Pseudohypoparathyroidism Type 1ANCT01398774
Energy Expenditure and Body Composition in Pseudohypoparathyroidism 1a
An observational study of Pseudohypoparathyroidism Type 1A and Albright Hereditary Osteodystrophy, run by Children's Hospital of Philadelphia at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 5 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Pseudohypoparathyroidism Type 1A, Albright Hereditary Osteodystrophy
- How many people
- 519 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2011to 20 Nov 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 45 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Subjects with Pseudohypoparathyroidism 1a
Who may be able to join
- Diagnosis of pseudohypoparathyroidism 1a
- Any body weight
Who cannot join
- Absence of above diagnosis
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
About this study
Official title: 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.
Read the 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.
- Keywords
- Pseudohypoparathyroidism, Albright Hereditary Osteodystrophy
- Medical subject headings
- Pseudohypoparathyroidism
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 minutes
Secondary outcomes (1)
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2011 (estimated)
- Study startJun 2011
- Primary completionSep 2015
- Study completion20 Nov 2017
Why it stopped: study expired
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pseudohypoparathyroidism Type 1AStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 519 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael A Levine, M.D., Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01398774
- Sponsor's protocol ID
- 11-007972
- Status last verified
- Aug 2018
- First submitted
- 19 Jul 2011
- Last updated
- 22 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 26709970
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Altered Resting Energy Expenditure as a Cause of Obesity in Pseudohypoparathyroidism 1a: A Pilot Study
- ClinicalTrials.gov ID
- NCT01398774
- Acronym / sponsor ID
- 11-007972
- Keywords
- Pseudohypoparathyroidism, Albright Hereditary Osteodystrophy
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: study expired
- Enrolment
- 519 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Sep 2015 (actual)
- Study completion
- 20 Nov 2017 (actual)
- First posted
- 21 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 5 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Subjects with Pseudohypoparathyroidism 1a
Key inclusion criteria (2 listed)
- Diagnosis of pseudohypoparathyroidism 1a
- Any body weight
Key exclusion criteria (1 listed)
- Absence of above diagnosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Characterize body composition in patients with PHP1a.
Time frame: 12 months
Results and safety
The study was stopped early (reason given: study expired). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2018.
- Derived from this study: PubMed 26709970Roizen 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.
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Setmelanotide to Treat Obesity in a Patient With Pseudohypoparathyroidism Type 1a (PHP1a)
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Albright Hereditary Osteodystrophy: Natural History, Growth, and Cognitive/Behavioral Assessments
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael A Levine, M.D. principal investigator
Children's Hospital of Philadelphia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pseudohypoparathyroidism Type 1A and Albright Hereditary Osteodystrophy, run by Children's Hospital of Philadelphia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: study expired). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resting Energy Expenditure (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01398774, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2018.