Energy Expenditure and Body Composition in Pseudohypoparathyroidism 1a

Albright Hereditary Osteodystrophy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01398774
• Other study ID #: 11-007972
• Status: Terminated
• Start date: June 2011
• Est. completion date: November 20, 2017

Study information

• Verified date: August 2018
• Source: Children's Hospital of Philadelphia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 519
• Est. completion date: November 20, 2017
• Est. primary completion date: September 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 45 Years

Eligibility

Inclusion Criteria:

• Diagnosis of pseudohypoparathyroidism 1a

• Any body weight

Exclusion Criteria:

• Absence of above diagnosis

Related Conditions & MeSH terms

• Albright Hereditary Osteodystrophy
• Pseudohypoparathyroidism
• Pseudohypoparathyroidism Type 1A

Locations

Country	Name	City	State
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital of Philadelphia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Characterize body composition in patients with PHP1a.	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