Early-onset Obesity and Cognitive Impairment in Children With Pseudohypoparathyroidism

Pseudohypoparathyroidism Clinical Trial

Official title:

Early-onset Obesity and Cognitive Impairment in Children With Pseudohypoparathyroidism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02411461
• Other study ID #: VR7195
• Secondary ID: 1K23DK101689-01A
• Status: Completed
• Start date: December 1, 2014
• Est. completion date: January 2017

Study information

• Verified date: October 2019
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Albright Hereditary Osteodystrophy
• Cognitive Dysfunction
• Obesity
• Pseudohypoparathyroidism

Locations

Country	Name	City	State
United States	Vanderbilt University	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View Citation

Perez KM, Lee EB, Kahanda S, Duis J, Reyes M, Jüppner 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intelligence Quotient	Intelligence quotient as measured by Kaufman Brief Intelligence Test, 2nd Edition. This scale yields standard scores where the mean is 100 and one standard deviation is 15. Higher scores indicate better function.	one day

External Links

•   Vanderbilt PHP Research Group Website