Effects of Growth Hormone Administration on Cardiovascular Risk in Cured Acromegalics With Growth Hormone Deficiency

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT00182091
• Date of registration: 14/09/2005
• Prospective Registration: No
• Primary sponsor: Massachusetts General Hospital
• Public title: Effects of Growth Hormone Administration on Cardiovascular Risk in Cured Acromegalics With Growth Hormone Deficiency
• Scientific title: Effects of Physiologic Growth Hormone Administration on Cardiovascular Risk in Subjects With Growth Hormone Deficiency Following Cure of Acromegaly
• Date of first enrolment: August 2004
• Target sample size: 75
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00182091
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Participant).
• Phase: N/A

Countries of recruitment

United States

Contacts

• Name: Anne Klibanski, MD
• Affiliation: Massachusetts General Hospital

Key inclusion & exclusion criteria

Inclusion Criteria:

- Age 18-75

- History of acromegaly with biochemical cure documented with a normal oral glucose
tolerance test (OGTT) and/or a non-elevated IGF-I without concurrent use of
somatostatin analogs, dopamine agonists or GH receptor antagonists. Subjects will have
been treated with medication, surgery, radiation, or a combination of these

- At the time of enrollment a minimum of 6 months must have elapsed since surgery.

- No malignancy on colonoscopy performed since the diagnosis of acromegaly

- GHD due to surgical or radiation treatment

- GHD will be defined as a peak plasma GH of less than 5 ng/ml in response to an insulin
tolerance test or a GH-releasing hormone (GHRH) plus arginine stimulation test

- GHD will also be diagnosed if IGF-I levels are below 2 standard deviations for the
age-sex normal range in a patient with at least two other documented anterior
pituitary hormone deficiencies

Exclusion Criteria:

- 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 non-melanoma skin cancer

- Hemoglobin <11.0 gm/dl

- Uncontrolled hypertension

- Hepatic or renal disease (aspartate aminotransferase (AST) or alanine aminotransferase
(ALT) > 3x upper limit of normal (ULN) or creatinine level >2.5 mg/dl)

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

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

- Initiation or discontinuation of gonadal steroid therapy within 3 months of entry

- Diabetes mellitus, impaired fasting glucose, impaired glucose tolerance

- Pregnancy or nursing

- Active carpal tunnel syndrome

- Subjects who have received GH therapy within one year prior to entry into the study

- For female subjects age >40 a screening mammogram must have been obtained within one
year prior to their baseline visit.

- Sensitivity to m-cresol



Age minimum: 18 Years
Age maximum: 85 Years
Gender: All

Health Condition(s) or Problem(s) studied

Acromegaly

Growth Hormone Deficiency

Pituitary Disease

Intervention(s)

Drug: Recombinant human growth hormone

Drug: Saline

Primary Outcome(s)

Change in High-sensitivity C-reactive Protein [Time Frame: baseline and 6 months]

Secondary Outcome(s)

Change in Total Abdominal Adipose Tissue [Time Frame: baseline and 6 months]

Change in Total Fat Mass [Time Frame: baseline and 6 months]

Change in Visceral Abdominal Adipose Tissue [Time Frame: baseline and 6 months]

Secondary ID(s)

2004p-001078

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 28/05/2012
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00182091