304-C03/L3301n: Effects of Growth Hormone on Glucose and Protein Metabolism in Children With Growth Hormone Deficiency

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT00362063
• Date of registration: 08/08/2006
• Prospective Registration: No
• Primary sponsor: Baylor College of Medicine
• Public title: 304-C03/L3301n: Effects of Growth Hormone on Glucose and Protein Metabolism in Children With Growth Hormone Deficiency
• Scientific title: Effects of Growth Hormone on Glucose and Protein Metabolism in Children With Growth Hormone Deficiency
• Date of first enrolment: January 2006
• Target sample size: 20
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT00362063
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

United States

Contacts

• Name: Luisa M Rodriguez
• Affiliation: Baylor College of Medicine

Key inclusion & exclusion criteria

Inclusion Criteria:

The study population will consist of children with newly diagnosed growth hormone
deficiency (GHD), between the ages of 1-17 years. The clinical evidence will be provided by
one or more of the following criteria: delayed bone age, growth deceleration, short stature
(more than 2 SD bellow the mean for the subject's age) and/ or height more than1.5 SD below
the predicted mid-parental height. The biochemical diagnosis of GHD will be established by
an abnormal growth hormone stimulation test and low IGF-1 and IGFBP-3 (growth factors). The
growth hormone stimulation test will be performed following the standard Endocrinology
Clinic protocol. The growth hormone stimulation test is considered the "gold standard" to
diagnose Growth Hormone Deficiency. This test is part of the standard clinical practice to
diagnosed GHD. An abnormal test is defined as a post stimulation Growth Hormone level less
than10 ng/mL.

The control group will include healthy children between the ages of 1-17 years, not taking
any medication with a normal weight for height and growth factors (IGF-1 and IGFBP-3)."

Exclusion Criteria:

The exclusion criteria will include for both groups age less than 1 or more than 17 y/o,
evidence of anemia (hemoglobin less tan 12 mg/dl), the use of medications that can directly
impact blood sugar (steroids, oral contraceptives etc), history or proof of chemical abuse,
lack of supportive family environment, allergies to local anesthetics and elevated liver
enzymes. The GHD children will have a head MRI, and children with evidence of tumors or
space occupying lesions will be excluded. GHD subjects with adrenal insufficiency and or
hypothyroidism. will not be considered for the study.



Age minimum: 1 Month
Age maximum: 17 Years
Gender: All

Health Condition(s) or Problem(s) studied

Growth Hormone Deficiency

Intervention(s)

Drug: growth hormone (Nutropin)

Primary Outcome(s)

Glucose Production rate,Gluconeogenesis, glycogenolysis. [Time Frame: 13 hours fasting]

Secondary Outcome(s)

Proteolysis [Time Frame: 13 hours fasting]

Insulin resistance [Time Frame: 13 hours fasting]

Glucagon response [Time Frame: for 2hrs after glucagon administration]

Secondary ID(s)

H-14859

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Genentech, Inc.