Cardiovascular Risk in Growth Hormone Deficient Young Adult Males After Completing Growth Hormone Therapy

Learn more about:
Related Clinical Trial
Assessment of Adherence, Quality of Life, Clinical Response and Safety of Daily and Long-Acting Growth Hormone Therapy Impact of GH Measurements on GHD Diagnosis Fluids Administration During Combined Clonidine-Arginine Growth Hormone Stimulation Test Three Month Treatment of Growth Hormone Releasing Hormone (GHRH) in the Elderly Free Fatty Acids, Body Weight, and Growth Hormones Secretion in Children A Single Dose Trial in Healthy Caucasians and Japanese Subjects Investigating the Pharmacokinetics of Somatropin Observational Study of Norditropin NordiFlex® With NordiFlex PenMate™ The Impact of the Use of Recombinant Human Growth Hormone on ADHD Characteristics in Children and Adolescents Constructing an Insulin-Like Growth Factor-based Prediction Model Peripheral Metabolic Effects of Somatostatin Chromosome 18 Clinical Research Center The Effect of Dietary Fat Load and Physical Exercise on the Flexibility and Partitioning of Ectopic Lipids. An Observational Study on Treatment Compliance by Children Treated With Growth Hormone A Single Dose Trial in Growth Hormone Deficient Children Investigating Safety, Pharmacokinetics and Pharmacodynamics of Long Acting Growth Hormone A Study to Compare the Uptake Into the Blood of Two Strengths of Somapacitan After Injection Under the Skin in Healthy Subjects Effectiveness of Growth Hormone Releasing Hormone in Reducing Abdominal Fat in People Who Are Obese Growth Hormone as Add-on Treatment in Severe Fibromyalgia With Low IGF-1 Serum Levels (56 Characters) A Study to Optimize Growth Hormone Dosing in Children With Chronic Kidney Disease by Measuring IGF-1 Levels in Blood Safety and Efficacy of Long-term Somatropin Treatment in Adults Dose Study in Growth Hormone Deficient Adults Investigating Safety, Pharmacokinetics and Pharmacodynamics of NNC126-0083 r-hGH Liquid Multidose Versus Freeze-dried Multidose Bioequivalence Trial Effects of Growth Hormone and IGF-1 on Anabolic Signals and Stem Cell Recruitment in Human Skeletal Muscle Genotropin Study Assessing Use of Injection Pen Treatment With Recombinant Human Growth Hormone Genotonorm (Registered) In Children With Short Stature Secondary Validation of a Questionnaire That Identifies the Reasons for Non-adherence to Existing Growth Hormone Therapy Treatment of Children With Insufficient Secretion of Growth Hormone Metabolic and QOL Effects of GH Treatment in Patients With TBI and AGHD Anterior Pituitary Hormone Replacement in Traumatic Brain Injury Evolution Of Growth Rate In Children With Growth Retardation Due to Glucocorticosteroid Therapy And Treated By Genotonorm Transition Study: Growth Hormone Therapy In Partial Growth Hormone Deficient Adolescents MOD-4023 (Long-Lasting Human Growth Hormone (hGH)) Study in Growth Hormone Deficient Adults (GHDA) Safety and Efficacy Phase 2 Study of Long-acting hGH (MOD-4023) in Growth Hormone Deficient Children Inter-Assay Growth Hormone and IGF-I Variability A Study to Evaluate Growth in Participants Treated With Somatropin (Nutropin) Using NuSpin Device Cardiovascular Risk in Growth Hormone Deficient Young Adult Males After Completing Growth Hormone Therapy Easypod United States User Trial National Cooperative Growth Study in CKD Low and Conventional Dose of Somatropin in Growth Hormone Deficient Adult Patients Practicability and Acceptability of Stylomax® in Children Growth Hormone’s Effect on the Cardiovascular System Exploring Interactions Between Growth Hormone and the Microbiome Pharmacokinetics and Pharmacodynamics of Long Acting Human Growth Hormone (hGH) Product (MOD-4023) in Healthy Caucasian and Japanese Volunteers A Phase 2, Safety and Dose-Finding Study in Treatment-Naive, Pre-Pubertal, Growth Hormone-Deficient Children Phase 1 Safety Study of ALRN-5281 in Healthy Subjects Safety, Pharmacokinetics and Pharmacodynamics Study of HL-032 in Healthy Male Volunteers Effect of Somatropin on Left Ventricular Mass in Growth Hormone Deficient Adult Patients Growth Hormone and Chromosome 18q- and Abnormal Growth An Observational Study Validating a Score That Quantifies the Therapeutic Response to Treatment With Norditropin® Cross Over Convenience And Preference Study Of New Mark VII Compared To Genotropin Pen In Pediatric And Adult Subjects A Multicentre, Randomised, Open-label, Controlled Study to Evaluate the Effects of Saizen® on Cardiac Function in Growth Hormone Deficient(GHD) Subjects During the Transition Phase From Childhood to Adulthood Study of TV-1106 in Growth Hormone-Deficient Adults Long Term Follow up Study of Long-acting hGH (MOD-4023) in Growth Hormone Deficient Children Long-Term Efficacy and Safety of Growth Hormone Replacement Therapy in Chronic Heart Failure Crossover Study to Assess the Safety and Pharmacokinetic of Pegylated Somatropin(PEG Somatropin) in GHD Children Study of an Extended-Release, Crystalline Formulation of Recombinant Human Growth Hormone (ALTU-238) in Growth Hormone Deficient Adults to Determine Pharmacokinetics, Pharmacodynamics, and Drug Safety Low Dose Growth Hormone (GH) on Insulin Sensitivity and Cortisol Production Rates Gene Expression in Monocytes of Growth Hormone Deficient Children Study of Pituitary Size and Function in Familial Dwarfism of Sindh Adipocyte Function and Somtropin Deficiency Sustained Release Formulation of Somatropin (rDNA Origin)for Injection Molecular Basis of the Growth Axis in Short Stature Cardiac and Skeletal Muscle Energy Metabolism in Abnormal Growth Hormone States The Effects of Growth Hormone (GH) on Lipid Depots The Effects of TZD on Fat Metabolism and Insulin Sensitivity in GH-Replaced GHD Patients Reference Values for Body Composition Parameters and IGF-I in the Adult NordiNet® International Outcome Study Effects of Growth Hormone Supplementation to Adults With Growth Hormone Deficient on Metabolism and Adipose Tissue Molecular Phenotype Sexually Dimorphic Effects of GHRH in Adult Growth Hormone Testing Metabolic Endocrinology and Growth Hormone in Adults Growth Hormone Treatment of Young Growth Hormone-Deficient Adults Safety and Efficacy of SR-hGH (Sustained-release Human Growth Hormone, Declage Inj.) rhGH Therapy on Hepatic Drug Metabolism Skeletal Muscle Effects of GH in Boys Assessment of Cardiovascular Risk Markers in Growth Hormone Deficient Patients With Nonsecreting Pituitary Adenomas Adipose Tissue and Serum Inflammation in GH Deficiency Adipose Tissue and Circulating Markers of Inflammation in GH Deficiency and Changes With GH Therapy

