Growth Hormone DeficiencyNCT00004365
Study of Pituitary Size and Function in Familial Dwarfism of Sindh
An observational study of Growth Hormone Deficiency, run by National Center for Research Resources (NCRR).
Trial summary
OBJECTIVES: I. Assess pituitary size and anatomic configuration by magnetic resonance imaging (MRI) in 4 affected dwarfs in the province of Sindh, Pakistan. II. Evaluate ultradian growth hormone (GH) secretory patterns in 4 affected dwarfs. Read more about this study
- Who is it for?
- Ages 10 to 60 years
- Conditions the study is for
- Growth Hormone Deficiency
- How many people
- 4 participants
- Where
- No sites listed yet
- Study dates
- Sep 1995to Feb 2000
- 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 10 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
- Familial Dwarfism of Sindh
- Severe short stature but proportionate without dysmorphic features
- Normal body size and weight at birth
- Bone age is severely delayed
- Puberty is somewhat delayed (age 15-16)
- Fertility present in at least 3 dwarfs
About this study
OBJECTIVES: I. Assess pituitary size and anatomic configuration by magnetic resonance imaging (MRI) in 4 affected dwarfs in the province of Sindh, Pakistan.
II. Evaluate ultradian growth hormone (GH) secretory patterns in 4 affected dwarfs.
Read the detailed description
PROTOCOL OUTLINE: Pituitary size and anatomy and growth hormone response are evaluated.
All patients undergo MRI of the pituitary fossa on day 1. On day 2, homozygous patients receive a slow infusion of normal saline with blood sampling every 10 minutes.
- Conditions
- Growth Hormone Deficiency
- Keywords
- endocrine disorders, growth hormone deficiency, rare disease
- Medical subject headings
- Dwarfism, Pituitary, Endocrine System Diseases, Rare Diseases
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 1999 (estimated)
- Study startSep 1995
- Study completionFeb 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Growth Hormone DeficiencyStudies of the same condition, open and under way.
- 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
- Enrolment
- 4 participants
Sponsor and investigators
- Lead sponsor
- National Center for Research Resources (NCRR)
- Sponsor type
- US National Institutes of Health
- Collaborators
- Northwestern University
- Investigators
- Gerhard Baumann, Study chair, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00004365
- Sponsor's protocol ID
- 199/11940
- Other IDs
- NU-571
- Status last verified
- Dec 2003
- First submitted
- 18 Oct 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
Publications
Baumann G, Maheshwari H. The Dwarfs of Sindh: severe growth hormone (GH) deficiency caused by a mutation in the GH-releasing hormone receptor gene. Acta Paediatr Suppl. 1997 Nov;423:33-8. doi: 10.1111/j.1651-2227.1997.tb18366.x.
PubMed 9401536Maheshwari HG, Silverman BL, Dupuis J, Baumann G. Phenotype and genetic analysis of a syndrome caused by an inactivating mutation in the growth hormone-releasing hormone receptor: Dwarfism of Sindh. J Clin Endocrinol Metab. 1998 Nov;83(11):4065-74. doi: 10.1210/jcem.83.11.5226.
PubMed 9814493
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Pituitary Size and Function in Familial Dwarfism of Sindh
- ClinicalTrials.gov ID
- NCT00004365
- Acronym / sponsor ID
- 199/11940
- Conditions
- Growth Hormone Deficiency
- Keywords
- endocrine disorders, growth hormone deficiency, rare disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4 participants
- Lead sponsor
- National Center for Research Resources (NCRR)US National Institutes of Health
- Collaborators
- Northwestern University
- Study start
- Sep 1995
- Study completion
- Feb 2000
- First posted
- 19 Oct 1999 (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.
OBJECTIVES: I. Assess pituitary size and anatomic configuration by magnetic resonance imaging (MRI) in 4 affected dwarfs in the province of Sindh, Pakistan.
II. Evaluate ultradian growth hormone (GH) secretory patterns in 4 affected dwarfs.
Detailed description
PROTOCOL OUTLINE: Pituitary size and anatomy and growth hormone response are evaluated.
All patients undergo MRI of the pituitary fossa on day 1. On day 2, homozygous patients receive a slow infusion of normal saline with blood sampling every 10 minutes.
Study design
Who may qualify
- Ages
- 10 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
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
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
- Background: PubMed 9401536Baumann G, Maheshwari H. The Dwarfs of Sindh: severe growth hormone (GH) deficiency caused by a mutation in the GH-releasing hormone receptor gene. Acta Paediatr Suppl. 1997 Nov;423:33-8. doi: 10.1111/j.1651-2227.1997.tb18366.x.
- Background: PubMed 9814493Maheshwari HG, Silverman BL, Dupuis J, Baumann G. Phenotype and genetic analysis of a syndrome caused by an inactivating mutation in the growth hormone-releasing hormone receptor: Dwarfism of Sindh. J Clin Endocrinol Metab. 1998 Nov;83(11):4065-74. doi: 10.1210/jcem.83.11.5226.
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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.
Gerhard Baumann study chair
Northwestern University
Questions about this trial
What is this clinical trial studying?
An observational study of Growth Hormone Deficiency, run by National Center for Research Resources (NCRR).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00004365, which also lists 2 linked publications.
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 24 Jun 2005.