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Trial Outcomes & Findings for Growth Hormone and Endothelial Function in Children (NCT NCT00373386)

NCT ID: NCT00373386

Last Updated: 2018-05-30

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

9 participants

Primary outcome timeframe

3 months

Results posted on

2018-05-30

Participant Flow

Participant milestones

Participant milestones
Measure
Growth Hormone Treatment
Growth hormone 0.3 mg/kg/week given 6 days per week
Overall Study
STARTED
9
Overall Study
COMPLETED
9
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Growth Hormone and Endothelial Function in Children

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Growth Hormone Treatment
n=9 Participants
Age, Continuous
11.9 years
STANDARD_DEVIATION 2.4 • n=99 Participants
Sex: Female, Male
Female
1 Participants
n=99 Participants
Sex: Female, Male
Male
8 Participants
n=99 Participants
Region of Enrollment
United States
9 participants
n=99 Participants
Post occlusion forearm blood flow
22.8 ml/dl*min
STANDARD_DEVIATION 9.9 • n=99 Participants
Glucose
82 mg/dl
STANDARD_DEVIATION 9 • n=99 Participants
insulin
5.7 uU/ml
STANDARD_DEVIATION 4.8 • n=99 Participants
Homa
21 mg*uU/dl*ml
STANDARD_DEVIATION 21 • n=99 Participants
triglycerides
115 mg/dl
STANDARD_DEVIATION 150 • n=99 Participants
ldl
127 mg/dl
STANDARD_DEVIATION 51 • n=99 Participants
HDL
44 mg/dl
STANDARD_DEVIATION 6 • n=99 Participants
SBP
96 mmHg
STANDARD_DEVIATION 9 • n=99 Participants
DBP
47 mmHg
STANDARD_DEVIATION 9 • n=99 Participants

PRIMARY outcome

Timeframe: 3 months

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.

Outcome measures

Outcome measures
Measure
Growth Hormone Treatment
n=9 Participants
9 subject (8 male 1 female). 8 with isolated GH deficiency (peak GH level less than 10 ng/ml in response to arginine-insulin stimulation with normal cortisol response and thyroid function tests) 1 with panhypopitutarism on cortisol and thyroxine replacement
Reactive Hyperemic Response After 3 Months of Growth Hormone
21.077 ml/dl min
Standard Error 1.937

SECONDARY outcome

Timeframe: 3 months

Plasma glucose

Outcome measures

Outcome measures
Measure
Growth Hormone Treatment
n=9 Participants
9 subject (8 male 1 female). 8 with isolated GH deficiency (peak GH level less than 10 ng/ml in response to arginine-insulin stimulation with normal cortisol response and thyroid function tests) 1 with panhypopitutarism on cortisol and thyroxine replacement
Glucose
87 mg/dl
Standard Deviation 9

SECONDARY outcome

Timeframe: 3 months

Plasma insulin

Outcome measures

Outcome measures
Measure
Growth Hormone Treatment
n=9 Participants
9 subject (8 male 1 female). 8 with isolated GH deficiency (peak GH level less than 10 ng/ml in response to arginine-insulin stimulation with normal cortisol response and thyroid function tests) 1 with panhypopitutarism on cortisol and thyroxine replacement
Insulin
11.3 uU/ml
Standard Error 6

SECONDARY outcome

Timeframe: 3 months

Insulin resistance

Outcome measures

Outcome measures
Measure
Growth Hormone Treatment
n=9 Participants
9 subject (8 male 1 female). 8 with isolated GH deficiency (peak GH level less than 10 ng/ml in response to arginine-insulin stimulation with normal cortisol response and thyroid function tests) 1 with panhypopitutarism on cortisol and thyroxine replacement
HOMA
43 mg uU/dl ml
Standard Error 8

SECONDARY outcome

Timeframe: 3 months

Plasma Triglycerides

Outcome measures

Outcome measures
Measure
Growth Hormone Treatment
n=9 Participants
9 subject (8 male 1 female). 8 with isolated GH deficiency (peak GH level less than 10 ng/ml in response to arginine-insulin stimulation with normal cortisol response and thyroid function tests) 1 with panhypopitutarism on cortisol and thyroxine replacement
Triglycerides
75 mg/dl
Standard Error 20

SECONDARY outcome

Timeframe: 3 months

LDL level

Outcome measures

Outcome measures
Measure
Growth Hormone Treatment
n=9 Participants
9 subject (8 male 1 female). 8 with isolated GH deficiency (peak GH level less than 10 ng/ml in response to arginine-insulin stimulation with normal cortisol response and thyroid function tests) 1 with panhypopitutarism on cortisol and thyroxine replacement
LDL
110 mg/dl
Standard Error 9

SECONDARY outcome

Timeframe: 3 months

Plasma HDL

Outcome measures

Outcome measures
Measure
Growth Hormone Treatment
n=9 Participants
9 subject (8 male 1 female). 8 with isolated GH deficiency (peak GH level less than 10 ng/ml in response to arginine-insulin stimulation with normal cortisol response and thyroid function tests) 1 with panhypopitutarism on cortisol and thyroxine replacement
HDL
47 mg/dl
Standard Error 3

Adverse Events

Growth Hormone Treatment

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Robert P. Hoffman MD

Research Institute at Nationwide Children's hospital

Phone: 614-722-4425

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place