Trial Outcomes & Findings for Adult Growth Hormone Deficiency and Cardiovascular Risk (NCT NCT00720902)

NCT ID: NCT00720902

Last Updated: 2022-11-16

Results Overview

C-reactive protein (CRP) levels in GH sufficient and GH deficient participants

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 7 participants
• Primary outcome timeframe: Day 1
• Results posted on: 2022-11-16

Participant Flow

Participant milestones

Measure	Growth Hormone (GH) Sufficient Participants Participants with normal growth hormone secretion.	Growth Hormone (GH) Deficient Participants Participants with growth hormone secretion deficiency
Overall Study STARTED	4	3
Overall Study COMPLETED	0	3
Overall Study NOT COMPLETED	4	0

Reasons for withdrawal

Measure	Growth Hormone (GH) Sufficient Participants Participants with normal growth hormone secretion.	Growth Hormone (GH) Deficient Participants Participants with growth hormone secretion deficiency
Overall Study Withdrawal by Subject	1	0
Overall Study Unable to perform testing, lack of test agent and the Study terminated	3	0

Baseline Characteristics

Adult Growth Hormone Deficiency and Cardiovascular Risk

Baseline characteristics by cohort

Measure	GH Sufficient Participants n=4 Participants Participants with normal growth hormone secretion.	GH Deficient Participants n=3 Participants Participants with growth hormone secretion deficiency.	Total n=7 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
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 1

Population: Study was terminated early due to insufficient enrollment and lack of GHRH study medication to be administered. The medication became unavailable in the US after enrollment began, but before that testing could be performed. Without that testing, further classification of subjects as sufficient or deficient could not be performed and the remainder of the tests could not be done. Partial testing was only done on 3 GH deficient subjects and the results of this are reported.

C-reactive protein (CRP) levels in GH sufficient and GH deficient participants

Outcome measures

Measure	GH Sufficient Participants Participants with normal growth hormone secretion	GH Deficient Participants n=3 Participants Participants with growth hormone secretion deficiency
C-reactive Protein (CRP) Levels	—	14.46 ng/dL Standard Deviation 14.90

PRIMARY outcome

Timeframe: Day 1

Population: Study was terminated early due to insufficient enrollment and lack of GHRH study medication to be administered. The medication became unavailable in the US after enrollment began, but before that testing could be performed. Without that testing, further classification of subjects as sufficient or deficient could not be performed and the remainder of the tests could not be done. Partial testing was only done on 3 GH deficient subjects and the results of this are reported.

Homocytsteine levels in GH sufficient and GH deficient participants

Outcome measures

Measure	GH Sufficient Participants Participants with normal growth hormone secretion	GH Deficient Participants n=3 Participants Participants with growth hormone secretion deficiency
Homocysteine Level	—	8.04 micromol/L Standard Deviation 0.90

PRIMARY outcome

Timeframe: Day 1

Population: Study was terminated early due to insufficient enrollment and lack of GHRH study medication to be administered. The medication became unavailable in the US after enrollment began, but before that testing could be performed. Without that testing, further classification of subjects as sufficient or deficient could not be performed and the remainder of the tests could not be done. Partial testing was only done on 3 GH deficient subjects and the results of this are reported.

Total cholesterol levels in GH sufficient and GH deficient participants

Outcome measures

Measure	GH Sufficient Participants Participants with normal growth hormone secretion	GH Deficient Participants n=3 Participants Participants with growth hormone secretion deficiency
Total Cholesterol Level	—	271 mg/dL Standard Deviation 90.5

SECONDARY outcome

Timeframe: Day 1

Population: Study was terminated early due to insufficient enrollment and lack of GHRH study medication to be administered. The medication became unavailable in the US after enrollment began, but before that testing could be performed. Without that testing, further classification of subjects as sufficient or deficient could not be performed and the remainder of the tests could not be done. Partial testing was only done on 3 GH deficient subjects and the results of this are reported.

Percentage of total body fat and trunk fat as measured by DXA

Outcome measures

Measure	GH Sufficient Participants Participants with normal growth hormone secretion	GH Deficient Participants n=3 Participants Participants with growth hormone secretion deficiency
Percentage of Fat Measured by DXA DEXA Total body fat	—	42.33333333 Percent Standard Error 8.73
Percentage of Fat Measured by DXA DEXA Trunk fat	—	21 Percent Standard Error 3.60

SECONDARY outcome

Timeframe: Day 1

Population: Study was terminated early due to insufficient enrollment and lack of GHRH study medication to be administered. The medication became unavailable in the US after enrollment began, but before that testing could be performed. Without that testing, further classification of subjects as sufficient or deficient could not be performed and the remainder of the tests could not be done. Partial testing was only done on 3 GH deficient subjects and the results of this are reported.

