Pituitary Disorders Education & Support

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Effects of Growth Hormone Administration on Cardiovascular Risk Markers in Men and Women with Cured Acromegaly

This 12-month research study will evaluate the relationship between growth hormone (GH) levels and heart disease in subjects cured of acromegaly. GH is a hormone that the pituitary gland normally produces, and GH deficiency is associated with an increased risk for heart disease. This study investigates whether physiologic GH replacement therapy will reduce cardiovascular risk in men and women ages 18 to 75 with GH deficiency following cure of acromegaly. Eligible subjects may undergo 8 to 10 outpatient hospital visits which will include measurements of metabolism, body fat and muscle, as well blood tests reflecting the health of blood vessels. Subjects will be remunerated up to $300 for their participation.

We will also enroll subjects cured from acromegaly who are GH sufficient or who
are GH deficient but have a contraindication to receiving GH for a cross-sectional study involving body composition and cardiovascular risk marker measurements.

For more information, please contact Lindsay Gunnell
at (617) 724-1579 or lgunnell@partners.org

SOM 230: A Randomized, Double-Blind Study to Assess the Safety and Efficacy of Different Doses of SOM 230 (pasireotide) in Patients with Cushing’s Disease

This clinical research study is designed to investigate the effects of an investigational medication (not approved by the Food and Drug Administration), SOM 230, in patients with active Cushing’s disease. Primary treatment for Cushing’s disease is surgery to remove the tumor causing excess ACTH and cortisol secretion. SOM 230 may provide an option for medical treatment in patients with Cushing’s disease. All adult subjects who have been diagnosed with Cushing’s disease and who have not been cured may be eligible for this study. There are 17 visits over one year of study participation. Patients will receive thorough physical exams and blood testing to monitor pituitary hormones. In addition, patients will receive a total of $850 for completing the study and SOM 230 at no charge.

Please contact Karen Liebert, RN at 617-726-7473 or kpulaski@partners.org

RESEARCH STUDIES AVAILABLE

Patients may qualify for research studies in the Neuroendocrine Clinical Center. We are currently accepting the following categories of patients for screening to determine study eligibility. Depending on the study, subjects may receive free testing, medication and/or stipends.

SUBJECTS	STUDIES	CONTACT 617-726-3870
Newly diagnosed acromegaly	Evaluating preoperative medical treatments	Karen Pulaski-Liebert, R.N. Dr. Beverly M.K. Biller
Cushing’s Syndrome	Evaluating a potential new medical therapy	Karen Pulaski-Liebert, R.N. Dr. Beverly M.K. Biller
Patients with active acromegaly	Body composition and cardiovascular evaluation	Dr. Anne Klibanski Dr. Tamara Wexler
Patients with history of cured acromegaly with or without hypopituitarism	Body composition and cardiovascular evaluation GH replacement study in patients with GH deficiency	Dr. Anne Klibanski Dr. Tamara Wexler
Adolescent girls with anorexia nervosa	Evaluating bone density and the effects of estrogen replacement Newer therapeutic possibilities	Dr. Anne Klibanski Dr. Madhu Misra
Healthy adolescent girls and boys	To determine extent of growth hormone suppression following an oral glucose load	Dr. Anne Klibanski Dr. Madhu Misra
Healthy and overweight adolescent girls, ages 12-18	Investigating body weight in relation to GH and ghrelin secretion in adolescents	Dr. Anne Klibanski Dr. Madhu Misra
Women and adolescent girls with anorexia nervosa	Investigating effects of rhGH on bone metabolism	Dr. Anne Klibanski Dr. Madhu Misra Dr. Rajani Prabhakaran
Women with anorexia nervosa	New therapies	Dr. Karen K. Miller Dr. Anne Klibanski
Women and men, ages 18-45	Investigating body weight and GH secretion GH treatment in abdominal obesity	Dr. Andrea Utz Dr. Karen K. Miller
Healthy women, ages 18-45	Investigating the link between cortisol regulation and bone density	Dr. Elizabeth Lawson Dr. Karen K Miller Dr. Anne Klibanski
Women with irregular menstrual periods (hypothalamic amenorrhea), ages 18-45	Investigating the link between cortisol regulation and bone density	Dr. Elizabeth Lawson Dr. Karen K Miller Dr. Anne Klibanski
Men and Women with the Metabolic Syndrome (Obesity and Insulin resistance)	Evaluating effects of TNF-alpha neutralization, to reduce inflammation	Dr. Steven Grinspoon Dr. Stine Johnsen
HIV positive men and women with fat redistribution	Assessment of coronary artery calcification Lifestyle modification strategies, including exercise and insulin sensitization	Dr. Steven Grinspoon Dr. Janet Lo Katie Fitch, ANP
HIV positive men and women with fat redistribution	Use of GHRH, a growth hormone secretagogue, to increase endogenous GH levels, improve fat distribution and lipid profile Among patients with reduced GH response to standard GH secretion testing, use of low dose GH as above	Dr. Steven Grinspoon Janet Lo, M.D. Jim Liebau, ANP

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