Cardiovascular Effects on Growth Hormone Therapy in Adults With Growth Hormone Deficiency

Cardiovascular Effects on Growth Hormone Replacement Therapy in Adults With Primary or Secondary Childhood Onset Growth Hormone Deficiency

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01698944

Enrollment

Registered

2012-10-03

Start date

2001-05-16

Completion date

2002-11-18

Last updated

2017-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adult Growth Hormone Deficiency, Growth Hormone Disorder

Brief summary

This trial is conducted in Europe. The aim of this trial is to investigate the effect of growth hormone on left ventricle morphology and function (systolic and diastolic).

Interventions

DRUGsomatropin

Initial dose 0.5 IU/day and escalated up to maximum dose the first 6 months. Maximum dose 3.0 IU/day for 18 months. Injected subcutaneously (s.c., under the skin) daily

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

12 Years to 25 Years

Healthy volunteers

Inclusion criteria

* Adult growth hormone deficiency * At least 2 years without growth hormone treatment

Exclusion criteria

* Supine blood pressure above 160 mmHg systolic or above 100 mmHg diastolic * Pregnancy

Design outcomes

Primary

Measure	Time frame
Left Ventricular systolic function	—
Left Ventricular diastolic function	—

Secondary

Measure	Time frame
Body composition	—
Fasting glucose	—
HbA1c (glycosylated haemoglobin)	—
Oral glucose tolerance test (OGTT)	—

Countries

Greece

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026