Trial Outcomes & Findings for Growth Hormone Feedback to Insulin-like Growth Factor-I (IGF-1) and Oral Glucose Tolerance Test (OGTT) (NCT NCT00915954)
NCT ID: NCT00915954
Last Updated: 2019-07-09
Results Overview
Subjects underwent recombinant insulin like growth factor 1 (rhIGF1) suppression testing and growth hormone levels were measured at time 0, 15, 30, 60, 90, 120, and 180 minutes after injection of rhIGF-1. A response \</= 0.4 ng/ml is considered a normal response in the healthy control and diabetic control subjects. The percentage of subjects with a normal GH suppression to \</= 0.4 ng/ml was calculated.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
28 participants
Primary outcome timeframe
Before injection and at time 15, 30, 60, 90, 120 and 180 minutes after rhIGF-1 injection on week 4
Results posted on
2019-07-09
Participant Flow
Participant milestones
| Measure |
Active Acromegaly
Placebo, oral glucose tolerance test, and subcutaneous administration of recombinant human IGF-1 will be given at visits 2, 3, and 4 respectively. All visits will be performed within a 4 week period.
Oral Glucose Tolerance Test: Participants will have their blood drawn for a baseline value and then will be asked to drink a beverage with 75 grams of sugar. Blood will then be drawn every 30 minutes for 2 hours.
Subcutaneous administration of recombinant human IGF-1: Participants will receive a subcutaneous injection of recombinant human IGF-1 followed by a series of blood draws.
Placebo: Participants will receive a subcutaneous injection of saline followed by a series of blood draws.
|
Type 2 Diabetes Mellitus(DM)
Placebo, oral glucose tolerance test, and subcutaneous administration of recombinant human IGF-1 will be given at visits 2, 3, and 4 respectively. All visits will be performed within a 4 week period.
Oral Glucose Tolerance Test: Participants will have their blood drawn for a baseline value and then will be asked to drink a beverage with 75 grams of sugar. Blood will then be drawn every 30 minutes for 2 hours.
Subcutaneous administration of recombinant human IGF-1: Participants will receive a subcutaneous injection of recombinant human IGF-1 followed by a series of blood draws.
Placebo: Participants will receive a subcutaneous injection of saline followed by a series of blood draws.
|
Heathly Controls
Placebo, oral glucose tolerance test, and subcutaneous administration of recombinant human IGF-1 will be given at visits 2, 3, and 4 respectively. All visits will be performed within a 4 week period.
Oral Glucose Tolerance Test: Participants will have their blood drawn for a baseline value and then will be asked to drink a beverage with 75 grams of sugar. Blood will then be drawn every 30 minutes for 2 hours.
Subcutaneous administration of recombinant human IGF-1: Participants will receive a subcutaneous injection of recombinant human IGF-1 followed by a series of blood draws.
Placebo: Participants will receive a subcutaneous injection of saline followed by a series of blood draws.
|
|---|---|---|---|
|
Overall Study
STARTED
|
10
|
8
|
10
|
|
Overall Study
COMPLETED
|
10
|
8
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Growth Hormone Feedback to Insulin-like Growth Factor-I (IGF-1) and Oral Glucose Tolerance Test (OGTT)
Baseline characteristics by cohort
| Measure |
Active Acromegaly
n=10 Participants
Placebo, oral glucose tolerance test, and subcutaneous administration of recombinant human IGF-1 will be given at visits 2, 3, and 4 respectively. All visits will be performed within a 4 week period.
Oral Glucose Tolerance Test: Participants will have their blood drawn for a baseline value and then will be asked to drink a beverage with 75 grams of sugar. Blood will then be drawn every 30 minutes for 2 hours.
Subcutaneous administration of recombinant human IGF-1: Participants will receive a subcutaneous injection of recombinant human IGF-1 followed by a series of blood draws.
Placebo: Participants will receive a subcutaneous injection of saline followed by a series of blood draws.
|
Type 2 Diabetes Mellitus(DM)
n=8 Participants
Placebo, oral glucose tolerance test, and subcutaneous administration of recombinant human IGF-1 will be given at visits 2, 3, and 4 respectively. All visits will be performed within a 4 week period.
Oral Glucose Tolerance Test: Participants will have their blood drawn for a baseline value and then will be asked to drink a beverage with 75 grams of sugar. Blood will then be drawn every 30 minutes for 2 hours.
