Trial Outcomes & Findings for Safety Profile of Insulin Like Growth Factor-1 (IGF-I) Administration in Adolescents (NCT NCT00516386)
NCT ID: NCT00516386
Last Updated: 2021-11-18
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
16 participants
Primary outcome timeframe
Baseline and 7-10 days
Results posted on
2021-11-18
Participant Flow
Sixteen anorexia nervosa patients between the ages of 12-18 years were recruited. Patients were determined by their psychiatrists to meet criteria for AN as described in the Diagnostic and Statistical Manual of Mental Disorders (a).
Four subjects were not interested in the study after the screen, and two were lost to follow-up.
Participant milestones
| Measure |
RhIGF-1
All study subjects were administered rhIGF-1 at a dose of 35-40 mcg/k/dose twice daily SC for 7-10 days.
|
|---|---|
|
Overall Study
STARTED
|
16
|
|
Overall Study
COMPLETED
|
10
|
|
Overall Study
NOT COMPLETED
|
6
|
Reasons for withdrawal
| Measure |
RhIGF-1
All study subjects were administered rhIGF-1 at a dose of 35-40 mcg/k/dose twice daily SC for 7-10 days.
|
|---|---|
|
Overall Study
not interested in the study
|
4
|
|
Overall Study
Lost to Follow-up
|
2
|
Baseline Characteristics
Safety Profile of Insulin Like Growth Factor-1 (IGF-I) Administration in Adolescents
Baseline characteristics by cohort
| Measure |
RhIGF-1
n=16 Participants
All study subjects were administered rhIGF-1 at a dose of 35-40 mcg/k/dose twice daily SC for 7-10 days.
|
|---|---|
|
Age, Categorical
<=18 years
|
16 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
16.2 years
STANDARD_DEVIATION 0.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 7-10 daysPopulation: 16 subjects were screened for the study, and 10 completed the study. 10 were analyzed.
Outcome measures
| Measure |
RhIGF-1
n=10 Participants
All study subjects were administered rhIGF-1 at a dose of 35-40 mcg/k/dose twice daily SC for 7-10 days.
|
|---|---|
|
Change in Levels of Insulin Like Growth Factor-1 (IGF-I) Following Recombinant Human (rh) IGF-1 Administration in Girls With Anorexia Nervosa
|
542.9 ng/ml
Standard Error 40.9
|
SECONDARY outcome
Timeframe: Baseline and 7-10 daysOutcome measures
| Measure |
RhIGF-1
n=10 Participants
All study subjects were administered rhIGF-1 at a dose of 35-40 mcg/k/dose twice daily SC for 7-10 days.
|
|---|---|
|
Change in Levels of N-terminal Propeptide of Type 1 Procollagen (P1NP) Following rhIGF-1 Administration in Girls With Anorexia Nervosa
|
39.3 ng/ml
Standard Error 9.3
|
Adverse Events
RhIGF-1
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
RhIGF-1
n=16 participants at risk
All study subjects were administered rhIGF-1 at a dose of 35-40 mcg/k/dose twice daily SC for 7-10 days.
|
|---|---|
|
Metabolism and nutrition disorders
Hospitalization for weight gain
|
6.2%
1/16 • Number of events 1 • One year
|
Other adverse events
| Measure |
RhIGF-1
n=16 participants at risk
All study subjects were administered rhIGF-1 at a dose of 35-40 mcg/k/dose twice daily SC for 7-10 days.
|
|---|---|
|
General disorders
Headaches
|
25.0%
4/16 • Number of events 4 • One year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place