NCT01062529

Brief Summary

The aim of this study is to investigate peripheral effects of Somatostatin on glucose metabolism and growth hormone (GH) signalling in healthy men. Eight subjects will be enrolled. The hypothesis is that Somatostatin infusion reverses insulin resistance caused by GH.

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 Oct 2009

Shorter than P25 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 28, 2010

Completed
4 days 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
3 days until next milestone

First Posted

Study publicly available on registry

February 4, 2010

Completed
Last Updated

January 21, 2013

Status Verified

January 1, 2013

Enrollment Period

4 months

First QC Date

January 28, 2010

Last Update Submit

January 18, 2013

Conditions

AcromegalyGrowth Hormone DeficiencyDiabetes

Keywords

GH signallinginsulin resistancesomatostatinacromegaly

Outcome Measures

Primary Outcomes (1)

  • Plasma levels of glucose

    3 months

Secondary Outcomes (2)

  • GH signalling

    one year

  • Serum levels of free fatty acids (FFA)

    one year

Study Arms (1)

somatostatin

EXPERIMENTAL
Drug: Somatostatin

Interventions

SomatostatinDRUG

4 h of 150 microgram infusion

somatostatin

Eligibility Criteria

Age18 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • BMI \< 27 kg/m2
  • Written informed consent
  • Healthy

You may not qualify if:

  • Any disease
  • Any use of medications
  • Present or previous malignancy
  • Alcohol dependency
  • Allergy to trial medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical department M

Aarhus, Aarhus, 8000, Denmark

Location

MeSH Terms

Conditions

AcromegalyDwarfism, PituitaryDiabetes MellitusInsulin Resistance

Interventions

Somatostatin

Condition Hierarchy (Ancestors)

Bone Diseases, EndocrineBone DiseasesMusculoskeletal DiseasesHyperpituitarismPituitary DiseasesHypothalamic DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesEndocrine System DiseasesDwarfismBone Diseases, DevelopmentalHypopituitarismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesHyperinsulinism

Intervention Hierarchy (Ancestors)

Pituitary Hormone Release Inhibiting HormonesHypothalamic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPancreatic HormonesNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsNerve Tissue ProteinsProteins

Study Officials

  • Jens Otto L Jørgensen, Professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2010

First Posted

February 4, 2010

Study Start

October 1, 2009

Primary Completion

February 1, 2010

Study Completion

February 1, 2010

Last Updated

January 21, 2013

Record last verified: 2013-01

Locations

DK(1)