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

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ClinicalTrials.gov Identifier: NCT01698944
Recruitment Status : Terminated (The trial was prematurely terminated due to low recruitment)
First Posted : October 3, 2012
Last Update Posted : February 27, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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).

Condition or disease Intervention/treatment Phase
Growth Hormone Disorder Adult Growth Hormone Deficiency Drug: somatropin Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cardiovascular Effects on Growth Hormone Replacement Therapy in Adults With Primary or Secondary Childhood Onset Growth Hormone Deficiency
Actual Study Start Date : May 16, 2001
Primary Completion Date : November 18, 2002
Study Completion Date : November 18, 2002


Arms and Interventions

Arm Intervention/treatment
Experimental: Somatropin Drug: somatropin
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


Outcome Measures

Primary Outcome Measures :
  1. Left Ventricular systolic function
  2. Left Ventricular diastolic function

Secondary Outcome Measures :
  1. Body composition
  2. Fasting glucose
  3. HbA1c (glycosylated haemoglobin)
  4. Oral glucose tolerance test (OGTT)

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01698944


Locations
Greece
Novo Nordisk Investigational Site
Athens, Greece, GR-11527
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
More Information

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01698944     History of Changes
Other Study ID Numbers: GHDADULT-1112
First Posted: October 3, 2012    Key Record Dates
Last Update Posted: February 27, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
Endocrine System Diseases
Dwarfism, Pituitary
Dwarfism
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Bone Diseases, Endocrine
Hypopituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs