Adult Growth Hormone Deficiency and Cardiovascular Risk

Columbia University

Status and phase: Terminated; Phase 4

Conditions: Growth Hormone Deficiency

Treatments: Procedure: Blood draws; Drug: growth hormone releasing hormone (GHRH) & arginine; Procedure: Endothelial cell biopsy; Procedure: MRI; Procedure: Carotid ultrasound

Study type: Interventional

Funder types: Other

Identifiers

NCT00720902

AAAB9681 (Serono-001)

Serono-001 (Other Identifier)

Details and patient eligibility

About

This protocol will assess the cardiovascular risk associated with growth hormone deficiency in adults. We will use multiple modalities to assess risk for heart attacks or strokes including blood work, ultrasound, MRI and endothelial cell biopsies in both patients who are growth hormone deficient and in patients with normal growth hormone secretion. We hypothesize that adults with growth hormone deficiency will have results suggestive of an increased risk for cardiovascular disease.

Full description

Subjects will first be tested for possible growth hormone deficiency. This will be done by administering two intravenous medications that should stimulate growth hormone secretion and we will measure growth hormone in the blood every 30 minutes following the administration. Once we have the results on enough subjects we will split the cohort into those subjects who are growth hormone deficient and those who have normal growth hormone. The two groups will each undergo various tests all designed to assess some component of cardiovascular risk. Ultimately we will compare the results of each test to see if those who are growth hormone deficient have an increased risk for cardiovascular disease.

Enrollment: 7 patients

Sex: All

Ages: 19 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults 19 years or older who have undergone transsphenoidal surgery for a clinically non-secreting pituitary adenoma

Exclusion criteria

• Currently taking growth hormone, radiation therapy in the past 5 years, changes in dose of other pituitary hormone replacement therapy in past 3 months, taking hydrocortisone (or its equivalent) at a dose of > 30 mg/day, pregnant or nursing women

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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7 participants in 2 patient groups

A - Normal growth hormone secretion

Active Comparator group

Description:

Patients who have undergone transsphenoidal surgery for a pituitary adenoma and have normal growth hormone secretion: Subjects will undergo a clinical exam with vital signs and blood draws, anthropometric measurements and skin fold thickness assessments. Subjects will also undergo GH stimulation testing with growth hormone releasing hormone (GHRH) \& arginine, MRI and MR spectroscopy, carotid ultrasound, and have an endothelial cell biopsy.

Treatment:

Procedure: Blood draws

Procedure: MRI

Procedure: Carotid ultrasound

Procedure: Endothelial cell biopsy

Drug: growth hormone releasing hormone (GHRH) & arginine

B - Growth hormone deficient

Active Comparator group

Description:

Patients who have undergone transsphenoidal surgery for pituitary adenoma who are growth hormone deficient: Subjects will undergo a clinical exam with vital signs and blood draws, anthropometric measurements and skin fold thickness assessments. Subjects will also undergo GH stimulation testing with growth hormone releasing hormone (GHRH) \& arginine, MRI and MR spectroscopy, carotid ultrasound, and have an endothelial cell biopsy.

Treatment:

Procedure: Blood draws

Procedure: MRI

Procedure: Carotid ultrasound

Procedure: Endothelial cell biopsy

Drug: growth hormone releasing hormone (GHRH) & arginine