Subcutaneous administration of recombinant human IGF-1: Participants will receive a subcutaneous injection of recombinant human IGF-1 followed by a series of blood draws.
Placebo: Participants will receive a subcutaneous injection of saline followed by a series of blood draws.
|
Heathly Controls
n=10 Participants
Placebo, oral glucose tolerance test, and subcutaneous administration of recombinant human IGF-1 will be given at visits 2, 3, and 4 respectively. All visits will be performed within a 4 week period.
Oral Glucose Tolerance Test: Participants will have their blood drawn for a baseline value and then will be asked to drink a beverage with 75 grams of sugar. Blood will then be drawn every 30 minutes for 2 hours.
Subcutaneous administration of recombinant human IGF-1: Participants will receive a subcutaneous injection of recombinant human IGF-1 followed by a series of blood draws.
Placebo: Participants will receive a subcutaneous injection of saline followed by a series of blood draws.
|
Total
n=28 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
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Age, Continuous
|
47 years
STANDARD_DEVIATION 18 • n=5 Participants
|
54 years
STANDARD_DEVIATION 9 • n=7 Participants
|
38 years
STANDARD_DEVIATION 17 • n=5 Participants
|
46 years
STANDARD_DEVIATION 17 • n=4 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
8 participants
n=7 Participants
|
10 participants
n=5 Participants
|
28 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Before injection and at time 15, 30, 60, 90, 120 and 180 minutes after rhIGF-1 injection on week 4Subjects underwent recombinant insulin like growth factor 1 (rhIGF1) suppression testing and growth hormone levels were measured at time 0, 15, 30, 60, 90, 120, and 180 minutes after injection of rhIGF-1. A response \</= 0.4 ng/ml is considered a normal response in the healthy control and diabetic control subjects. The percentage of subjects with a normal GH suppression to \</= 0.4 ng/ml was calculated.
Outcome measures
| Measure |
Active Acromegaly
n=10 Participants
Placebo, oral glucose tolerance test, and subcutaneous administration of recombinant human IGF-1 will be given at visits 2, 3, and 4 respectively. All visits will be performed within a 4 week period.
Oral Glucose Tolerance Test: Participants will have their blood drawn for a baseline value and then will be asked to drink a beverage with 75 grams of sugar. Blood will then be drawn every 30 minutes for 2 hours.
Subcutaneous administration of recombinant human IGF-1: Participants will receive a subcutaneous injection of recombinant human IGF-1 followed by a series of blood draws.
Placebo: Participants will receive a subcutaneous injection of saline followed by a series of blood draws.
|
Type 2 Diabetes Mellitus(DM)
n=8 Participants
Placebo, oral glucose tolerance test, and subcutaneous administration of recombinant human IGF-1 will be given at visits 2, 3, and 4 respectively. All visits will be performed within a 4 week period.
Oral Glucose Tolerance Test: Participants will have their blood drawn for a baseline value and then will be asked to drink a beverage with 75 grams of sugar. Blood will then be drawn every 30 minutes for 2 hours.
Subcutaneous administration of recombinant human IGF-1: Participants will receive a subcutaneous injection of recombinant human IGF-1 followed by a series of blood draws.
Placebo: Participants will receive a subcutaneous injection of saline followed by a series of blood draws.
|
Heathly Controls
n=10 Participants
Placebo, oral glucose tolerance test, and subcutaneous administration of recombinant human IGF-1 will be given at visits 2, 3, and 4 respectively. All visits will be performed within a 4 week period.
Oral Glucose Tolerance Test: Participants will have their blood drawn for a baseline value and then will be asked to drink a beverage with 75 grams of sugar. Blood will then be drawn every 30 minutes for 2 hours.
Subcutaneous administration of recombinant human IGF-1: Participants will receive a subcutaneous injection of recombinant human IGF-1 followed by a series of blood draws.
Placebo: Participants will receive a subcutaneous injection of saline followed by a series of blood draws.
|
|---|---|---|---|
|
Percentage With Growth Hormone (GH) Suppression to < 0.4 ng/ml
|
0 Participants
|
7 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Before injection at time 0 and then at 15, 30, 60, 90, 120, and 180 minutes after injection for week 2, 3, and 4 for each cohort for placebo, OGTT, and rhIGF1, respectively.IGFBP1 levels were measured at time 0 prior to the injection and measured at 15, 30, 60, 90, 120, and 180 minutes after injection. The area under the curve of IGFBP1 was calculated for each subject and the medians calculated for each cohort during the placebo, OGTT, and rhIGF1 tests.
