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Ectopic Lipid Deposition and Insulin Resistance in After Treatment of Acromegaly

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01819883
First Posted: March 28, 2013
Last Update Posted: October 12, 2017
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.
Collaborator:
Ipsen
Information provided by (Responsible Party):
Karen Klahr Miller, MD, Massachusetts General Hospital
  Purpose
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
Acromegaly

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 Karen Klahr Miller, MD, 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 ]

Biospecimen Retention:   Samples Without DNA
Whole blood, serum

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

  Eligibility

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.
Criteria

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
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 ClinicalTrials.gov identifier (NCT number): NCT01819883


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

Responsible Party: Karen Klahr Miller, MD, Assistant Physician in Medicine, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01819883     History of Changes
Other Study ID Numbers: 2012P002517
First Submitted: March 22, 2013
First Posted: March 28, 2013
Last Update Posted: October 12, 2017
Last Verified: March 2017

Additional relevant MeSH terms:
Insulin Resistance
Acromegaly
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Bone Diseases, Endocrine
Bone Diseases
Musculoskeletal Diseases
Hyperpituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases