Ectopic Lipid Deposition and Insulin Resistance in After Treatment of Acromegaly

NCT01819883 | Completed Results

• 1 other identifier: 2012P002517
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Acromegaly

Outcome Measures

Primary Outcomes (2)

• Change in Liver Fat

  Change in intrahepatic fat after biochemical control of acromegaly

  Baseline and 3-month follow-up visit

• 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

Study Arms (2)

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 Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Ipsen: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Whole blood, serum

MeSH Terms

Conditions

Acromegaly

Condition Hierarchy (Ancestors)

Bone Diseases, Endocrine; Bone Diseases; Musculoskeletal Diseases; Hyperpituitarism; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Karen Miller
• Organization: Massachusetts General Hospital

KKMiller@MGH.Harvard.edu

617-726-3870

Study Officials

• Karen Miller, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Physician in Medicine

Study Record Dates

• First Submitted: March 22, 2013
• First Posted: March 28, 2013
• Study Start: April 1, 2013
• Primary Completion: March 30, 2016
• Study Completion: March 30, 2016
• Last Updated: June 20, 2018
• Results First Posted: June 20, 2018

Record last verified: 2018-06

Locations

US (1)