Ectopic Lipid Deposition and Insulin Resistance in After Treatment of Acromegaly

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Massachusetts General Hospital
Sponsor:
Collaborator:
Ipsen
Information provided by (Responsible Party):
Karen Klahr Miller, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01819883
First received: March 22, 2013
Last updated: February 4, 2014
Last verified: February 2014
  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 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


Estimated Enrollment: 52
Study Start Date: April 2013
Estimated Primary Completion Date: April 2015 (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

Ages Eligible for Study:   18 Years to 75 Years
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.

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Morbid obesity (BMI ≥ 40 kg/m2), 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01819883

Contacts
Contact: Anu Gerweck, NP 617-724-1837 avgerweck@partners.org

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Anu Gerweck, NP    617-724-1837    avgerweck@partners.org   
Principal Investigator: Karen Miller, MD         
Sponsors and Collaborators
Massachusetts General Hospital
Ipsen
Investigators
Principal Investigator: Karen Miller, MD Massachusetts General Hospital
  More Information

No publications provided

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
Study First Received: March 22, 2013
Last Updated: February 4, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on July 24, 2014