Trial Outcomes & Findings for Growth Hormone, Cardiovascular Risk, and Visceral Adiposity (NCT NCT00131378)
NCT ID: NCT00131378
Last Updated: 2016-03-11
Results Overview
6 month change in HsCRP (primary cardiovascular risk endpoint)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
142 participants
Primary outcome timeframe
Measured at baseline and month 6
Results posted on
2016-03-11
Participant Flow
Participant milestones
| Measure |
Female on GH
Participants received growth hormone replacement therapy. The starting dose was 4 micrograms/kg per day and they were titrated within the normal range based on blood levels.
Nutropin AQ growth hormone : Participants gave themselves injections of growth hormone every night for 6 months.
|
Female on Placebo
Participants received placebo.
Placebo Growth Hormone : Participants gave themselves injections of placebo every night for 6 months.
|
Male on GH
Participants received growth hormone replacement therapy. The starting dose was 2 micrograms/kg per day and they were titrated within the normal range based on blood levels.
Nutropin AQ growth hormone : Participants gave themselves injections of growth hormone every night for 6 months.
|
Male on Placebo
Participants received placebo.
Placebo Growth Hormone : Participants gave themselves injections of placebo every night for 6 months.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
40
|
40
|
32
|
30
|
|
Overall Study
COMPLETED
|
29
|
22
|
22
|
21
|
|
Overall Study
NOT COMPLETED
|
11
|
18
|
10
|
9
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Growth Hormone, Cardiovascular Risk, and Visceral Adiposity
Baseline characteristics by cohort
| Measure |
Female on GH
n=40 Participants
Participants received growth hormone replacement therapy. The starting dose was 4 micrograms/kg per day and they were titrated within the normal range based on blood levels.
Nutropin AQ growth hormone : Participants gave themselves injections of growth hormone every night for 6 months.
|
Female on Placebo
n=40 Participants
Participants received placebo.
Placebo Growth Hormone : Participants gave themselves injections of placebo every night for 6 months.
|
Male on GH
n=32 Participants
Participants received growth hormone replacement therapy. The starting dose was 2 micrograms/kg per day and they were titrated within the normal range based on blood levels.
Nutropin AQ growth hormone : Participants gave themselves injections of growth hormone every night for 6 months.
|
Male on Placebo
n=30 Participants
Participants received placebo.
Placebo Growth Hormone : Participants gave themselves injections of placebo every night for 6 months.
|
Total
n=142 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
40 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
142 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Continuous
|
35.7 years
STANDARD_DEVIATION 1.1 • n=5 Participants
|
36.1 years
STANDARD_DEVIATION 1.1 • n=7 Participants
|
32.4 years
STANDARD_DEVIATION 1.2 • n=5 Participants
|
34.3 years
STANDARD_DEVIATION 1.1 • n=4 Participants
|
34.6 years
STANDARD_DEVIATION 1.13 • n=21 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
80 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
62 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
40 participants
n=5 Participants
|
40 participants
n=7 Participants
|
32 participants
n=5 Participants
|
30 participants
n=4 Participants
|
142 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Measured at baseline and month 6Population: ITT
6 month change in HsCRP (primary cardiovascular risk endpoint)
Outcome measures
| Measure |
Male on GH
n=32 Participants
Participants received growth hormone replacement therapy. The starting dose was 2 micrograms/kg per day and they were titrated within the normal range based on blood levels.
Nutropin AQ growth hormone : Participants gave themselves injections of growth hormone every night for 6 months.
|
Male on Placebo
n=30 Participants
Participants received placebo.
Placebo Growth Hormone : Participants gave themselves injections of placebo every night for 6 months.
|
Female on GH
n=40 Participants
Participants received growth hormone replacement therapy. The starting dose was 4 micrograms/kg per day and they were titrated within the normal range based on blood levels.
Nutropin AQ growth hormone : Participants gave themselves injections of growth hormone every night for 6 months.
|
Female on Placebo
n=40 Participants
Participants received placebo.
Placebo Growth Hormone : Participants gave themselves injections of placebo every night for 6 months.
|
|---|---|---|---|---|
|
HsCRP
|
-1.1 mg/L
Standard Error 0.5
|
0.5 mg/L
Standard Error 0.3
|
-1.3 mg/L
Standard Error 0.2
|
-0.3 mg/L
Standard Error 0.2
|
PRIMARY outcome
Timeframe: Measured at baseline and month 66 month change in total abdominal fat (primary body composition endpoint)
Outcome measures
| Measure |
Male on GH
n=40 Participants
Participants received growth hormone replacement therapy. The starting dose was 2 micrograms/kg per day and they were titrated within the normal range based on blood levels.
