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NCT01819883 Clinical Trial

Ectopic Lipid Deposition and Insulin Resistance in After Treatment of Acromegaly

Acromegaly Clinical Trial

Official title:
Ectopic Lipid Deposition and Insulin Resistance in After Treatment of Acromegaly

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01819883
Other study ID # 2012P002517
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 2013
Est. completion date March 30, 2016

Study information
Verified date June 2018
Source Massachusetts General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date March 30, 2016
Est. primary completion date March 30, 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Massachusetts General Hospital Boston Massachusetts

Sponsors (2)
Lead Sponsor Collaborator
Massachusetts General Hospital Ipsen

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in Liver Fat Change in intrahepatic fat after biochemical control of acromegaly Baseline and 3-month follow-up visit
Primary Change in Thigh Muscle Cross-sectional Area Change in thigh muscle cross-sectional area after biochemical control of acromegaly Baseline and 3-month follow-up visit
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