NCT01398774

Brief Summary

The investigators would like to learn more about the metabolic consequences of pseudohypoparathyroidism type 1a in children, adolescents and adults with this condition. People with pseudohypoparathyroidism 1a are at risk for development of obesity. To better understand the cause of overweight or obesity, investigators are measuring body composition and resting energy expenditure (REE), which is the amount of calories burned while completely at rest. The investigators also want to determine the amount of body fat.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
519

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 19, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 21, 2011

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2017

Completed
Last Updated

August 22, 2018

Status Verified

August 1, 2018

Enrollment Period

4.3 years

First QC Date

July 19, 2011

Last Update Submit

August 20, 2018

Conditions

Keywords

PseudohypoparathyroidismAlbright Hereditary Osteodystrophy

Outcome Measures

Primary Outcomes (1)

  • Resting Energy Expenditure

    The subject will rest for 30 minutes in the lab prior to the start of the test. A 60-minute resting energy expenditure (REE) test will be performed between 7:00 and 10:00 A.M. with the subject resting quietly under a clear, plastic hood watching a videotape.

    30 minutes

Secondary Outcomes (1)

  • Characterize body composition in patients with PHP1a.

    12 months

Eligibility Criteria

Age5 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Subjects with Pseudohypoparathyroidism 1a

You may qualify if:

  • Diagnosis of pseudohypoparathyroidism 1a
  • Any body weight

You may not qualify if:

  • Absence of above diagnosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

  • Roizen JD, Danzig J, Groleau V, McCormack S, Casella A, Harrington J, Sochett E, Tershakovec A, Zemel BS, Stallings VA, Levine MA. Resting Energy Expenditure Is Decreased in Pseudohypoparathyroidism Type 1A. J Clin Endocrinol Metab. 2016 Mar;101(3):880-8. doi: 10.1210/jc.2015-3895. Epub 2015 Dec 28.

MeSH Terms

Conditions

Pseudohypoparathyroidism

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 Disorders

Study Officials

  • Michael A Levine, M.D.

    Children's Hospital of Philadelphia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 19, 2011

First Posted

July 21, 2011

Study Start

June 1, 2011

Primary Completion

September 1, 2015

Study Completion

November 20, 2017

Last Updated

August 22, 2018

Record last verified: 2018-08

Locations