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Effect of Growth Hormone (GH) on Cardiac Echos in GH Deficient Patients After Acromegaly Treatment

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01302652
First Posted: February 24, 2011
Last Update Posted: March 18, 2015
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.
Information provided by (Responsible Party):
Karen Klahr Miller, MD, Massachusetts General Hospital
  Purpose
The purpose of this research study is to study the effects of growth hormone (GH) replacement on the heart. The investigators will study these effects in people who have been cured of acromegaly and then have developed growth hormone deficiency (GHD, not enough growth hormone).

Condition
Acromegaly

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Effects of Physiologic Growth Hormone Administration on Echocardiographic Parameters in Subjects With Growth Hormone Deficiency Following Cure of Acromegaly

Resource links provided by NLM:


Further study details as provided by Karen Klahr Miller, MD, Massachusetts General Hospital:

Primary Outcome Measures:
  • Change from Baseline in Echocardiographic Findings at One Year [ Time Frame: baseline and one year ]

Biospecimen Retention:   Samples Without DNA
serum and plasma

Enrollment: 20
Study Start Date: February 2011
Study Completion Date: February 2015
Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
GH deficient after acromegaly cure (on GH replacement)
Men and women with growth hormone deficiency following cure of acromegaly who are receiving growth hormone treatment.
GH deficient after acromegaly cure (not on GH replacement)
Men and women with growth hormone deficiency following cure of acromegaly who are not receiving growth hormone treatment.

  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:   No
Sampling Method:   Non-Probability Sample
Study Population
Men and women between age 18-75 who have developed growth hormone deficiency after history of acromegaly with biochemical cure.
Criteria

Inclusion Criteria:

  • age 18-75
  • history of acromegaly with biochemical cure
  • growth hormone deficiency

Exclusion Criteria:

  • untreated thyroid disease within the past 3 months
  • untreated adrenal insufficiency within the past 3 months
  • uncontrolled hypertension
  • congestive heart failure
  • gonadal steroid therapy within the past 3 months
  • pregnancy or nursing
  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): NCT01302652


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

Responsible Party: Karen Klahr Miller, MD, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01302652     History of Changes
Other Study ID Numbers: 2010P002188
First Submitted: February 18, 2011
First Posted: February 24, 2011
Last Update Posted: March 18, 2015
Last Verified: March 2015

Keywords provided by Karen Klahr Miller, MD, Massachusetts General Hospital:
acromegaly
growth hormone
growth hormone deficiency

Additional relevant MeSH terms:
Acromegaly
Bone Diseases, Endocrine
Bone Diseases
Musculoskeletal Diseases
Hyperpituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs


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