AcromegalyNCT00001981
The Treatment and Natural History of Acromegaly
An observational study of Acromegaly and Pituitary Neoplasm, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
Trial summary
The purpose of this study is to investigate the treatment and natural history of acromegaly. We have a longstanding interest in acromegaly treatment, and a cohort that has been followed for 30 years, or more in some cases. We will continue to follow patients and recruit new patients for treatment and follow-up. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acromegaly, Pituitary Neoplasm
- How many people
- 117 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Oct 1991to 20 Nov 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study involved patients who were referred to us and had acromegaly.@@@@@@
Who may be able to join
- Patients will be enrolled who are 18 years of age or over who are referred for care.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Acromegaly Treatment and Natural History
The purpose of this study is to investigate the treatment and natural history of acromegaly. We have a longstanding interest in acromegaly treatment, and a cohort that has been followed for 30 years, or more in some cases. We will continue to follow patients and recruit new patients for treatment and follow-up. Blood and pituitary tumor tissue (when available through clinical care) will be saved for future analyses related to acromegaly.
Read the detailed description
The purpose of this study is to investigate the treatment and natural history of acromegaly. We have a longstanding interest in acromegaly treatment, and a cohort that has been followed for 30 years, or more in some cases. We will continue to follow patients and recruit new patients for treatment and follow-up.
- Conditions
- Acromegaly, Pituitary Neoplasm
- Keywords
- Acromegaly
- Medical subject headings
- Acromegaly, Pituitary Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with acromegaly | Patients with acromegaly |
What is being measured
The primary outcome is the main question the study is designed to answer.
resolution of IGF-1 Growth Hormone abnormality
resolution of IGF-1 abnormality
Measured: every 6 months & at end of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2000 (estimated)
- Study start2 Oct 1991
- Primary completion20 Nov 2020
- Study completion20 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AcromegalyStudies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The 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
- Prospective
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Phillip Gorden, M.D., Principal investigator, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001981
- Sponsor's protocol ID
- 850082
- Other IDs
- 85-DK-0082
- Status last verified
- Nov 2020
- First submitted
- 21 Jan 2000
- Last updated
- 27 Nov 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acromegaly Treatment and Natural History
- ClinicalTrials.gov ID
- NCT00001981
- Acronym / sponsor ID
- 850082
- Conditions
- Acromegaly, Pituitary Neoplasm
- Keywords
- Acromegaly
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Study start
- 2 Oct 1991 (actual)
- Primary completion
- 20 Nov 2020 (actual)
- Study completion
- 20 Nov 2020 (actual)
- First posted
- 24 Jan 2000 (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 purpose of this study is to investigate the treatment and natural history of acromegaly. We have a longstanding interest in acromegaly treatment, and a cohort that has been followed for 30 years, or more in some cases. We will continue to follow patients and recruit new patients for treatment and follow-up. Blood and pituitary tumor tissue (when available through clinical care) will be saved for future analyses related to acromegaly.
Detailed description
The purpose of this study is to investigate the treatment and natural history of acromegaly. We have a longstanding interest in acromegaly treatment, and a cohort that has been followed for 30 years, or more in some cases. We will continue to follow patients and recruit new patients for treatment and follow-up.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with acromegaly | – | –Patients with acromegaly |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study involved patients who were referred to us and had acromegaly.@@@@@@
Key inclusion criteria (1 listed)
- Patients will be enrolled who are 18 years of age or over who are referred for care.
Key exclusion criteria (0 listed)
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
resolution of IGF-1 Growth Hormone abnormality
Time frame: every 6 months & at end of study
resolution of IGF-1 abnormality
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 27 Nov 2020.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
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A Study to Assess the Efficacy and Safety of Debio 4126 in Participants With Acromegaly Previously Treated With Somatostatin Analogs
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RecruitingObservational study
An Investigation of Pituitary Tumors and Related Hypothalmic Disorders
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Recruiting
Managing Pasireotide-associated Hyperglycaemia in Acromegaly With Ketogenic Diet
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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.
Phillip Gorden, M.D. principal investigator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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 Acromegaly and Pituitary Neoplasm, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) 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 1 inclusion and 0 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: finished, as of the sponsor's last update on 27 Nov 2020. 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 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.
What does the primary outcome measure?
resolution of IGF-1 Growth Hormone abnormality (time frame: every 6 months & at end of study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Nov 2020.