Lean body mass as measured by DXA

Outcome measures

Measure	GH Sufficient Participants Participants with normal growth hormone secretion	GH Deficient Participants n=3 Participants Participants with growth hormone secretion deficiency
Lean Body Mass by DXA DEXA	—	46.67 kg Standard Error 2.89

SECONDARY outcome

Timeframe: Day 1

Population: Study was terminated early due to insufficient enrollment and lack of GHRH study medication to be administered. The medication became unavailable in the US after enrollment began, but before that testing could be performed. Without that testing, further classification of subjects as sufficient or deficient could not be performed and the remainder of the tests could not be done. Partial testing was only done on 3 GH deficient subjects and the results of this are reported.

Insulin sensitivity as assessed by fasting insulin levels

Outcome measures

Measure	GH Sufficient Participants Participants with normal growth hormone secretion	GH Deficient Participants n=3 Participants Participants with growth hormone secretion deficiency
Insulin Sensitivity as Assessed by Fasting Insulin Levels	—	35.5 mIU/L Standard Deviation 28.94

SECONDARY outcome

Timeframe: Day 1

Population: Study was terminated early due to insufficient enrollment and lack of GHRH study medication to be administered. The medication became unavailable in the US after enrollment began, but before that testing could be performed. Without that testing, further classification of subjects as sufficient or deficient could not be performed and the remainder of the tests could not be done. Partial testing was only done on 3 GH deficient subjects and the results of this are reported.

Glucose levels as assessed by an oral glucose tolerance test

Outcome measures

Measure	GH Sufficient Participants Participants with normal growth hormone secretion	GH Deficient Participants n=3 Participants Participants with growth hormone secretion deficiency
Glucose Levels as Assessed by an Oral Glucose Tolerance Test	—	91.33 mg/dL Standard Deviation 4.163

SECONDARY outcome

Timeframe: Day 1

Population: Study was terminated early due to insufficient enrollment and lack of GHRH study medication to be administered. The medication became unavailable in the US after enrollment began, but before that testing could be performed. Without that testing, further classification of participants as sufficient or deficient could not be performed and the remainder of the tests could not be done. As a result, data were not collected for GH sufficient or GH deficient participants for this outcome measure

Endothelial function as assessed by flow mediated dilatation and endothelial cell biopsy for measurement of inflammatory markers.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Year 1

Population: Study was terminated early due to insufficient enrollment and lack of GHRH study medication to be administered. The medication became unavailable in the US after enrollment began, but before that testing could be performed. Without that testing, further classification of participants as sufficient or deficient could not be performed and the remainder of the tests could not be done. As a result, data were not collected for GH sufficient and GH deficient participants.

Carotid intimal-medial thickness studies will be measured by ultrasound

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 1

Population: Study was terminated early due to insufficient enrollment and lack of GHRH study medication to be administered. The medication became unavailable in the US after enrollment began, but before that testing could be performed. Without that testing, further classification of subjects as sufficient or deficient could not be performed and the remainder of the tests could not be done. Partial testing was only done on 3 GH deficient subjects and the results of this are reported.

Intramyocellular lipid content using MRI and MR spectroscopy of the soleus muscle was performed.

Outcome measures

Measure	GH Sufficient Participants Participants with normal growth hormone secretion	GH Deficient Participants n=3 Participants Participants with growth hormone secretion deficiency
Intramyocellular Lipid Content Using MRI and MR Spectroscopy	—	0.011763 Percent water signal Standard Deviation 0.00159

SECONDARY outcome

Timeframe: Day 1

Population: Study was terminated early due to insufficient enrollment and lack of GHRH study medication to be administered. The medication became unavailable in the US after enrollment began, but before that testing could be performed. Without that testing, further classification of subjects as sufficient or deficient could not be performed and the remainder of the tests could not be done. Partial testing was only done on 3 GH deficient subjects and the results of this are reported.

Intrahepatic lipid (IHL) content using MRI and MR spectroscopy of the liver was performed.

Outcome measures

Measure	GH Sufficient Participants Participants with normal growth hormone secretion	GH Deficient Participants n=3 Participants Participants with growth hormone secretion deficiency
Intrahepatic Lipid Content Using MRI and MR Spectroscopy	—	9.97 Percent water signal Standard Deviation 7.17

Adverse Events

GH Sufficient Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

GH Deficient Participants

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

Pamela Freda, MD

Columbia University

Phone: 212-305-3725

Email: puf1@columbia.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place