Trial Outcomes & Findings for Differential Effects of rhGH vs. rhIGF-1 on Cardiovascular Risk Factors (NCT NCT00684957)
NCT ID: NCT00684957
Last Updated: 2024-07-17
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
5 participants
Primary outcome timeframe
2 months
Results posted on
2024-07-17
Participant Flow
Participant milestones
| Measure |
Recombinant Human Growth Hormone First, Then Recombinant Human IGF-1
Subjects will take Recombinant Human Growth Hormone (rhGH) for eight weeks followed by a two month wash out period and then will cross over to Recombinant Human IGF-1 (rhIGF1) for eight weeks.
rhGH dose: 300 mcg sc qd (which may be increased to 400 mcg sc qd after 4 weeks)
rhIGF1 dose: 30 µg/kg for first 4 weeks (may be increased thereafter based on IGF-1 levels)
|
Recombinant Human IGF-1 First, Then Recombinant Human Growth Hormone
Subjects will take Recombinant Human IGF-1 (rhIGF1) for eight weeks followed by a two month wash out period and then will cross over to Recombinant Human Growth Hormone (rhGH) for eight weeks.
rhGH dose: 300 mcg sc qd (which may be increased to 400 mcg sc qd after 4 weeks)
rhIGF1 dose: 30 µg/kg for first 4 weeks (may be increased thereafter based on IGF-1 levels)
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
3
|
|
Overall Study
COMPLETED
|
0
|
2
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
Recombinant Human Growth Hormone First, Then Recombinant Human IGF-1
Subjects will take Recombinant Human Growth Hormone (rhGH) for eight weeks followed by a two month wash out period and then will cross over to Recombinant Human IGF-1 (rhIGF1) for eight weeks.
rhGH dose: 300 mcg sc qd (which may be increased to 400 mcg sc qd after 4 weeks)
rhIGF1 dose: 30 µg/kg for first 4 weeks (may be increased thereafter based on IGF-1 levels)
|
Recombinant Human IGF-1 First, Then Recombinant Human Growth Hormone
Subjects will take Recombinant Human IGF-1 (rhIGF1) for eight weeks followed by a two month wash out period and then will cross over to Recombinant Human Growth Hormone (rhGH) for eight weeks.
rhGH dose: 300 mcg sc qd (which may be increased to 400 mcg sc qd after 4 weeks)
rhIGF1 dose: 30 µg/kg for first 4 weeks (may be increased thereafter based on IGF-1 levels)
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
Differential Effects of rhGH vs. rhIGF-1 on Cardiovascular Risk Factors
Baseline characteristics by cohort
| Measure |
Study Subjects
n=5 Participants
Includes all subjects enrolled into the study.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 2 monthsPopulation: Levels of cardiovascular serum risk markers were not measured and thus not analyzed due to poor enrollment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 monthsPopulation: Visceral adiposity, intrahepatic and intramyocllular lipids were not measured/collected and thus not analyzed due to poor enrollment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 monthsPopulation: Endothelial cell function was not measured/collected and thus not analyzed due to poor enrollment.
Outcome measures
Outcome data not reported
Adverse Events
Recombinant Human Growth Hormone First, Then Recombinant Human IGF-1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Recombinant Human IGF-1 First, Then Recombinant Human Growth Hormone
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place