Energy Expenditure and Body Composition in Pseudohypoparathyroidism 1a

August 20, 2018 updated by: Children's Hospital of Philadelphia

Altered Resting Energy Expenditure as a Cause of Obesity in Pseudohypoparathyroidism 1a: A Pilot Study

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.

Study Overview

Status

Terminated

Conditions

Detailed Description

Pseudohypoparathyroidism 1a (PHP1a) is a disorder that is associated with many endocrine problems. People with PHP1a are at risk for the development of obesity. The objective of the study will help determine if obesity is related to abnormalities energy expenditure, meaning that people with PHP1a may not burn as many calories while at rest as those without the disorder.

In order to further evaluate obesity in PHP1a, investigators are planning to measure resting energy expenditure (REE), which is the amount of calories burned while completely at rest. Investigators will also evaluate body composition by looking at measures of growth and development and determining the amount of body fat using dual energy x-ray absorptiometry (DXA) as well as blood and urine biologic markers of obesity. The investigators plan to evaluate people with PHP1a at all weights.

Study Type

Observational

Enrollment (Actual)

519

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Children's Hospital of Philadelphia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 45 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects with Pseudohypoparathyroidism 1a

Description

Inclusion Criteria:

  • Diagnosis of pseudohypoparathyroidism 1a
  • Any body weight

Exclusion Criteria:

  • Absence of above diagnosis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Resting Energy Expenditure
Time Frame: 30 minutes
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Characterize body composition in patients with PHP1a.
Time Frame: 12 months
Body composition outcomes will be characterized by whole body lean mass and fat mass sex- and race-specific z-scores relative to height.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Hospital of Philadelphia

Investigators

  • Principal Investigator: Michael A Levine, M.D., Children's Hospital of Philadelphia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

November 20, 2017

Study Registration Dates

First Submitted

July 19, 2011

First Submitted That Met QC Criteria

July 20, 2011

First Posted (Estimate)

July 21, 2011

Study Record Updates

Last Update Posted (Actual)

August 22, 2018

Last Update Submitted That Met QC Criteria

August 20, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11-007972

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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