Role of NLRP3 Inflammasone and Hypoxia in the Severity of Osteoporosis in Patients With Bronchiectasis

NCT03467035 | Unknown

• 1 other identifier: 201701317A3
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The objectives of this research grant are to determine the association of hypoxia with the severity of osteoporosis in the patients with bronchiectasis and whether the mechanism of inflammation is triggered by inflammasones, which makes it more prone to osteoporosis in patients with bronchiectasis.

Conditions

Bronchiectasis Adult; Osteoporosis, Osteopenia

Outcome Measures

Primary Outcomes (1)

• six minute walk test

  six minute walk test distance

  6 months

Study Arms (2)

desaturation

ΔSpO2 \>10% or lowest SpO2\<90 during baseline six minute walk test Check serum level of inflammasone, such as IL-1beta, TGF-beta TRT-PCR for PBMC

Other: Inflammasone

non-desaturation

ΔSpO2 \<10% and lowest SpO2\>90 during baseline six minute walk test Check serum level of inflammasone, such as IL-1beta, TGF-beta TRT-PCR for PBMC

Other: Inflammasone

Interventions

Inflammasone OTHER

Serum level of cytokine and RT-PCR for PBMC

desaturation; non-desaturation

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

80 adult patients with proven bronchiectasis, diagnosed by high-resolution computed tomography (HRCT), will be recruited from our outpatient clinic of Chang Gung Memorial Hospital with written informed consent. The inclusion and exclusion criteria are described above.

You may qualify if:

• willing to sign a written consent form
• Male and female subjects with bronchiectasis diagnosed by high-resolution computed tomography
• willing to accept 6-minute exercise pulmonary function test and blood draw
• Men and women over the age of 20
• Has undergone chest computed tomography and bone density examination in the recent five years

You may not qualify if:

• pregnant women or lactating women
• asthma, lung resection history before the screening period
• active Tuberculosis infection
• Have received oral steroid treatment within 30 days
• current acute attack or clinical symptoms instability of bronchiectasis

Sponsors & Collaborators

• Chun-Hua Wang, MD: lead

Study Sites (1)

Chang Gung Memorial Hospital

Taipei, 333, Taiwan

RECRUITING

Related Publications (6)

• Cole PJ. Inflammation: a two-edged sword--the model of bronchiectasis. Eur J Respir Dis Suppl. 1986;147:6-15.

  PMID: 3533593 BACKGROUND

• Arnett TR. Acidosis, hypoxia and bone. Arch Biochem Biophys. 2010 Nov 1;503(1):103-9. doi: 10.1016/j.abb.2010.07.021. Epub 2010 Jul 23.

  PMID: 20655868 BACKGROUND

• Utting JC, Flanagan AM, Brandao-Burch A, Orriss IR, Arnett TR. Hypoxia stimulates osteoclast formation from human peripheral blood. Cell Biochem Funct. 2010 Jul;28(5):374-80. doi: 10.1002/cbf.1660.

  PMID: 20556743 BACKGROUND

• Kim RY, Pinkerton JW, Gibson PG, Cooper MA, Horvat JC, Hansbro PM. Inflammasomes in COPD and neutrophilic asthma. Thorax. 2015 Dec;70(12):1199-201. doi: 10.1136/thoraxjnl-2014-206736. Epub 2015 Oct 22. No abstract available.

  PMID: 26493990 BACKGROUND

• Diehl N, Johnson MM. Prevalence of Osteopenia and Osteoporosis in Patients with Noncystic Fibrosis Bronchiectasis. South Med J. 2016 Dec;109(12):779-783. doi: 10.14423/SMJ.0000000000000565.

  PMID: 27911973 BACKGROUND

• McDonnell MJ, Aliberti S, Goeminne PC, Restrepo MI, Finch S, Pesci A, Dupont LJ, Fardon TC, Wilson R, Loebinger MR, Skrbic D, Obradovic D, De Soyza A, Ward C, Laffey JG, Rutherford RM, Chalmers JD. Comorbidities and the risk of mortality in patients with bronchiectasis: an international multicentre cohort study. Lancet Respir Med. 2016 Dec;4(12):969-979. doi: 10.1016/S2213-2600(16)30320-4. Epub 2016 Nov 16.

  PMID: 27864036 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

The remaining samples after the completion of this study are deposited in the Human Genome Database of Chang Gung Memorial Medical Center \_ Linkou \_\_ Chang Gung Memorial Hospital for the follow-up study (including gene research) approved by the Human Ethics Committee of the Hospital

MeSH Terms

Conditions

Osteoporosis; Bone Diseases, Metabolic

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Chun-Hua Wang

  Chang Chung Memorial Hospital

  STUDY DIRECTOR

Central Study Contacts

Hung-Yu Huang, MD

CONTACT

033281200; b9202071@cgmh.org.tw

Chun-Hua Wang, MD

CONTACT

033281200; wchunhua@ms7.hinet.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: March 7, 2018
• First Posted: March 15, 2018
• Study Start: December 21, 2017
• Primary Completion: December 31, 2018
• Study Completion: June 30, 2019
• Last Updated: March 15, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)