Outcome measures
| Measure |
Active Acromegaly
n=10 Participants
Placebo, oral glucose tolerance test, and subcutaneous administration of recombinant human IGF-1 will be given at visits 2, 3, and 4 respectively. All visits will be performed within a 4 week period.
Oral Glucose Tolerance Test: Participants will have their blood drawn for a baseline value and then will be asked to drink a beverage with 75 grams of sugar. Blood will then be drawn every 30 minutes for 2 hours.
Subcutaneous administration of recombinant human IGF-1: Participants will receive a subcutaneous injection of recombinant human IGF-1 followed by a series of blood draws.
Placebo: Participants will receive a subcutaneous injection of saline followed by a series of blood draws.
|
Type 2 Diabetes Mellitus(DM)
n=8 Participants
Placebo, oral glucose tolerance test, and subcutaneous administration of recombinant human IGF-1 will be given at visits 2, 3, and 4 respectively. All visits will be performed within a 4 week period.
Oral Glucose Tolerance Test: Participants will have their blood drawn for a baseline value and then will be asked to drink a beverage with 75 grams of sugar. Blood will then be drawn every 30 minutes for 2 hours.
Subcutaneous administration of recombinant human IGF-1: Participants will receive a subcutaneous injection of recombinant human IGF-1 followed by a series of blood draws.
Placebo: Participants will receive a subcutaneous injection of saline followed by a series of blood draws.
|
Heathly Controls
n=10 Participants
Placebo, oral glucose tolerance test, and subcutaneous administration of recombinant human IGF-1 will be given at visits 2, 3, and 4 respectively. All visits will be performed within a 4 week period.
Oral Glucose Tolerance Test: Participants will have their blood drawn for a baseline value and then will be asked to drink a beverage with 75 grams of sugar. Blood will then be drawn every 30 minutes for 2 hours.
Subcutaneous administration of recombinant human IGF-1: Participants will receive a subcutaneous injection of recombinant human IGF-1 followed by a series of blood draws.
Placebo: Participants will receive a subcutaneous injection of saline followed by a series of blood draws.
|
|---|---|---|---|
|
Median Insulin Like Growth Factor Binding Protein 1 (IGFBP-1) Area Under the Curve in Response to Placebo, Oral Glucose Tolerance Test (OGTT), and rhIGF1 Suppression Testing
Placebo
|
10927 ng*min/mL
Interval 2963.0 to 85103.0
|
5079 ng*min/mL
Interval 2317.0 to 12915.0
|
9105 ng*min/mL
Interval 2645.0 to 16808.0
|
|
Median Insulin Like Growth Factor Binding Protein 1 (IGFBP-1) Area Under the Curve in Response to Placebo, Oral Glucose Tolerance Test (OGTT), and rhIGF1 Suppression Testing
OGTT
|
5603 ng*min/mL
Interval 3758.0 to 63248.0
|
2538 ng*min/mL
Interval 2207.0 to 28208.0
|
4266 ng*min/mL
Interval 637.0 to 27870.0
|
|
Median Insulin Like Growth Factor Binding Protein 1 (IGFBP-1) Area Under the Curve in Response to Placebo, Oral Glucose Tolerance Test (OGTT), and rhIGF1 Suppression Testing
IGF-1 suppression test
|
10901 ng*min/mL
Interval 3098.0 to 62873.0
|
7347 ng*min/mL
Interval 1578.0 to 10911.0
|
7681 ng*min/mL
Interval 3318.0 to 16256.0
|
SECONDARY outcome
Timeframe: Measured at 120 minutes after injection for week 2, 3, and 4 for each cohort for placebo, OGTT, and rhIGF1, respectively.Insulin levels were measured at time 120 minutes after injection. Median insulin was calculated for each cohort during the placebo, OGTT, and rhIGF1 tests.
Outcome measures
| Measure |
Active Acromegaly
n=10 Participants
Placebo, oral glucose tolerance test, and subcutaneous administration of recombinant human IGF-1 will be given at visits 2, 3, and 4 respectively. All visits will be performed within a 4 week period.
Oral Glucose Tolerance Test: Participants will have their blood drawn for a baseline value and then will be asked to drink a beverage with 75 grams of sugar. Blood will then be drawn every 30 minutes for 2 hours.
Subcutaneous administration of recombinant human IGF-1: Participants will receive a subcutaneous injection of recombinant human IGF-1 followed by a series of blood draws.
