Ectopic Lipid Deposition and Insulin Resistance in After Treatment of Acromegaly

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01819883
Recruitment Status : Active, not recruiting
First Posted : March 28, 2013
Last Update Posted : March 3, 2017
Information provided by (Responsible Party):
Karen Klahr Miller, MD, Massachusetts General Hospital

Brief 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.

Condition or disease

Study Type : Observational
Actual Enrollment : 46 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Ectopic Lipid Deposition and Insulin Resistance in After Treatment of Acromegaly
Study Start Date : April 2013
Actual Primary Completion Date : January 2017
Estimated Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

Primary Outcome Measures :
  1. Change in liver fat and muscle fat over approximately three months [ Time Frame: baseline and 3 month follow-up visit ]

Biospecimen Retention:   Samples Without DNA
Whole blood, serum

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Responsible Party: Karen Klahr Miller, MD, Assistant Physician in Medicine, Massachusetts General Hospital Identifier: NCT01819883     History of Changes
Other Study ID Numbers: 2012P002517
First Posted: March 28, 2013    Key Record Dates
Last Update Posted: March 3, 2017
Last Verified: March 2017

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