Phase 2 N=6 Role of Growth Hormone Antagonism in Modulating Insulin Sensitivity in Subjects With Pre-diabetes
Diabetes · Metabolic Syndrome · Insulin Resistance
Primary: Insulin Sensitivity — 3.06; 3.33 units on a scale
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Phase 3 N=92 Long-Term Treatment With rhIGF-1 in GHIS
Growth Hormone Insensitivity Syndrome
Primary: Annualized Height Velocity Up to 12 Years — 2.6; 8.0; 5.9; 5.5 centimeter per year (cm/y)
Phase 3 N=136 Prepubertal Children With Growth Failure Associated With Primary Insulin-Like Growth Factor-1 (IGF-1) Deficiency
Growth Disorders · Insulin-Like Growth Factor-1 Deficiency
Primary: Height Velocity During the First Year - Intent to Treat (ITT)Population — 5.2; 6.9; 7.7 cm/yr — p=<0.0001
N/A N=56 Physiologic Growth Hormone Effects in HIV Lipodystrophy
AIDS · HIV Infections
Primary: Change in Visceral Adipose Tissue Area From Baseline to 18 Months — -22; -4 centimeters squared — p=0.049
N/A N=28 Growth Hormone Feedback to Insulin-like Growth Factor-I (IGF-1) and Oral Glucose Tolerance Test (OGTT)
Acromegaly · Type 2 Diabetes Mellitus
Primary: Percentage With Growth Hormone (GH) Suppression to < 0.4 ng/ml — 0; 7; 8 Participants
N/A N=25 Effects of Short-term Growth Hormone in HIV-infected Patients
HIV Lipodystrophy
Primary: Overnight Mean Growth Hormone Secretion After 2 Weeks of Study Drug — 0.23; 0.07; 1.24 ng/mL — p=0.01
Phase 2 N=77 Growth Hormone and/or Rosiglitazone for HIV-Associated Increased Abdominal Fat and Insulin Resistance
HIV-Associated Lipodystrophy Syndrome · Insulin Resistance · HIV Infections
Primary: Change in Insulin Sensitivity — 0.20; 1.44; -0.63; 0.14 uU*10^-4*min*ml^-1
Phase 2 N=22 Growth Hormone Treatment in Patients With Aggrecan (ACAN) Deficiency
Short Stature
Primary: Height Standard Deviation Score — -2.52; -1.57; -1.19; -1.09 standard deviation score
N/A N=142 Growth Hormone, Cardiovascular Risk, and Visceral Adiposity
Obesity
Primary: HsCRP — -1.1; 0.5; -1.3; -0.3 mg/L
Phase 3 N=113 Growth Hormone in Neuroendocrine Dysfunction With Severe Fibromyalgia Syndrome
Fibromyalgia
Primary: Percentage of Participants With Less Than 11 Tender Points at Month 6 — 20; 22 Percentage of participants
Phase 2 N=56 Growth Hormone Deficiency in Chronic Heart Failure: A Preliminary Trial
Heart Failure · Growth Hormone Deficiency · Ischemic Heart Disease
Primary: Peak VO2 — 14.5; 12.9 ml/kg/min
Phase 3 N=46 Growth Retardation In Children With Special Pathological Conditions Or Disease
Endocrine System Diseases
Primary: Change From Baseline in Annual Growth Rate Standard Deviation Score (SDS) for Chronological Age (CA) at Month 36 in Intent-to-Treat (ITT) Population — -1.29; 2.36 SDS
N/A N=77 Study of Growth Hormone and Bone in Obesity
Obesity · Osteopenia
Primary: Bone Mineral Density — -0.015; -0.008 grams/cm^2
N/A N=24 Growth Hormone as a Determinant of Weight Regulation
Obesity
Primary: 24 Hour Average Plasma Growth Hormone Concentration — 0.4; 1.2; 4.1 ng/mL
Phase 2 N=6 Growth Hormone Treatment in Children With Phelan McDermid Syndrome
Phelan McDermid Syndrome
Primary: ABC - Social Withdrawal Subscale — 10.31; 4.6; 14.8; 6.2 score on a scale
N/A N=43 The Glucagon Stimulation Test for Evaluation of Adult Growth Hormone Deficiency and Adrenocorticotropic Axis
