AcromegalyNCT01819883
Ectopic Lipid Deposition and Insulin Resistance in After Treatment of Acromegaly
An observational study of Acromegaly, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
This study investigates fat distribution in people with acromegaly. The investigator is also investigating the change of fat distribution before and after treatment of acromegaly. The investigator will compare the results of people with acromegaly to the results of healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Acromegaly
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to 30 Mar 2016
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Thirty-two study subjects will be studied: 1) patients with active acromegaly, and 2) healthy controls. Study subjects with acromegaly will be prescribed treatment for acromegaly by their healthcare providers, and this study will not interfere in anyway with clinical care and will not provide surgery, medications or other forms of clinical care.
Who may be able to join
- Ages 18 - 75 yr (both groups)
- Study subjects with active acromegaly
- Healthy controls
Who cannot join
- Serum creatinine or alanine aminotransferase (ALT) > 2 times the upper limit of normal, metastatic cancer.
- Controls will be receiving no medications and have no chronic diseases, including cancer, hypertension or diabetes mellitus.
- Contraindications to MRI imaging (both groups) like those with certain metal implants, surgical clips or pacemakers.
- Pregnant women
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
This study investigates fat distribution in people with acromegaly. The investigator is also investigating the change of fat distribution before and after treatment of acromegaly. The investigator will compare the results of people with acromegaly to the results of healthy volunteers.
- Conditions
- Acromegaly
- Medical subject headings
- Acromegaly
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 |
|---|---|---|
| Active Acromegaly | All study subjects with acromegaly will be studied twice - once during the active stage of their disease (pre-treatment) and a second time: 3 months after treatment of acromegaly. Controls will be studied at one time point. | |
| Healthy controls | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Liver Fat
Change in intrahepatic fat after biochemical control of acromegaly
Measured: Baseline and 3-month follow-up visit
Change in Thigh Muscle Cross-sectional Area
Change in thigh muscle cross-sectional area after biochemical control of acromegaly
Measured: Baseline and 3-month follow-up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2013 (estimated)
- Study startApr 2013
- Primary completion30 Mar 2016
- Study completion30 Mar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AcromegalyStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ipsen
- Responsible party
- Principal investigator, Karen Klahr Miller, MD, Massachusetts General Hospital
- Investigators
- Karen Miller, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01819883
- Sponsor's protocol ID
- 2012P002517
- Status last verified
- Jun 2018
- First submitted
- 22 Mar 2013
- Last updated
- 20 Jun 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ectopic Lipid Deposition and Insulin Resistance in After Treatment of Acromegaly
- ClinicalTrials.gov ID
- NCT01819883
- Acronym / sponsor ID
- 2012P002517
- Conditions
- Acromegaly
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Ipsen
- Study start
- Apr 2013 (actual)
- Primary completion
- 30 Mar 2016 (actual)
- Study completion
- 30 Mar 2016 (actual)
- First posted
- 28 Mar 2013 (estimated)
- Results
- Posted 20 Jun 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study investigates fat distribution in people with acromegaly. The investigator is also investigating the change of fat distribution before and after treatment of acromegaly. The investigator will compare the results of people with acromegaly to the results of healthy volunteers.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Acromegaly | – | –All study subjects with acromegaly will be studied twice - once during the active stage of their disease (pre-treatment) and a second time: 3 months after treatment of acromegaly. Controls will be studied at one time point. |
| Healthy controls | – | – |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Thirty-two study subjects will be studied: 1) patients with active acromegaly, and 2) healthy controls. Study subjects with acromegaly will be prescribed treatment for acromegaly by their healthcare providers, and this study will not interfere in anyway with clinical care and will not provide surgery, medications or other forms of clinical care.
Key inclusion criteria (3 listed)
- Ages 18 - 75 yr (both groups)
- Study subjects with active acromegaly
- Healthy controls
Key exclusion criteria (4 listed)
- Serum creatinine or alanine aminotransferase (ALT) > 2 times the upper limit of normal, metastatic cancer.
- Controls will be receiving no medications and have no chronic diseases, including cancer, hypertension or diabetes mellitus.
- Contraindications to MRI imaging (both groups) like those with certain metal implants, surgical clips or pacemakers.
- Pregnant women
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
Change in Liver Fat
Time frame: Baseline and 3-month follow-up visit
Change in intrahepatic fat after biochemical control of acromegaly
Change in Thigh Muscle Cross-sectional Area
Time frame: Baseline and 3-month follow-up visit
Change in thigh muscle cross-sectional area after biochemical control of acromegaly
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Karen Miller, 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 Acromegaly, 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 3 inclusion and 4 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 20 Jun 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?
Yes. Results are posted in the registry (first posted 20 Jun 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Liver Fat (time frame: Baseline and 3-month follow-up visit). The study lists 2 primary outcomes in all. 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 20 Jun 2018.