Nutropin AQ growth hormone : Participants gave themselves injections of growth hormone every night for 6 months.
|
Male on Placebo
n=40 Participants
Participants received placebo.
Placebo Growth Hormone : Participants gave themselves injections of placebo every night for 6 months.
|
Female on GH
Participants received growth hormone replacement therapy. The starting dose was 4 micrograms/kg per day and they were titrated within the normal range based on blood levels.
Nutropin AQ growth hormone : Participants gave themselves injections of growth hormone every night for 6 months.
|
Female on Placebo
Participants received placebo.
Placebo Growth Hormone : Participants gave themselves injections of placebo every night for 6 months.
|
|---|---|---|---|---|
|
Total Abdominal Fat
|
-28.0 cm^2
Standard Error 9.7
|
1.5 cm^2
Standard Error 11
|
—
|
—
|
PRIMARY outcome
Timeframe: Measured at baseline and month 66 month change in visceral abdominal fat (primary body composition endpoint)
Outcome measures
| Measure |
Male on GH
n=32 Participants
Participants received growth hormone replacement therapy. The starting dose was 2 micrograms/kg per day and they were titrated within the normal range based on blood levels.
Nutropin AQ growth hormone : Participants gave themselves injections of growth hormone every night for 6 months.
|
Male on Placebo
n=30 Participants
Participants received placebo.
Placebo Growth Hormone : Participants gave themselves injections of placebo every night for 6 months.
|
Female on GH
Participants received growth hormone replacement therapy. The starting dose was 4 micrograms/kg per day and they were titrated within the normal range based on blood levels.
Nutropin AQ growth hormone : Participants gave themselves injections of growth hormone every night for 6 months.
|
Female on Placebo
Participants received placebo.
Placebo Growth Hormone : Participants gave themselves injections of placebo every night for 6 months.
|
|---|---|---|---|---|
|
Abdominal Fat
|
-15.9 cm^2
Standard Error 6.3
|
-0.2 cm^2
Standard Error 7.2
|
—
|
—
|
SECONDARY outcome
Timeframe: Measured at baseline and month 66 month change in 2-hour glucose (primary insulin resistance endpoint)
Outcome measures
| Measure |
Male on GH
n=32 Participants
Participants received growth hormone replacement therapy. The starting dose was 2 micrograms/kg per day and they were titrated within the normal range based on blood levels.
Nutropin AQ growth hormone : Participants gave themselves injections of growth hormone every night for 6 months.
|
Male on Placebo
n=30 Participants
Participants received placebo.
Placebo Growth Hormone : Participants gave themselves injections of placebo every night for 6 months.
|
Female on GH
n=40 Participants
Participants received growth hormone replacement therapy. The starting dose was 4 micrograms/kg per day and they were titrated within the normal range based on blood levels.
Nutropin AQ growth hormone : Participants gave themselves injections of growth hormone every night for 6 months.
|
Female on Placebo
n=40 Participants
Participants received placebo.
Placebo Growth Hormone : Participants gave themselves injections of placebo every night for 6 months.
|
|---|---|---|---|---|
|
Measure of Insulin Resistance
|
5.3 mg/dL
Standard Error 5.6
|
-12.5 mg/dL
Standard Error 5.8
|
18.6 mg/dL
Standard Error 6.3
|
-0.9 mg/dL
Standard Error 8.2
|
SECONDARY outcome
Timeframe: Measured at baseline and month 66-month change in IGF-1 levels
Outcome measures
| Measure |
Male on GH
n=32 Participants
Participants received growth hormone replacement therapy. The starting dose was 2 micrograms/kg per day and they were titrated within the normal range based on blood levels.
Nutropin AQ growth hormone : Participants gave themselves injections of growth hormone every night for 6 months.
|
Male on Placebo
n=30 Participants
Participants received placebo.
Placebo Growth Hormone : Participants gave themselves injections of placebo every night for 6 months.
|
Female on GH
n=40 Participants
Participants received growth hormone replacement therapy. The starting dose was 4 micrograms/kg per day and they were titrated within the normal range based on blood levels.
