Assessment of Fat Free Mass Index and Its Impact on Health in Children With Cystic Fibrosis

NCT01401439 | Completed

• 1 other identifier: 131677
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to find out whether measurement of body composition has a prognostic value on clinical and overall outcome in pediatric patients with cystic fibrosis.

Conditions

Cystic Fibrosis

Keywords

cystic fibrosis; body mass index; fat free mass; Children with cystic fibrosis

Outcome Measures

Primary Outcomes (1)

• body composition (bone mineral density)

  Compare Dual Energy X-Ray Absorptiometry (DEXA) analysis to GAIA device

  change from baseline to 18 months

Eligibility Criteria

• Age: 7 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Children with cystic fibrosis 7-17 years followed at Arkansas Children's hospital Cystic Fibrosis Care Center

You may qualify if:

• Subjects who already have a diagnosis of CF based on universal diagnostic criteria
• Age 7 to 17 years at the time of enrollment
• Under routine medical control at the CF center of Arkansas Children's Hospital(ACH)
• Clinically stable in CF symptoms as determined by investigators

You may not qualify if:

• Unstable current diagnosis of metabolic diseases including liver (cirrhosis) or renal disease
• Failure to give informed consent
• Individuals with pacemakers
• Pregnancy in females of childbearing age. A pregnancy test will be performed on females who are post-menarche before performing a DEXA scan

Sponsors & Collaborators

• University of Arkansas: lead
• Arkansas Children's Hospital Research Institute: collaborator

Study Sites (1)

Arkansas Children's Hospital

Little Rock, Arkansas, 72202, United States

Location

Related Publications (10)

• Zemel BS, Jawad AF, FitzSimmons S, Stallings VA. Longitudinal relationship among growth, nutritional status, and pulmonary function in children with cystic fibrosis: analysis of the Cystic Fibrosis Foundation National CF Patient Registry. J Pediatr. 2000 Sep;137(3):374-80. doi: 10.1067/mpd.2000.107891.

  PMID: 10969263 BACKGROUND

• Ionescu AA, Evans WD, Pettit RJ, Nixon LS, Stone MD, Shale DJ. Hidden depletion of fat-free mass and bone mineral density in adults with cystic fibrosis. Chest. 2003 Dec;124(6):2220-8. doi: 10.1378/chest.124.6.2220.

  PMID: 14665504 BACKGROUND

• Bolton CE, Ionescu AA, Evans WD, Pettit RJ, Shale DJ. Altered tissue distribution in adults with cystic fibrosis. Thorax. 2003 Oct;58(10):885-9. doi: 10.1136/thorax.58.10.885.

  PMID: 14514945 BACKGROUND

• Wolfe RR. Regulation of muscle protein by amino acids. J Nutr. 2002 Oct;132(10):3219S-24S. doi: 10.1093/jn/131.10.3219S.

  PMID: 12368421 BACKGROUND

• Reeds PJ, Fjeld CR, Jahoor F. Do the differences between the amino acid compositions of acute-phase and muscle proteins have a bearing on nitrogen loss in traumatic states? J Nutr. 1994 Jun;124(6):906-10. doi: 10.1093/jn/124.6.906. No abstract available.

  PMID: 7515956 BACKGROUND

• Ionescu AA, Nixon LS, Evans WD, Stone MD, Lewis-Jenkins V, Chatham K, Shale DJ. Bone density, body composition, and inflammatory status in cystic fibrosis. Am J Respir Crit Care Med. 2000 Sep;162(3 Pt 1):789-94. doi: 10.1164/ajrccm.162.3.9910118.

  PMID: 10988084 BACKGROUND

• Moriconi N, Kraenzlin M, Muller B, Keller U, Nusbaumer CP, Stohr S, Tamm M, Puder JJ. Body composition and adiponectin serum concentrations in adult patients with cystic fibrosis. J Clin Endocrinol Metab. 2006 Apr;91(4):1586-90. doi: 10.1210/jc.2005-2135. Epub 2006 Feb 7.

  PMID: 16464949 BACKGROUND

• Engelen MP, Schols AM, Does JD, Wouters EF. Skeletal muscle weakness is associated with wasting of extremity fat-free mass but not with airflow obstruction in patients with chronic obstructive pulmonary disease. Am J Clin Nutr. 2000 Mar;71(3):733-8. doi: 10.1093/ajcn/71.3.733.

  PMID: 10702166 BACKGROUND

• Black LF, Hyatt RE. Maximal respiratory pressures: normal values and relationship to age and sex. Am Rev Respir Dis. 1969 May;99(5):696-702. doi: 10.1164/arrd.1969.99.5.696. No abstract available.

  PMID: 5772056 BACKGROUND

• Quittner AL, Sweeny S, Watrous M, Munzenberger P, Bearss K, Gibson Nitza A, Fisher LA, Henry B. Translation and linguistic validation of a disease-specific quality of life measure for cystic fibrosis. J Pediatr Psychol. 2000 Sep;25(6):403-14. doi: 10.1093/jpepsy/25.6.403.

  PMID: 10980045 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood sample

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Study Officials

• Ariel Berlinski, MD

  University of Arkansas for Medical Sciences/Arkansas Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2011
• First Posted: July 25, 2011
• Study Start: June 1, 2012
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: August 9, 2016

Record last verified: 2016-08

Locations

US (1)