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Ectopic Lipid Deposition and Insulin Resistance in After Treatment of Acromegaly

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Karen Klahr Miller, MD, Massachusetts General Hospital Identifier:
First received: March 22, 2013
Last updated: September 12, 2016
Last verified: September 2016
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 Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Ectopic Lipid Deposition and Insulin Resistance in After Treatment of Acromegaly

Resource links provided by NLM:

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Change in liver fat and muscle fat over approximately three months [ Time Frame: baseline and 3 month follow-up visit ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA
Whole blood, serum

Enrollment: 46
Study Start Date: April 2013
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
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


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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.

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01819883

United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Principal Investigator: Karen Miller, MD Massachusetts General Hospital
  More Information

Responsible Party: Karen Klahr Miller, MD, Assistant Physician in Medicine, Massachusetts General Hospital Identifier: NCT01819883     History of Changes
Other Study ID Numbers: 2012P002517 
Study First Received: March 22, 2013
Last Updated: September 12, 2016
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Bone Diseases, Endocrine
Bone Diseases
Musculoskeletal Diseases
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases processed this record on October 25, 2016