Placebo: Participants will receive a subcutaneous injection of saline followed by a series of blood draws.
|
Type 2 Diabetes Mellitus(DM)
n=8 Participants
Placebo, oral glucose tolerance test, and subcutaneous administration of recombinant human IGF-1 will be given at visits 2, 3, and 4 respectively. All visits will be performed within a 4 week period.
Oral Glucose Tolerance Test: Participants will have their blood drawn for a baseline value and then will be asked to drink a beverage with 75 grams of sugar. Blood will then be drawn every 30 minutes for 2 hours.
Subcutaneous administration of recombinant human IGF-1: Participants will receive a subcutaneous injection of recombinant human IGF-1 followed by a series of blood draws.
Placebo: Participants will receive a subcutaneous injection of saline followed by a series of blood draws.
|
Heathly Controls
n=10 Participants
Placebo, oral glucose tolerance test, and subcutaneous administration of recombinant human IGF-1 will be given at visits 2, 3, and 4 respectively. All visits will be performed within a 4 week period.
Oral Glucose Tolerance Test: Participants will have their blood drawn for a baseline value and then will be asked to drink a beverage with 75 grams of sugar. Blood will then be drawn every 30 minutes for 2 hours.
Subcutaneous administration of recombinant human IGF-1: Participants will receive a subcutaneous injection of recombinant human IGF-1 followed by a series of blood draws.
Placebo: Participants will receive a subcutaneous injection of saline followed by a series of blood draws.
|
|---|---|---|---|
|
Median Insulin Level in Response to Placebo, OGTT, and rhIGF1 Testing
Placebo
|
7 mU/L
Interval 3.0 to 16.0
|
9 mU/L
Interval 4.0 to 91.0
|
4 mU/L
Interval 0.5 to 6.0
|
|
Median Insulin Level in Response to Placebo, OGTT, and rhIGF1 Testing
OGTT
|
55 mU/L
Interval 6.0 to 395.0
|
39.5 mU/L
Interval 22.0 to 217.0
|
41.5 mU/L
Interval 11.0 to 124.0
|
|
Median Insulin Level in Response to Placebo, OGTT, and rhIGF1 Testing
IGF-1 suppression test
|
4 mU/L
Interval 0.5 to 13.0
|
4.5 mU/L
Interval 2.0 to 108.0
|
2.5 mU/L
Interval 0.5 to 9.0
|
SECONDARY outcome
Timeframe: Before injection at time 0 and then at 15, 30, 60, 90, 120, and 180 minutes after injection for week 2, 3, and 4 for each cohort for placebo, OGTT, and rhIGF1, respectively.Bioactive IGF-1 levels were measured at time 0 prior to the injection and measured at 15, 30, 60, 90, 120, and 180 minutes after injection. The area under the curve of bioactive IGF-1 was calculated for each subject and the medians calculated for each cohort during the placebo, OGTT, and rhIGF1 tests.
Outcome measures
| Measure |
Active Acromegaly
n=10 Participants
Placebo, oral glucose tolerance test, and subcutaneous administration of recombinant human IGF-1 will be given at visits 2, 3, and 4 respectively. All visits will be performed within a 4 week period.
Oral Glucose Tolerance Test: Participants will have their blood drawn for a baseline value and then will be asked to drink a beverage with 75 grams of sugar. Blood will then be drawn every 30 minutes for 2 hours.
Subcutaneous administration of recombinant human IGF-1: Participants will receive a subcutaneous injection of recombinant human IGF-1 followed by a series of blood draws.
Placebo: Participants will receive a subcutaneous injection of saline followed by a series of blood draws.
|
Type 2 Diabetes Mellitus(DM)
n=8 Participants
Placebo, oral glucose tolerance test, and subcutaneous administration of recombinant human IGF-1 will be given at visits 2, 3, and 4 respectively. All visits will be performed within a 4 week period.
Oral Glucose Tolerance Test: Participants will have their blood drawn for a baseline value and then will be asked to drink a beverage with 75 grams of sugar. Blood will then be drawn every 30 minutes for 2 hours.
Subcutaneous administration of recombinant human IGF-1: Participants will receive a subcutaneous injection of recombinant human IGF-1 followed by a series of blood draws.
Placebo: Participants will receive a subcutaneous injection of saline followed by a series of blood draws.
|
Heathly Controls
n=10 Participants
Placebo, oral glucose tolerance test, and subcutaneous administration of recombinant human IGF-1 will be given at visits 2, 3, and 4 respectively. All visits will be performed within a 4 week period.
