Trial Outcomes & Findings for Neuroendocrine Modulation of Metabolic Effects in Overweight Adolescents (NCT NCT00140842)
NCT ID: NCT00140842
Last Updated: 2021-11-02
Results Overview
Peak growth hormone (GH) on the GH stimulation test is a measure of the adequacy of GH secretion.
COMPLETED
47 participants
Baseline
2021-11-02
Participant Flow
17 obese and 30 normal-weight adolescents (12-18 yr old) were screened for study eligibility.15 obese adolescents completed the study visit. These subjects were matched for race, ethnicity, and bone age to normal-weight adolescents from the pool of screened subjects.
Participant milestones
| Measure |
Normal-weight Girls
Normal weight girls 12-18 years old
|
Obese Girls
Obese adolescents between 12-18 years old.
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
|
Overall Study
COMPLETED
|
15
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Neuroendocrine Modulation of Metabolic Effects in Overweight Adolescents
Baseline characteristics by cohort
| Measure |
Normal-weight Girls
n=15 Participants
Normal-weight girls were required to have a BMI between the 15th-85th percentiles
|
Obese Girls
n=15 Participants
Obese girls were required to have a BMI above the 95th percentile
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
15.9 years
STANDARD_DEVIATION 1.7 • n=5 Participants
|
14.0 years
STANDARD_DEVIATION 1.9 • n=7 Participants
|
14.9 years
STANDARD_DEVIATION 3.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: BaselinePopulation: This was a cross-sectional study to compare differences in growth hormone (GH) secretory status in relation to body composition in obese versus normal-weight girls. This was a pilot study and the analysis was performed using a Student t-test to compare means across groups
Peak growth hormone (GH) on the GH stimulation test is a measure of the adequacy of GH secretion.
Outcome measures
| Measure |
Normal-weight Girls
n=15 Participants
Normal-weight girls were required to have a BMI between the 15th-85th percentiles
|
Obese Girls
n=15 Participants
Obese girls were required to have a BMI above the 95th percentile
|
|---|---|---|
|
Peak Growth Hormone (GH) on the GH Stimulation Test
|
40.1 ng/ml
Standard Deviation 16.1 • Interval 0.0 to 100.0
|
25.2 ng/ml
Standard Deviation 21.8
|
SECONDARY outcome
Timeframe: BaselinePopulation: The analysis was completed on the 30 participants as per protocol
Visceral adipose tissue was measured using magnetic resonance imaging at the level of the fourth lumbar vertebra (L4)
Outcome measures
| Measure |
Normal-weight Girls
n=15 Participants
Normal-weight girls were required to have a BMI between the 15th-85th percentiles
|
Obese Girls
n=15 Participants
Obese girls were required to have a BMI above the 95th percentile
|
|---|---|---|
|
Visceral Adipose Tissue
|
19 grams
Standard Deviation 7.5 • Interval 0.0 to 100.0
|
42.7 grams
Standard Deviation 17.0 • Interval 0.0 to 100.0
|
Adverse Events
Normal-weight Girls
Obese Girls
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