow at 90 degrees of flexion The participant performed a maximum grip force for 3 s and rested for 1 min between each repetition
Total fat mass and total fat-free mass were determined via bioelectrical impedance BIA analysis with a total accuracy of 50 g The bioelectrical impedance analysis was performed in a standardized manner with the patient fasting for 8 h and resting for 30 min The electrodes were placed distally on the wrists and ankles of the patients with the patients in a supine position and having assumed a lying position 30 min beforehand Absolute fat-free mass FFM and skeletal muscle mass SMM were determined directly via impedance Then FFMi fat-free mass index was determined by dividing absolute FFM by squared height FFM kgheight m2 SMMi skeletal muscle mass index was also determined by dividing SMM by squared height Subjects were separated into 2 groups according to their median SMMi values
The CONUT score was calculated from the results of three laboratory tests including serum albumin level total lymphocyte count and cholesterol level The calculation formula of the PNI score was as follows 10serum albumin level gdL 0005 total lymphocyte count numbermm3 The GNRI score was calculated as 1489 serum albumin level gdL 417 current weightideal weight and the ideal weight was calculated as 22 height squared The HALP score is calculated as HALP Score hemoglobin gL albumin gL lymphocytes Lplatelets LThe Glasgow prognostic score GPS is evaluated using serum CRP and albumin levelsLung CT scores were scored according to the Bhalla scoring criteria and were co-scored by two medical imaging physicians
Statistical analysis and statistical methods The data obtained during the study were pre-collated For continuous data normality tests were first performed If all groups met normality the Students t-test was used for comparison between groups Otherwise the non-parametric Wilcoxon rank sum test was considered For categorical variables the χ2 test was used Statistically significant data were subjected to multivariate logistic regression analysis Receiver operating characteristic ROC and Delongs method were used to analyze the effect of different nutritional status on the prognosis of participants with bronchiectasiswith a difference considered statistically significant at P 005
Statistical analysis of all data was performed through SPSS IBM SPSS Statistics 260 SPSS Inc Chicago IL and R language version 413 wwwR-projectorg All statistical tests were two-sided and statistical significance was set at 005
Methods Height weight upper arm circumference calf circumference and waist circumference were determined while the patients were fasting and wearing only light clothing Waist circumference was determined to the nearest 01 cm Waist circumference was measured just above the ilium using flexible plastic measuring tape Upper arm circumference is measured at the triceps belly Calf circumference is measured at the quadriceps bellyBody height in meters was measured using a normal height scale and body weight was determined using digital devices BMI was determined using the following formula body weight in kilograms divided by body height in meters squared
Handgrip strength was measured on three separate occasions This was performed with the patient seated on a chair with their shoulder and forearm in a neutral position and the elbow at 90 degrees of flexion The participant performed a maximum grip force for 3 s and rested for 1 min between each repetition
Total fat mass and total fat-free mass were determined via bioelectrical impedance BIA analysis with a total accuracy of 50 g The bioelectrical impedance analysis was performed in a standardized manner with the patient fasting for 8 h and resting for 30 min The electrodes were placed distally on the wrists and ankles of the patients with the patients in a supine position and having assumed a lying position 30 min beforehand Absolute fat-free mass FFM and skeletal muscle mass SMM were determined directly via impedance Then FFMi fat-free mass index was determined by dividing absolute FFM by squared height FFM kgheight m2 SMMi skeletal muscle mass index was also determined by dividing SMM by squared height Subjects were separated into 2 groups according to their median SMMi values
The CONUT score was calculated from the results of three laboratory tests including serum albumin level total lymphocyte count and cholesterol level The calculation formula of the PNI score was as follows 10serum albumin level gdL 0005 total lymphocyte count numbermm3 The GNRI score was calculated as 1489 serum albumin level gdL 417 current weightideal weight and the ideal weight was calculated as 22 height squared The HALP score is calculated as HALP Score hemoglobin gL albumin gL lymphocytes Lplatelets LThe Glasgow prognostic score GPS is evaluated using serum CRP and albumin levelsLung CT scores were scored according to the Bhalla scoring criteria and were co-scored by two medical imaging physicians
Statistical analysis and statistical methods The data obtained during the study were pre-collated For continuous data normality tests were first performed If all groups met normality the Students t-test was used for comparison between groups Otherwise the non-parametric Wilcoxon rank sum test was considered For categorical variables the χ2 test was used Statistically significant data were subjected to multivariate logistic regression analysis Receiver operating characteristic ROC and Delongs method were used to analyze the effect of different nutritional status on the prognosis of participants with bronchiectasiswith a difference considered statistically significant at P 005
Statistical analysis of all data was performed through SPSS IBM SPSS Statistics 260 SPSS Inc Chicago IL and R language version 413 wwwR-projectorg All statistical tests were two-sided and statistical significance was set at 005
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None