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

Phase 4

Terminated

• Conditions: Adult Growth Hormone Deficiency; Growth Hormone Disorder
• Interventions: Drug: somatropin

• Registration Number: NCT01698944
• Lead Sponsor: Novo Nordisk A/S

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2001-05-16
• Primary Completion: 2002-11-18
• Study Completion: 2002-11-18
• Study First Submitted: 2012-10-01
• Study First Submitted QC: 2012-10-01
• Study First Posted: 2012-10-03
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-23
• Last Update Posted: 2017-02-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 7

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Somatropin	somatropin	-

Primary Outcome Measures

Name	Time	Method
Left Ventricular systolic function
Left Ventricular diastolic function

Secondary Outcome Measures

Name	Time	Method
Body composition
Oral glucose tolerance test (OGTT)
Fasting glucose
HbA1c (glycosylated haemoglobin)

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇬🇷 Athens, Greece