Peripheral Metabolic Effects of Somatostatin

Diabetes Clinical Trial

Official title:

Peripheral Metabolic Effects of Intra Arterial Somatostatin Infusion in Healthy Controls

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01062529
• Other study ID #: M-2008005
• Status: Completed
• Phase: N/A
• First received: January 28, 2010
• Last updated: January 18, 2013
• Start date: October 2009
• Est. completion date: February 2010

Study information

• Verified date: January 2013
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Acromegaly
• Diabetes
• Dwarfism, Pituitary
• Growth Hormone Deficiency

Intervention

Drug:
• Somatostatin
4 h of 150 microgram infusion

Locations

Country	Name	City	State
Denmark	Medical department M	Aarhus

Sponsors (2)

Lead Sponsor	Collaborator
University of Aarhus	The Ministry of Science, Technology and Innovation, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma levels of glucose		3 months	No
Secondary	GH signalling		one year	No
Secondary	Serum levels of free fatty acids (FFA)		one year	No