This trial is active, not recruiting.

Condition acromegaly
Sponsor Massachusetts General Hospital
Collaborator Ipsen
Start date April 2013
End date January 2017
Trial size 46 participants
Trial identifier NCT01819883, 2012P002517


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
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.

Primary Outcomes

Change in liver fat and muscle fat over approximately three months
time frame: baseline and 3 month follow-up visit

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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

Additional Information

Official title Ectopic Lipid Deposition and Insulin Resistance in After Treatment of Acromegaly
Principal investigator Karen Miller, MD
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Massachusetts General Hospital.