ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 5 of 9 for:    "Albrights hereditary osteodystrophy"

Early-onset Obesity and Cognitive Impairment in Children With Pseudohypoparathyroidism

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02411461
Recruitment Status : Completed
First Posted : April 8, 2015
Results First Posted : June 8, 2018
Last Update Posted : June 8, 2018
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Ashley Shoemaker, 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.

Condition or disease
Pseudohypoparathyroidism Albright Hereditary Osteodystrophy

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 Type : Observational
Actual Enrollment : 39 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Early-onset Obesity and Cognitive Impairment in Children With Pseudohypoparathyroidism
Study Start Date : December 2014
Actual Primary Completion Date : January 2017
Actual Study Completion Date : January 2017


Group/Cohort
Pseudohypoparathyroidism type 1a
Study group
Healthy siblings
Control group
Obese patients
Control group



Primary Outcome Measures :
  1. Intelligence Quotient [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Children with pseudohypoparathyroidism type 1a (PHP1a), their healthy siblings and matched obese controls
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02411461


Locations
United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University Medical Center
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Ashley Shoemaker, MD Vanderbilt University

Additional Information:
Publications:
Responsible Party: Ashley Shoemaker, Assistant Professor of Pediatrics, Pediatric Endocrinology and Diabetes, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT02411461     History of Changes
Other Study ID Numbers: VR7195
1K23DK101689-01A1 ( U.S. NIH Grant/Contract )
First Posted: April 8, 2015    Key Record Dates
Results First Posted: June 8, 2018
Last Update Posted: June 8, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Ashley Shoemaker, Vanderbilt University Medical Center:
Pediatric obesity
pseudohypoparathyroidism
Albright Hereditary Osteodystrophy

Additional relevant MeSH terms:
Obesity
Cognitive Dysfunction
Pseudohypoparathyroidism
Pseudopseudohypoparathyroidism
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metal Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases
Calcium Metabolism Disorders