Adult Growth Hormone Deficiency · Hypothalamic-pituitary Disorders
Primary: Peak GH Level in Adult Patients With Hypothalamic-pituitary Disorders and 1-2 Pituitary Hormone Deficiency (PHD). — 0.9; 0.6; 0.7 ng/mL
Phase 3 N=42 Growth Hormone Therapy in Osteogenesis Imperfecta
Osteogenesis Imperfecta
Primary: Proportion of Subjects Who Met Criteria of Increase in Growth Rate Since Baseline. — 25 Participants
Phase 4 N=17 A Study to Optimize Growth Hormone Dosing in Children With Chronic Kidney Disease by Measuring IGF-1 Levels in Blood
Kidney Failure, Chronic · Growth Hormone Deficiency
Primary: The Change in Amount of Insulin Like Growth Factor (IGF-I) Generated (Day 8-day 1) — 115; 129 mcg/L
Phase 3 N=45 Recombinant Human Insulin-Like Growth Factor (rhIGF-1) Treatment of Short Stature Associated With IGF-1 Deficiency
Insulin-Like Growth Factor-1 Deficiency · Growth Disorders
Primary: Height Velocity From Pretreatment (Week 0) to Week 34 — 7.0 centimeters per year (cm/yr)
Phase 3 N=91 Saizen in Intra-uterine Growth Retardation
Children Born With Serious Intra-uterine Growth Retardation
Primary: Final Height — 145.90; 150.06; 153.27; 155.59 cm
Phase 3 N=11 Growth Hormone Use in Adults With Prader-Willi Syndrome
Prader-Willi Syndrome
Primary: Body Composition — 51.2; 48.5; 52.1 percentage of body fat — p=<0.05
Phase 4 N=115 Growth Hormone Treatment for the Prevention of Short Stature in Young Girls With Turner Syndrome Before the Age of 4 Years
Turner's Syndrome
Primary: Height SDS at Year 4 — -1.35; -2.44 standard deviation score
Phase 4 N=23 The Effect of Dipeptidyl Peptidase 4 Inhibition on Growth Hormone Secretion in Women With Polycystic Ovarian Syndrome
Polycystic Ovary Syndrome
Primary: Mean Overnight Growth Hormone Levels — 0.85; 0.84 ng/mL — p=0.918
Phase 4 N=9 Growth Hormone and Endothelial Function in Children
Growth Hormone Deficiency · Panhypopituitarism · Short Stature
Primary: Reactive Hyperemic Response After 3 Months of Growth Hormone — 21.077 ml/dl min — p=0.644
Phase 4 N=20 Endocrine Dysfunction and Growth Hormone Deficiency in Children With Optic Nerve Hypoplasia
Growth Hormone Deficiency · Septo-Optic Dysplasia · Hypopituitarism
Primary: Change in Anthropometric Measures Over Time — 1.97; -0.61; 1.39; 1.22 Z-score
N/A N=15 Growth Hormone Treatment on Phosphocreatine Recovery in Obesity
Obese · Growth Hormone Secretion Abnormality
Primary: Phosphocreatine Recovery — 0.74 correlation coefficient — p=0.02
Phase 2 N=7 IGF-1 Treatment for Individuals With Short Stature Due to PAPP-A2 Deficiency
Short Stature
Primary: Height Velocity — 3.0; 4.3; 6.2; 4.8 cm/y
Phase 3 N=208 Genotropin Treatment in Short Prepubertal Children With Intra-Uterine Growth Retardation
Growth Disorders · Intrauterine Growth Retardation
Primary: Change From Baseline in Annual Growth Rate Measured at 2 Years Following Treatment With Genotonorm — 3.07; 3.97; 2.84 cm/year — p=0.02922
Phase 2 N=20 Trial of Growth Hormone Therapy in Pediatric Crohn's Disease
Crohn's Disease
Primary: Crohn's Disease Histologic Index of Severity (CDHIS) — 7; 8; 6; 8 scores on a scale
Phase 4 N=69 Long-Term Growth and Skeletal Effects of Early Growth Hormone Treatment in Turner Syndrome
Turner Syndrome
Primary: Most Mature Height Standard Deviation Score (SDS) — -1.37; -1.60 standard deviation score