Peripheral Metabolic Effects of Somatostatin

January 18, 2013 updated by: University of Aarhus

Peripheral Metabolic Effects of Intra Arterial Somatostatin Infusion in Healthy Controls

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus, Denmark, 8000
        • Medical Department M

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: somatostatin
Drug: Somatostatin
4 h of 150 microgram infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Plasma levels of glucose
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
GH signalling
Time Frame: one year
one year
Serum levels of free fatty acids (FFA)
Time Frame: one year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Collaborators

The Ministry of Science, Technology and Innovation, Denmark

Investigators

  • Principal Investigator: Jens Otto L Jørgensen, Professor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Actual)

February 1, 2010

Study Completion (Actual)

February 1, 2010

Study Registration Dates

First Submitted

January 28, 2010

First Submitted That Met QC Criteria

February 3, 2010

First Posted (Estimate)

February 4, 2010

Study Record Updates

Last Update Posted (Estimate)

January 21, 2013

Last Update Submitted That Met QC Criteria

January 18, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M-2008005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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