Clinical trial NCT02411461: Early-onset Obesity and Cognitive Impairment in Children With Pseudohypoparathyroidism
Official title: Early-onset Obesity and Cognitive Impairment in Children With Pseudohypoparathyroidism
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pseudohypoparathyroidism
Albright Hereditary Osteodystrophy
Keywords: Pediatric obesity
pseudohypoparathyroidism
Albright Hereditary Osteodystrophy
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2015-04-08
Enrollment: 39
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children with pseudohypoparathyroidism type 1a (PHP1a), their healthy siblings and matched obese controls

Brief summary: Pseudohypoparathyroidism type 1a (PHP1a) is a rare disease that causes childhood obesity and learning difficulties. This study will investigate eating behaviors and perform cognitive testing on children with PHP1a. The investigators will compare their results to those of healthy siblings and other obese children.

Detailed description: Pseudohypoparathyroidism type 1a (PHP1a) is a genetic disorder that causes early-onset, syndromic obesity and cognitive impairment. This study aims to evaluate eating behaviors, cognition and executive function in children with PHP1a, compared with healthy siblings and matched obese controls.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of PHP1a, sibling of a patient with PHP1a or matched obese control

Exclusion Criteria (PHP1a):

* Treatment with appetite-altering drug or initiation of a new weight loss program in the past 3 months
* Type 2 diabetes

Exclusion Criteria (Controls):

* Obesity due to a genetic syndrome, growth hormone deficiency, untreated hypothyroidism, Cushing syndrome or exogenous glucocorticoid administration
* Weight loss greater than 10% over the previous 6 months
* Autism or other significant learning disorder
* Type 2 diabetes
* Other significant medical condition

Primary outcomes:
measure: Intelligence Quotient
timeFrame: one day
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
Study officials:
affiliation: Vanderbilt University
name: Ashley Shoemaker, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shoemaker AH, Lomenick JP, Saville BR, Wang W, Buchowski MS, Cone RD. Energy expenditure in obese children with pseudohypoparathyroidism type 1a. Int J Obes (Lond). 2013 Aug;37(8):1147-53. doi: 10.1038/ijo.2012.200. Epub 2012 Dec 11.
citation: Wang L, Shoemaker AH. Eating behaviors in obese children with pseudohypoparathyroidism type 1a: a cross-sectional study. Int J Pediatr Endocrinol. 2014;2014(1):21. doi: 10.1186/1687-9856-2014-21. Epub 2014 Oct 15.
citation: Landreth H, Malow BA, Shoemaker AH. Increased Prevalence of Sleep Apnea in Children with Pseudohypoparathyroidism Type 1a. Horm Res Paediatr. 2015;84(1):1-5. doi: 10.1159/000381452. Epub 2015 Apr 23.
citation: Perez KM, Lee EB, Kahanda S, Duis J, Reyes M, Juppner H, Shoemaker AH. Cognitive and behavioral phenotype of children with pseudohypoparathyroidism type 1A. Am J Med Genet A. 2018 Feb;176(2):283-289. doi: 10.1002/ajmg.a.38534. Epub 2017 Nov 28.