Cushing's DiseaseNCT00881283
Long-term Cardiovascular Risk in Cured Cushing's Patients
An observational study of Cushing's Disease, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The purpose of this study is to determine whether subjects who have been affected by Cushing's disease in the past maintain some different characteristics compared with subjects who have never been diagnosed with the disease. Read more about this study
- Who is it for?
- Ages 35 to 55 years, women only
- Conditions the study is for
- Cushing's Disease
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Sep 2008to 30 Mar 2010
- 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 35 to 55 years
- Women only
- No healthy volunteers
- Adult
Study population: Cured Cushing's disease
Who may be able to join
- patients who have been cured of Cushing's disease at least 5 years ago.
Who cannot join
- patients who have been cured of Cushing's disease more than 15 years ago.
Trial locations and contacts
1 site in 1 country.
United States1 site
Neuroendocrine Clinical Center
Boston, Massachusetts, 02114
About this study
Official title: Role of Adipokines in Long-term Cardiovascular Risk in Cured Cushing's Patients
The purpose of this study is to determine whether subjects who have been affected by Cushing's disease in the past maintain some different characteristics compared with subjects who have never been diagnosed with the disease.
- Conditions
- Cushing's Disease
- Keywords
- Cushing's disease
- Medical subject headings
- Pituitary ACTH Hypersecretion
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 |
|---|---|---|
| cured Cushing's disease | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
adipokine measurements
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2009 (estimated)
- Study start8 Sep 2008
- Primary completion30 Mar 2010
- Study completion30 Mar 2010
Why it stopped: Decision made to close study early.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cushing's DiseaseStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karen Klahr Miller, MD, Massachusetts General Hospital
- Investigators
- Anne Klibanski, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00881283
- Sponsor's protocol ID
- 2008-p-001379
- Status last verified
- Aug 2020
- First submitted
- 13 Apr 2009
- Last updated
- 2 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Adipokines in Long-term Cardiovascular Risk in Cured Cushing's Patients
- ClinicalTrials.gov ID
- NCT00881283
- Acronym / sponsor ID
- 2008-p-001379
- Conditions
- Cushing's Disease
- Keywords
- Cushing's disease
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Decision made to close study early.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 8 Sep 2008 (actual)
- Primary completion
- 30 Mar 2010 (actual)
- Study completion
- 30 Mar 2010 (actual)
- First posted
- 15 Apr 2009 (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 determine whether subjects who have been affected by Cushing's disease in the past maintain some different characteristics compared with subjects who have never been diagnosed with the disease.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cured Cushing's disease | – | – |
Who may qualify
- Ages
- 35 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Cured Cushing's disease
Key inclusion criteria (1 listed)
- patients who have been cured of Cushing's disease at least 5 years ago.
Key exclusion criteria (1 listed)
- patients who have been cured of Cushing's disease more than 15 years ago.
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
adipokine measurements
Time frame: baseline
Results and safety
The study was stopped early (reason given: Decision made to close study early.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2020.
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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.
Anne Klibanski, MD principal investigator
Massachusetts General Hospital
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 Cushing's Disease, run by Massachusetts General Hospital 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 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 2 Sep 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 was stopped early (reason given: Decision made to close study early.). 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?
adipokine measurements (time frame: baseline). 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 2 Sep 2020.