Growth Hormone and Endothelial Function in Children

NCT00373386 | Completed Phase 4 Results

• 1 other identifier: Peds15
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

Objective: This study is designed to determine whether growth hormone treatment in children 8 to 18 years of age alters function of the lining of the arteries. This may play a role in increasing or decreasing the risk of heart disease. Methods. Twenty children, for whom growth hormone therapy will be otherwise provided, will be studied before and 3 months after starting growth hormone. Subjects can be on other hormonal replacements but no other medications. Each study will be done in the fasting state. The blood vessel function will be determined by measuring the change in forearm blood flow before and after blocking flow to the arm for 5 minutes. Blood will be drawn after the test to measure glucose, insulin and fats.

Conditions

Growth Hormone Deficiency; Panhypopituitarism; Short Stature

Keywords

growth hormone; endothelial function

Outcome Measures

Primary Outcomes (1)

• Reactive Hyperemic Response After 3 Months of Growth Hormone

  Forearm blood flow (FBF) was measured using strain gauge venous occlusion plethysmography using a Hokanson EC6 plethysmograph (DE Hokanson Inc, Bellevue, WA) in the left arm. With this technique sphygmomanometric cuffs were placed on the arm at the wrist and on the upper arm. During measurement the wrist cuff was inflated to 200 mmHg to occlude flow to the hand which is primarily skin blood flow and the upper arm cuff is inflated to 40 mmHG for 10 out of every 15 second to occlude venous return. FBF was obtained by measuring arm expansion with an indium-in-silastic strain gauge. Data was recorded using PowerLab and Chart 4.0 (AD Instruments, Grand Junction, CO) on a Power Mac G4 computer (Apple, Cupertino, CA).For each subject two minutes of baseline FBF were recorded and then the upper arm cuff was inflated to 200 mmHg pressure for five minutes to occlude flow to the arm. It was then released and forearm blood flow was measured for the next minute.

  3 months

Secondary Outcomes (6)

• Glucose

  3 months

• Insulin

  3 months

• HOMA

  3 months

• Triglycerides

  3 months

• LDL

  3 months

Study Arms (1)

Growth Hormone

EXPERIMENTAL

Growth hormone treatment 0.3 mg/kg/min

Drug: growth hormone

Interventions

growth hormone DRUG

Growth Hormone treatment

Growth Hormone

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• isolated growth hormone deficiency (peak growth hormone level less than 10 ng/ml in response to arginine-insulin stimulation with cortisol responses and thyroid function tests), panhypopituitarism with appropriate thyroxine (normal free T4 level) and cortisol replacement (8-12 mg/m2/day) and non classic growth hormone deficiency (growth velocity less than 5 cm/year; peak growth hormone \>10 ng/ml).

You may not qualify if:

• Taking medications other than the appropriate hormonal replacement(L-thyroxine, cortisol, estrogen or testosterone, DDAVP)

Sponsors & Collaborators

• Ohio State University: lead
• Nationwide Children's Hospital: collaborator

Study Sites (1)

Ohio State University

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Dwarfism, Pituitary; Combined Pituitary Hormone Deficiency; Dwarfism

Interventions

Growth Hormone

Condition Hierarchy (Ancestors)

Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Bone Diseases, Endocrine; Hypopituitarism; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Anterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Limitations and Caveats

Small sample size

Results Point of Contact

• Title: Robert P. Hoffman MD
• Organization: Research Institute at Nationwide Children's hospital

robert.hoffman@nationwidechildrens.org

614-722-4425

Study Officials

• Robert P Hoffman, MD

  Ohio State University

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 7, 2006
• First Posted: September 8, 2006
• Study Start: January 1, 2005
• Primary Completion: June 1, 2007
• Study Completion: December 1, 2007
• Last Updated: May 30, 2018
• Results First Posted: May 30, 2018

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will share

Locations

US (1)