Ectopic Lipid Deposition and Insulin Resistance in After Treatment of Acromegaly

NCT ID: NCT01819883

Last Updated: 2018-06-20

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-04-30

Study Completion Date

2016-03-30

Brief Summary

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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.

Detailed Description

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Conditions

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Acromegaly

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Healthy controls

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Ages 18 - 75 yr (both groups)
* Study subjects with active acromegaly
* Healthy controls

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ipsen

INDUSTRY

Sponsor Role collaborator

Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Karen Klahr Miller, MD

Assistant Physician in Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Karen Miller, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

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Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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2012P002517

Identifier Type: -

Identifier Source: org_study_id

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