Oral Glucose Tolerance Test: Participants will have their blood drawn for a baseline value and then will be asked to drink a beverage with 75 grams of sugar. Blood will then be drawn every 30 minutes for 2 hours.
Subcutaneous administration of recombinant human IGF-1: Participants will receive a subcutaneous injection of recombinant human IGF-1 followed by a series of blood draws.
Placebo: Participants will receive a subcutaneous injection of saline followed by a series of blood draws.
|
|---|---|---|---|
|
Median Bioactive IGF-1 Area Under the Curve in Response to Placebo, OGTT, and rhIGF1 Testing
Placebo
|
716 ng*min/mL
Interval 353.0 to 1154.0
|
291 ng*min/mL
Interval 127.0 to 842.0
|
302 ng*min/mL
Interval 138.0 to 902.0
|
|
Median Bioactive IGF-1 Area Under the Curve in Response to Placebo, OGTT, and rhIGF1 Testing
OGTT
|
699 ng*min/mL
Interval 379.0 to 1038.0
|
270 ng*min/mL
Interval 219.0 to 422.0
|
339 ng*min/mL
Interval 89.0 to 874.0
|
|
Median Bioactive IGF-1 Area Under the Curve in Response to Placebo, OGTT, and rhIGF1 Testing
IGF-1 suppression test
|
1004 ng*min/mL
Interval 853.0 to 1464.0
|
659 ng*min/mL
Interval 108.0 to 876.0
|
642 ng*min/mL
Interval 338.0 to 970.0
|
Adverse Events
Active Acromegaly
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Type 2 Diabetes Mellitus(DM)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Heathly Controls
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Active Acromegaly
n=10 participants at risk
Placebo, oral glucose tolerance test, and subcutaneous administration of recombinant human IGF-1 will be given at visits 2, 3, and 4 respectively. All visits will be performed within a 4 week period.
Oral Glucose Tolerance Test: Participants will have their blood drawn for a baseline value and then will be asked to drink a beverage with 75 grams of sugar. Blood will then be drawn every 30 minutes for 2 hours.
Subcutaneous administration of recombinant human IGF-1: Participants will receive a subcutaneous injection of recombinant human IGF-1 followed by a series of blood draws.
Placebo: Participants will receive a subcutaneous injection of saline followed by a series of blood draws.
|
Type 2 Diabetes Mellitus(DM)
n=8 participants at risk
Placebo, oral glucose tolerance test, and subcutaneous administration of recombinant human IGF-1 will be given at visits 2, 3, and 4 respectively. All visits will be performed within a 4 week period.
Oral Glucose Tolerance Test: Participants will have their blood drawn for a baseline value and then will be asked to drink a beverage with 75 grams of sugar. Blood will then be drawn every 30 minutes for 2 hours.
Subcutaneous administration of recombinant human IGF-1: Participants will receive a subcutaneous injection of recombinant human IGF-1 followed by a series of blood draws.
Placebo: Participants will receive a subcutaneous injection of saline followed by a series of blood draws.
|
Heathly Controls
n=10 participants at risk
Placebo, oral glucose tolerance test, and subcutaneous administration of recombinant human IGF-1 will be given at visits 2, 3, and 4 respectively. All visits will be performed within a 4 week period.
Oral Glucose Tolerance Test: Participants will have their blood drawn for a baseline value and then will be asked to drink a beverage with 75 grams of sugar. Blood will then be drawn every 30 minutes for 2 hours.
Subcutaneous administration of recombinant human IGF-1: Participants will receive a subcutaneous injection of recombinant human IGF-1 followed by a series of blood draws.
Placebo: Participants will receive a subcutaneous injection of saline followed by a series of blood draws.
|
|---|---|---|---|
|
Cardiac disorders
Low blood pressure
|
10.0%
1/10 • Number of events 1 • Adverse events were collected over the 4 weeks of the study period.
|
0.00%
0/8 • Adverse events were collected over the 4 weeks of the study period.
|
0.00%
0/10 • Adverse events were collected over the 4 weeks of the study period.
|
|
Skin and subcutaneous tissue disorders
Rash
|
10.0%
1/10 • Number of events 1 • Adverse events were collected over the 4 weeks of the study period.
|
0.00%
0/8 • Adverse events were collected over the 4 weeks of the study period.
|
0.00%
0/10 • Adverse events were collected over the 4 weeks of the study period.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place