NCT00568568

Brief Summary

The purpose og this study is to investigate the effects of growth hormon on insulin signalling pathways and the temporal association between administration of GH and developing of insulin resistance.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2007

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2007

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

December 5, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 6, 2007

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
Last Updated

January 21, 2013

Status Verified

January 1, 2013

Enrollment Period

2.2 years

First QC Date

December 5, 2007

Last Update Submit

January 18, 2013

Conditions

Insulin Resistance

Keywords

Growth HormoneGH signalingInsulin resistanceInsulin Signaling

Outcome Measures

Primary Outcomes (1)

  • Socs 1-3 activity in muscle tissue and degree of insulin resistance

    6 hours

Secondary Outcomes (1)

  • Growth Hormone Signaling Proteins in Muscle Tissue and other Insulin Signaling Proteins in Muscle Tissue

    6 hours

Study Arms (1)

Growth hormone

EXPERIMENTAL
Drug: Growth hormone

Interventions

Growth hormoneDRUG

GH infusion from 8.00 pm to 03.00 am (dose 10,2 ng/kg/min) c) GH infusion from 02.00 am to 09.00 am (dose 10,2 ng/kg/min).

Also known as: Norditropin, Novo Nordisk
Growth hormone

Eligibility Criteria

Age18 Years - 65 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Written consent before study start
  • Growth Hormone substitution in stable dosis for at least 3 months prior to study start
  • Other substitution in stable dosis for at least 3 months prior to study start

You may not qualify if:

  • Medical treatment for diabetes
  • Hypertension even with medical treatment
  • BMI \> 30
  • Excessive alcohol abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department M (endocrinology and diabets)

Aarhus, Aarhus, 8000, Denmark

Location

MeSH Terms

Conditions

Insulin Resistance

Interventions

Growth HormoneHuman Growth Hormone

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Jens Otto L Jørgensen, MD, DMSc

    Depatment M (endocrinology and diabetes), Aarhus University Hospital, Nørrebrogade 44, 8000 Aarhus C, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 5, 2007

First Posted

December 6, 2007

Study Start

December 1, 2007

Primary Completion

February 1, 2010

Study Completion

February 1, 2010

Last Updated

January 21, 2013

Record last verified: 2013-01

Locations

DK(1)