Trial Outcomes & Findings for Effects of Growth Hormone Administration on Cardiovascular Risk in Cured Acromegalics With Growth Hormone Deficiency (NCT NCT00182091)

Results Overview

Change in high-sensitivity C-reactive protein in the AcroGHD randomized to Growth Hormone and AcroGHD randomized to Placebo arms. Note that the AcroGHS and Active Acromegaly arms were not interventional arms and thus do not have outcome results.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

75 participants

Primary outcome timeframe

baseline and 6 months

Results posted on

2020-09-02

Participant Flow

Participant milestones

Participant milestones
Measure	AcroGHD Randomized to Growth Hormone Subjects with a history of acromegaly who are now growth hormone deficient, randomized to growth hormone. This is an interventional arm.	AcroGHD Randomized to Placebo Subjects with a history of acromegaly who are now growth hormone deficient, randomized to placebo. This is an interventional arm.	AcroGHS Subjects with a history of acromegaly who now have normal growth hormone levels. This is not an interventional arm.	Active Acromegaly Subjects with active acromegaly. This is not an interventional arm.
Overall Study STARTED	15	15	25	20
Overall Study COMPLETED	14	15	25	20
Overall Study NOT COMPLETED	1	0	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	AcroGHD Randomized to Growth Hormone Subjects with a history of acromegaly who are now growth hormone deficient, randomized to growth hormone. This is an interventional arm.	AcroGHD Randomized to Placebo Subjects with a history of acromegaly who are now growth hormone deficient, randomized to placebo. This is an interventional arm.	AcroGHS Subjects with a history of acromegaly who now have normal growth hormone levels. This is not an interventional arm.	Active Acromegaly Subjects with active acromegaly. This is not an interventional arm.
Overall Study Withdrawal by Subject	1	0	0	0

Baseline Characteristics

Effects of Growth Hormone Administration on Cardiovascular Risk in Cured Acromegalics With Growth Hormone Deficiency

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	AcroGHD Randomized to Growth Hormone n=15 Participants Subjects with a history of acromegaly who are now growth hormone deficient, randomized to growth hormone. This is an interventional arm.	AcroGHD Randomized to Placebo n=15 Participants Subjects with a history of acromegaly who are now growth hormone deficient, randomized to placebo. This is an interventional arm.	AcroGHS n=25 Participants Subjects with a history of acromegaly who now have normal growth hormone levels. This is not an interventional arm.	Active Acromegaly n=20 Participants Subjects with active acromegaly. This is not an interventional arm.	Total n=75 Participants Total of all reporting groups
Age, Continuous	47 years STANDARD_DEVIATION 12 • n=5 Participants	47 years STANDARD_DEVIATION 11 • n=7 Participants	47 years STANDARD_DEVIATION 12 • n=5 Participants	46 years STANDARD_DEVIATION 14 • n=4 Participants	46 years STANDARD_DEVIATION 12 • n=21 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	8 Participants n=7 Participants	18 Participants n=5 Participants	10 Participants n=4 Participants	45 Participants n=21 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	7 Participants n=7 Participants	7 Participants n=5 Participants	10 Participants n=4 Participants	30 Participants n=21 Participants

PRIMARY outcome

Timeframe: baseline and 6 months

Population: In the Growth Hormone group, 1 study participant did not complete the study due to discomfort at injection sites. In the Placebo group, data from one study participant was excluded from analysis due to initiation of appetite suppressants to induce weight loss during the study, as prescribed by a physician at a bariatric clinic.

Change in high-sensitivity C-reactive protein in the AcroGHD randomized to Growth Hormone and AcroGHD randomized to Placebo arms. Note that the AcroGHS and Active Acromegaly arms were not interventional arms and thus do not have outcome results.

