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Hormone Therapy

growth hormone for Human Growth Hormone Deficiency

N/A
Waitlist Available
Led By Luisa M Rodriguez
Research Sponsored by Baylor College of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 13 hours fasting
Awards & highlights

Study Summary

The purpose of the proposed study is to investigate the effects of rhGH treatment on glucose, protein and fat metabolism in GHD children. Specifically, the investigators will measure the rates of glucose production, gluconeogenesis, glycogenolysis, insulin sensitivity and glucagon response before and after treatment with rhGH. In addition, the investigators will study changes in protein and fat metabolism pre and post rhGH therapy in children with GHD. The findings in the GHD children will be compared to those of a control group of age and sex matched healthy children. Hypotheses: H1- The fraction of glucose derived from gluconeogenesis is decreased and that from glycogenolysis is increased in the post-absorptive state in untreated GHD children when compared to healthy children. H2- Treatment with rhGH will not change the overall glucose turnover but will normalize the abnormal partitioning of gluconeogenesis and glycogenolysis in GHD children. H3- GH replacement will reduce urea production and increase estimates of protein synthesis, thus optimizing the availability of amino acids for growth. H4- Untreated children with GHD after an overnight fast will have an increased glucagon challenge response that will decrease after 8 weeks of treatment with rhGH. Specific Aims: In healthy and newly diagnosed GHD children the investigators will: 1. Measure the Glucose Production Rate (GPR) 2. Determine the fraction of glucose derived from gluconeogenesis and glycogenolysis 3. Estimate insulin sensitivity 4. Measure proteolysis and protein oxidation 5. Determine glucagon challenge response after an overnight fast. The above-mentioned parameters will be re-evaluated in the children with GHD after 8 weeks of rhGH therapy.

Eligible Conditions
  • Human Growth Hormone Deficiency

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~13 hours fasting
This trial's timeline: 3 weeks for screening, Varies for treatment, and 13 hours fasting for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Glucose Production rate,Gluconeogenesis, glycogenolysis.
Secondary outcome measures
Glucagon response
Insulin resistance
Proteolysis

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: growth hormoneExperimental Treatment1 Intervention
children with proven growth hormone deficiency
Group II: healthy controlsActive Control1 Intervention
No growth hormone is given

Find a Location

Who is running the clinical trial?

Genentech, Inc.Industry Sponsor
1,539 Previous Clinical Trials
567,669 Total Patients Enrolled
9 Trials studying Human Growth Hormone Deficiency
668 Patients Enrolled for Human Growth Hormone Deficiency
Baylor College of MedicineLead Sponsor
1,001 Previous Clinical Trials
6,001,932 Total Patients Enrolled
Luisa M RodriguezPrincipal InvestigatorBaylor College of Medicine

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What site did they apply to?
Baylor College of Medicine
What portion of applicants met pre-screening criteria?
Did not meet criteria

Why did patients apply to this trial?

I’m trying to find any way for my son to reach his full growth potential and not be made fun of for how small/short he is.
PatientReceived no prior treatments
~1 spots leftby Apr 2025