Brief Title

Cardiovascular Risk in Growth Hormone Deficient Young Adult Males After Completing Growth Hormone Therapy

Official Title

Cardiovascular Risk in Growth Hormone Deficient Young Adult Males After Completing Growth Hormone Therapy.

Brief Summary

      The purpose of this study is to compare the cardiovascular risks of growth hormone deficient
      young adult males who have completed growth hormone therapy to healthy young adult males.
    

Detailed Description

      Adults with growth hormone deficiency are at risk for cardiovascular disease. What age this
      begins is not known.

      The objectives of this study are to compare the following measurements between growth hormone
      deficient young males 3-7 years post completion of growth hormone treatment and age related
      healthy controls:

        1. Carotid artery imaging

        2. Metabolic and cardiac parameters

        3. Body composition measurements
    


Study Type

Observational


Primary Outcome

Compare carotid artery intima medial thickness

Secondary Outcome

 Compare metabolic parameters and body composition measurements

Condition

Growth Hormone Deficiency


Study Arms / Comparison Groups

 1
Description:  18-25 year old males, growth hormone deficient, who completed growth hormone treatment 3-5 years prior to enrollment in study

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

24

Start Date

June 2008

Completion Date

February 2009

Primary Completion Date

February 2009

Eligibility Criteria

        Growth Hormone Deficient Inclusion Criteria:

          -  Males, 18-25 years old

          -  Completed growth hormone therapy approximately 3-5 years prior to study enrollment

          -  History of multiple pituitary hormone deficiencies or growth hormone stimulation test
             <7 at initiation of growth hormone therapy

        Healthy Control Inclusion Criteria:

          -  Males, 18-25 years old

          -  No confirmed endocrine diagnosis including Diabetes and thyroid disorders

          -  BMI - z-score within 2 SD of mean

        Exclusion Criteria:

          -  Known risk factors for cardiovascular disease (eg tobacco use, hypertension, diabetes)

          -  Family history of early cardiovascular disease (myocardial infarction or stroke
             <55years of age) in first degree family members

          -  Any implanted device

          -  Medication known to interfere with glucose or lipid metabolism or to influence blood
             pressure

          -  Chronic organ illness (eg severe asthma, hepatic or nephritic conditions)
      

Gender

Male

Ages

18 Years - 25 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Carol Huseman, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00711061

Organization ID

07-07-119E



Study Sponsor

Children's Mercy Hospital Kansas City

Collaborators

 Genentech, Inc.

Study Sponsor

Carol Huseman, MD, Principal Investigator, Children's Mercy Hospital Kansas City


Verification Date

February 2009