NCT02411461

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 25, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 8, 2015

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

June 8, 2018

Completed
Last Updated

November 13, 2019

Status Verified

October 1, 2019

Enrollment Period

2.1 years

First QC Date

February 25, 2015

Results QC Date

February 28, 2018

Last Update Submit

October 30, 2019

Conditions

PseudohypoparathyroidismAlbright Hereditary Osteodystrophy

Keywords

Pediatric obesitypseudohypoparathyroidismAlbright Hereditary Osteodystrophy

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (3)

Pseudohypoparathyroidism type 1a

Study group

Healthy siblings

Control group

Obese patients

Control group

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Children with pseudohypoparathyroidism type 1a (PHP1a), their healthy siblings and matched obese controls

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt University

Nashville, Tennessee, 37232, United States

Location

Related Publications (4)

  • 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.

    PMID: 23229731BACKGROUND

  • 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.

    PMID: 25337124BACKGROUND

  • 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.

    PMID: 25925491BACKGROUND

  • 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.

    PMID: 29193623BACKGROUND

Related Links

MeSH Terms

Conditions

PseudohypoparathyroidismPediatric Obesity

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetal Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesMetabolic DiseasesNutritional and Metabolic DiseasesCalcium Metabolism DisordersObesityOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Ashley Shoemaker, Principal Investigator
Organization
Vanderbilt University Medical Center
ashley.h.shoemaker@vanderbilt.edu
6153438116

Study Officials

  • Ashley Shoemaker, MD

    Vanderbilt University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Pediatrics, Pediatric Endocrinology and Diabetes

Study Record Dates

First Submitted

February 25, 2015

First Posted

April 8, 2015

Study Start

December 1, 2014

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

November 13, 2019

Results First Posted

June 8, 2018

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)