Clinical trial: Growth Hormone Administration and Its Effects on Cardiovascular Risk Factors in Growth Hormone Deficient Women (NCT00136032)

Eligibility criteria:
Inclusion Criteria:

          -  GH deficiency due to pituitary or hypothalamic tumors or disease affecting this area.
             Subjects will have been treated with medication, surgery, radiation, or a combination
             of these. GH deficiency will be defined as a peak plasma GH of less than 5 ng/ml in
             response to insulin tolerance testing or growth hormone releasing hormone (GHRH) plus
             arginine stimulation test. In subjects with suspected hypothalamic dysfunction the
             arginine plus L-dopa stimulation test may be used, with a cutoff of 1.7 ng/ml for
             diagnosis of GH deficiency. Partial GH deficiency will be defined as a GH peak of 5 to
             9 ng/ml (inclusive) during insulin tolerance testing or GHRH plus arginine testing.

          -  GH deficiency will also be diagnosed if insulin-like growth factor-I (IGF-I) levels
             are below 2 standard deviations for the age-sex normal range in a patient with at
             least two documented hormone deficiencies.

          -  Subjects must have evidence of a stable pituitary mass (for at least 12 months) if
             there is a history of a tumor except in the case of ACTH-producing microadenomas,
             where no follow-up imaging is required after cure.

          -  Subjects age 40 and over must have a screening mammogram if they have not already had
             one within one year prior to their baseline visit

        Exclusion Criteria:

          -  Active Cushing's disease within 1 year

          -  History of acromegaly

          -  Untreated thyroid or adrenal insufficiency. Subjects on replacement therapy must be
             stable for at least 3 months prior to entry into the study.

          -  History of malignancy except for skin cancer and except for childhood solid malignancy
             with documented cure for > 10 years prior to starting the study

          -  Hemoglobin <10.0 gm/dl

          -  Hepatic or renal disease (SGPT/SGOT > 3x upper limit of normal (ULN) or creatinine
             levels >2.5 mg/dl)

          -  Congestive heart failure (CHF) (New York Heart Association's classification system
             Class II-IV CHF will be excluded)

          -  History of unstable cardiovascular disease (coronary artery or cerebrovascular
             disease) or symptoms within one year prior to entry into the study

          -  Diabetes mellitus

          -  Pregnancy or nursing

          -  Active carpal tunnel syndrome
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 65 Years

Patient description (medical language): A 33-year-old woman comes to clinic complaining of progressive fatigue, decreased appetite, and 11-lb weight loss in the past 2 months.  She uses levothyroxine because of the previously diagnosed Hashimoto disease. She has no other medical conditions and does not use tobacco, alcohol, or illicit drugs.  Physical examination shows a generalized increase in pigmentation of the skin.  Measurement of serum cortisol before and after administration of exogenous adrenocorticotropic hormone (ACTH) shows no difference in the levels. Stable glucocorticoid replacement therapy starts for her with the diagnosis for primary adrenal insufficiency (Addison disease)

Patient description (patient's own words): I went to the clinic because I was really suffering from fatigue and decreased appetite and I also lost 11 pounds over the past two months. I'm just 33 years old so that's not normal, especially for a woman. I take levothyroxine because I have been diagnosed with Hashimoto disease. I don't have any other medical condition, and I don't smoke I don't drink, and I don't do drugs. They also did my physical examination and they saw that I had an increase in pigmentation of my skin. They measured my cortisol level before and after giving me some ACTH hormone, and the results came back with no difference whatsoever. The doctor told me I have Addison disease and put me under glucocorticoid therapy.

Does the patient match the trial criteria? 0