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Energy Expenditure and Body Composition in Pseudohypoparathyroidism 1a

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier:
NCT01398774
First received: July 19, 2011
Last updated: October 28, 2013
Last verified: October 2013
  Purpose

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.


Condition
Pseudohypoparathyroidism Type 1A
Albright Hereditary Osteodystrophy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Altered Resting Energy Expenditure as a Cause of Obesity in Pseudohypoparathyroidism 1a: A Pilot Study

Resource links provided by NLM:


Further study details as provided by Children's Hospital of Philadelphia:

Primary Outcome Measures:
  • Resting Energy Expenditure [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Characterize body composition in patients with PHP1a. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Body composition outcomes will be characterized by whole body lean mass and fat mass sex- and race-specific z-scores relative to height.


Estimated Enrollment: 20
Study Start Date: June 2011
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   5 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Subjects with Pseudohypoparathyroidism 1a

Criteria

Inclusion Criteria:

  • Diagnosis of pseudohypoparathyroidism 1a
  • Any body weight

Exclusion Criteria:

  • Absence of above diagnosis
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01398774

Locations
United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Children's Hospital of Philadelphia
Investigators
Principal Investigator: Michael A Levine, M.D. Children's Hospital of Philadelphia
  More Information

No publications provided

Responsible Party: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT01398774     History of Changes
Other Study ID Numbers: 11-007972
Study First Received: July 19, 2011
Last Updated: October 28, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospital of Philadelphia:
Pseudohypoparathyroidism
Albright Hereditary Osteodystrophy

Additional relevant MeSH terms:
Pseudohypoparathyroidism
Pseudopseudohypoparathyroidism
Bone Diseases
Bone Diseases, Metabolic
Calcium Metabolism Disorders
Genetic Diseases, Inborn
Metabolic Diseases
Metabolism, Inborn Errors
Metal Metabolism, Inborn Errors
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on November 25, 2014