NCT00646815

Brief Summary

The purpose of this study is to further characterize the treatment related changes in insulin sensitivity, substrate metabolism and intrahepatic-intramyocellular lipids in patients with growth hormone deficiency (GHD).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2008

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 19, 2008

Completed
11 days until next milestone

Study Start

First participant enrolled

March 1, 2008

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 31, 2008

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

October 22, 2009

Status Verified

October 1, 2009

Enrollment Period

1.5 years

First QC Date

February 19, 2008

Last Update Submit

October 21, 2009

Conditions

Growth Hormone Deficiency

Keywords

insulin sensitivitysubstrate metabolismfatty liverintramyocellular lipidsgrowth hormone deficiencyGrowth hormone deficiency (Adult)

Outcome Measures

Primary Outcomes (1)

  • insulin sensitivity

    before and after 3 months treatment with growth hormone

Secondary Outcomes (3)

  • substrate metabolism

    before and after 3 months of growth hormone treatment

  • intrahepatic lipid content

    before and after 3 months of growth hormone treatment

  • intramyocellular lipid content

    before and after 3 months of growth hormone treatment

Study Arms (2)

a

EXPERIMENTAL

the aim of the present study is to characterize the treatment related changes in insulin sensitivity, substrate metabolism and intrahepatic-intramyocellular lipids in 12 adult patients, recently diagnosed with growth hormone deficiency

Drug: growth hormone (genotropin)

Control

NO INTERVENTION

Intramyocellular, intrahepatic and intraabdominal lipid content, lean body mass and body fat percentage, are assessed in ten healthy controls matched on age, gender and BMI.

Interventions

growth hormone (genotropin)DRUG

Dosage regulation will follow the local recommendations of GHD treatment

a

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Written informed consent
  • Must be of legal age and competent
  • Age: \>18 and \<60 years old

You may not qualify if:

  • Alcohol consumption \>21 units per week
  • Malignant disease
  • Pregnancy
  • Magnetic implants or material in the body
  • Claustrophobia
  • BMI \>30
  • Heart disease (NYHA \>2)
  • Uncontrolled hypertension
  • Manifest diabetes mellitus
  • Change in medication, with any influence on glucose metabolism, 2 months prior to and until the end of the trial.
  • Controls are matched on age, gender and BMI
  • Written informed consent
  • Must be of legal age and competent
  • Alcohol consumption \>21 units per week
  • Malignant disease
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Medical department M (Endocrinology and Diabetes), Aarhus University Hospital, Aarhus Sygehus, Denmark.

Aarhus, Aarhus, 8000, Denmark

Location

Medical Department M, Aarhus University Hospital

Aarhus, 8000, Denmark

Location

Related Links

MeSH Terms

Conditions

Dwarfism, PituitaryInsulin ResistanceFatty Liver

Interventions

Growth HormoneHuman Growth Hormone

Condition Hierarchy (Ancestors)

DwarfismBone Diseases, DevelopmentalBone DiseasesMusculoskeletal DiseasesBone Diseases, EndocrineHypopituitarismPituitary DiseasesHypothalamic DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesEndocrine System DiseasesHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Pituitary Hormones, AnteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Jens OL Jorgensen, Professor MD

    Medical Department M, Aarhus University Hospital, Aarhus, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 19, 2008

First Posted

March 31, 2008

Study Start

March 1, 2008

Primary Completion

September 1, 2009

Study Completion

September 1, 2009

Last Updated

October 22, 2009

Record last verified: 2009-10

Locations

DK(2)