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Peripheral Metabolic Effects of Somatostatin

Primary Purpose

Acromegaly, Growth Hormone Deficiency, Diabetes

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Somatostatin
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Acromegaly focused on measuring GH signalling, insulin resistance, somatostatin, acromegaly

Eligibility Criteria

18 Years - 50 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Medical department M

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

somatostatin

Arm Description

Outcomes

Primary Outcome Measures

Plasma levels of glucose

Secondary Outcome Measures

GH signalling
Serum levels of free fatty acids (FFA)

Full Information

First Posted
January 28, 2010
Last Updated
January 18, 2013
Sponsor
University of Aarhus
Collaborators
The Ministry of Science, Technology and Innovation, Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT01062529
Brief Title
Peripheral Metabolic Effects of Somatostatin
Official Title
Peripheral Metabolic Effects of Intra Arterial Somatostatin Infusion in Healthy Controls
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
February 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
Collaborators
The Ministry of Science, Technology and Innovation, Denmark

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acromegaly, Growth Hormone Deficiency, Diabetes
Keywords
GH signalling, insulin resistance, somatostatin, acromegaly

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
somatostatin
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Somatostatin
Intervention Description
4 h of 150 microgram infusion
Primary Outcome Measure Information:
Title
Plasma levels of glucose
Time Frame
3 months
Secondary Outcome Measure Information:
Title
GH signalling
Time Frame
one year
Title
Serum levels of free fatty acids (FFA)
Time Frame
one year

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jens Otto L Jørgensen, Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical department M
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark

12. IPD Sharing Statement

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Peripheral Metabolic Effects of Somatostatin

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