Peripheral Metabolic Effects of Somatostatin

• Sponsor: University of Aarhus (Other)
• Overall Status: Completed
• CT.gov ID: NCT01062529
• Collaborator: The Ministry of Science, Technology and Innovation, Denmark (Other)
• Enrollment: 8
• Location: 1
• Arm: 1
• Duration (Months): 4
• Patients Per Site Per Month: 2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Acromegaly; Growth Hormone Deficiency; Diabetes	Drug: Somatostatin	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 8 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Single (Participant)
• Primary Purpose: Basic Science
• Official Title: Peripheral Metabolic Effects of Intra Arterial Somatostatin Infusion in Healthy Controls
• Study Start Date: Oct 1, 2009
• Actual Primary Completion Date: Feb 1, 2010
• Actual Study Completion Date: Feb 1, 2010

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Plasma levels of glucose [3 months]

Secondary Outcome Measures

1. GH signalling [one year]

2. Serum levels of free fatty acids (FFA) [one year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical department M	Aarhus		Denmark	8000

Sponsors and Collaborators

• University of Aarhus
• The Ministry of Science, Technology and Innovation, Denmark

Investigators

• Principal Investigator: Jens Otto L Jørgensen, Professor,

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Aarhus
• ClinicalTrials.gov Identifier: NCT01062529
• Other Study ID Numbers: M-2008005
• First Posted: Feb 4, 2010
• Last Update Posted: Jan 21, 2013
• Last Verified: Jan 1, 2013

• Keywords provided by University of Aarhus: GH signalling; insulin resistance; somatostatin; acromegaly
• Additional relevant MeSH terms: Acromegaly; Somatostatin

Study Results

No Results Posted as of Jan 21, 2013