Early-onset Obesity and Cognitive Impairment in Children With Pseudohypoparathyroidism

Completed

• Conditions: Pseudohypoparathyroidism; Albright Hereditary Osteodystrophy

• Registration Number: NCT02411461
• Lead Sponsor: Vanderbilt University Medical Center

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.

Study Timeline

• Study Start: 2014-12-01
• Study First Submitted: 2015-02-25
• Study First Submitted QC: 2015-04-07
• Study First Posted: 2015-04-08
• Primary Completion: 2017-01
• Study Completion: 2017-01
• Results First Submitted: 2018-02-28
• Results First Submitted QC: 2018-05-08
• Results First Posted: 2018-06-08
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-30
• Last Update Posted: 2019-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Intelligence Quotient	one day	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.

Trial Locations

Locations (1)

Vanderbilt University; 🇺🇸 Nashville, Tennessee, United States