Outcome measures

Outcome measures
Measure	AcroGHD Randomized to Growth Hormone n=14 Participants Subjects with a history of acromegaly who are now growth hormone deficient, randomized to growth hormone. This is an interventional arm.	AcroGHD Randomized to Placebo n=14 Participants Subjects with a history of acromegaly who are now growth hormone deficient, randomized to placebo. This is an interventional arm.
Change in High-sensitivity C-reactive Protein baseline	2.93 mg/liter Standard Deviation 3.32	3.23 mg/liter Standard Deviation 2.42
Change in High-sensitivity C-reactive Protein change at 6 months	-0.36 mg/liter Standard Deviation 1.52	1.64 mg/liter Standard Deviation 3.36

SECONDARY outcome

Timeframe: baseline and 6 months

Population: In the Growth Hormone group, 1 study participant did not complete the study due to discomfort at injection sites. In the Placebo group, data from one study participant was excluded from analysis due to initiation of appetite suppressants to induce weight loss during the study, as prescribed by a physician at a bariatric clinic.

Change in total fat mass in the AcroGHD randomized to Growth Hormone and AcroGHD randomized to Placebo arms. Note that the AcroGHS and Active Acromegaly arms were not interventional arms and thus do not have outcome results.

Outcome measures

Outcome measures
Measure	AcroGHD Randomized to Growth Hormone n=14 Participants Subjects with a history of acromegaly who are now growth hormone deficient, randomized to growth hormone. This is an interventional arm.	AcroGHD Randomized to Placebo n=14 Participants Subjects with a history of acromegaly who are now growth hormone deficient, randomized to placebo. This is an interventional arm.
Change in Total Fat Mass baseline	29.9 kilograms Standard Deviation 9.2	32.3 kilograms Standard Deviation 12.0
Change in Total Fat Mass change at 6 months	-1.6 kilograms Standard Deviation 3.2	0.7 kilograms Standard Deviation 2.2

SECONDARY outcome

Timeframe: baseline and 6 months

Population: In the Growth Hormone group, 1 study participant did not complete the study due to discomfort at injection sites. In the Placebo group, data from one study participant was excluded from analysis due to initiation of appetite suppressants to induce weight loss during the study, as prescribed by a physician at a bariatric clinic.

Change in total abdominal adipose tissue in the AcroGHD randomized to Growth Hormone and AcroGHD randomized to Placebo arms. Note that the AcroGHS and Active Acromegaly arms were not interventional arms and thus do not have outcome results.

Outcome measures

Outcome measures
Measure	AcroGHD Randomized to Growth Hormone n=14 Participants Subjects with a history of acromegaly who are now growth hormone deficient, randomized to growth hormone. This is an interventional arm.	AcroGHD Randomized to Placebo n=14 Participants Subjects with a history of acromegaly who are now growth hormone deficient, randomized to placebo. This is an interventional arm.
Change in Total Abdominal Adipose Tissue baseline	47654 millimeters squared Standard Deviation 12725	46949 millimeters squared Standard Deviation 16674
Change in Total Abdominal Adipose Tissue change at 6 months	-4434 millimeters squared Standard Deviation 7684	1164 millimeters squared Standard Deviation 4319

SECONDARY outcome

Timeframe: baseline and 6 months

Population: In the Growth Hormone group, 1 study participant did not complete the study due to discomfort at injection sites. In the Placebo group, data from one study participant was excluded from analysis due to initiation of appetite suppressants to induce weight loss during the study, as prescribed by a physician at a bariatric clinic.

Change in visceral abdominal adipose tissue in the AcroGHD randomized to Growth Hormone and AcroGHD randomized to Placebo arms. Note that the AcroGHS and Active Acromegaly arms were not interventional arms and thus do not have outcome results.

Outcome measures

Outcome measures
Measure	AcroGHD Randomized to Growth Hormone n=14 Participants Subjects with a history of acromegaly who are now growth hormone deficient, randomized to growth hormone. This is an interventional arm.	AcroGHD Randomized to Placebo n=14 Participants Subjects with a history of acromegaly who are now growth hormone deficient, randomized to placebo. This is an interventional arm.
Change in Visceral Abdominal Adipose Tissue baseline	14207 millimeters squared Standard Deviation 6730	19006 millimeters squared Standard Deviation 9922
Change in Visceral Abdominal Adipose Tissue change at 6 months	-2004 millimeters squared Standard Deviation 3515	540 millimeters squared Standard Deviation 2401

Adverse Events

AcroGHD Randomized to Growth Hormone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

AcroGHD Randomized to Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

AcroGHS

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Active Acromegaly

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

Dr. Anne Klibanski

Massachusetts General Hospital

Phone: 617-726-3870

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place