Nutropin AQ growth hormone : Participants gave themselves injections of growth hormone every night for 6 months.
|
Female on Placebo
n=40 Participants
Participants received placebo.
Placebo Growth Hormone : Participants gave themselves injections of placebo every night for 6 months.
|
|---|---|---|---|---|
|
Insulin-like Growth Factor-1 (IGF-1) Levels
|
179.0 ng/mL
Standard Error 31.5
|
9.9 ng/mL
Standard Error 7.8
|
106.5 ng/mL
Standard Error 17.5
|
-20.8 ng/mL
Standard Error 7.6
|
Adverse Events
Female on GH
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Female on Placebo
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Male on GH
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Male on Placebo
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Female on GH
n=40 participants at risk
Participants received growth hormone replacement therapy. The starting dose was 4 micrograms/kg per day and they were titrated within the normal range based on blood levels.
Nutropin AQ growth hormone : Participants gave themselves injections of growth hormone every night for 6 months.
|
Female on Placebo
n=40 participants at risk
Participants received placebo.
Placebo Growth Hormone : Participants gave themselves injections of placebo every night for 6 months.
|
Male on GH
n=32 participants at risk
Participants received growth hormone replacement therapy. The starting dose was 2 micrograms/kg per day and they were titrated within the normal range based on blood levels.
Nutropin AQ growth hormone : Participants gave themselves injections of growth hormone every night for 6 months.
|
Male on Placebo
n=30 participants at risk
Participants received placebo.
Placebo Growth Hormone : Participants gave themselves injections of placebo every night for 6 months.
|
|---|---|---|---|---|
|
General disorders
Breast Cancer
|
0.00%
0/40
|
2.5%
1/40 • Number of events 1
|
0.00%
0/32
|
0.00%
0/30
|
|
Injury, poisoning and procedural complications
MVA - motor vehicle accident
|
0.00%
0/40
|
0.00%
0/40
|
0.00%
0/32
|
3.3%
1/30 • Number of events 1
|
Other adverse events
| Measure |
Female on GH
n=40 participants at risk
Participants received growth hormone replacement therapy. The starting dose was 4 micrograms/kg per day and they were titrated within the normal range based on blood levels.
Nutropin AQ growth hormone : Participants gave themselves injections of growth hormone every night for 6 months.
|
Female on Placebo
n=40 participants at risk
Participants received placebo.
Placebo Growth Hormone : Participants gave themselves injections of placebo every night for 6 months.
|
Male on GH
n=32 participants at risk
Participants received growth hormone replacement therapy. The starting dose was 2 micrograms/kg per day and they were titrated within the normal range based on blood levels.
Nutropin AQ growth hormone : Participants gave themselves injections of growth hormone every night for 6 months.
|
Male on Placebo
n=30 participants at risk
Participants received placebo.
Placebo Growth Hormone : Participants gave themselves injections of placebo every night for 6 months.
|
|---|---|---|---|---|
|
Endocrine disorders
Abnormal Glucose Measurements
|
5.0%
2/40 • Number of events 2
|
0.00%
0/40
|
12.5%
4/32 • Number of events 4
|
3.3%
1/30 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Carpel Tunnel Symptoms
|
0.00%
0/40
|
0.00%
0/40
|
9.4%
3/32 • Number of events 3
|
3.3%
1/30 • Number of events 1
|
|
General disorders
Breast Calcification on Mammogram
|
2.5%
1/40 • Number of events 1
|
0.00%
0/40
|
0.00%
0/32
|
0.00%
0/30
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.5%
1/40 • Number of events 1
|
0.00%
0/40
|
0.00%
0/32
|
0.00%
0/30
|
|
Reproductive system and breast disorders
Cervical HPV
|
0.00%
0/40
|
2.5%
1/40 • Number of events 1
|
0.00%
0/32
|
0.00%
0/30
|
|
Endocrine disorders
Goiter
|
0.00%
0/40
|
2.5%
1/40 • Number of events 1
|
0.00%
0/32
|
0.00%
0/30
|
|
Reproductive system and breast disorders
Breast Lump
|
0.00%
0/40
|
2.5%
1/40 • Number of events 1
|
0.00%
0/32
|
0.00%
0/30
|
|
Cardiac disorders
New onset atrial fibrillation
|
0.00%
0/40
|
0.00%
0/40
|
0.00%
0/32
|
3.3%
1/30 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place