Ectopic Lipid Deposition and Insulin Resistance in After Treatment of Acromegaly
Verified August 2014 by Massachusetts General Hospital
Information provided by (Responsible Party):
Karen Klahr Miller, MD, Massachusetts General Hospital
First received: March 22, 2013
Last updated: August 19, 2014
Last verified: August 2014
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.
||Observational Model: Cohort
Time Perspective: Prospective
||Ectopic Lipid Deposition and Insulin Resistance in After Treatment of Acromegaly
Biospecimen Retention: Samples Without DNA
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 ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Primary Completion Date:
||April 2015 (Final data collection date for primary outcome measure)
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.
|Ages Eligible for Study:
||18 Years to 75 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
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.
- Ages 18 - 75 yr (both groups)
- Study subjects with active acromegaly
- Healthy controls
- 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
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
|Massachusetts General Hospital
|Boston, Massachusetts, United States, 02114 |
|Contact: Anu Gerweck, NP 617-724-1837 firstname.lastname@example.org |
|Principal Investigator: Karen Miller, MD |
Massachusetts General Hospital
||Karen Miller, MD
||Massachusetts General Hospital
No publications provided
||Karen Klahr Miller, MD, Assistant Physician in Medicine, Massachusetts General Hospital
History of Changes
|Other Study ID Numbers:
|Study First Received:
||March 22, 2013
||August 19, 2014
||United States: Institutional Review Board
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on November 25, 2014
Bone Diseases, Endocrine
Central Nervous System Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Nervous System Diseases