Peripheral Metabolic Effects of Somatostatin

This study has been completed.
Sponsor:
Collaborator:
The Ministry of Science, Technology and Innovation, Denmark
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01062529
First received: January 28, 2010
Last updated: January 18, 2013
Last verified: January 2013
  Purpose

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 Intervention
Acromegaly
Growth Hormone Deficiency
Diabetes
Drug: Somatostatin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Official Title: Peripheral Metabolic Effects of Intra Arterial Somatostatin Infusion in Healthy Controls

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Plasma levels of glucose [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • GH signalling [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Serum levels of free fatty acids (FFA) [ Time Frame: one year ] [ Designated as safety issue: No ]

Enrollment: 8
Study Start Date: October 2009
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: somatostatin Drug: Somatostatin
4 h of 150 microgram infusion
Other Name: somatostatin

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01062529

Locations
Denmark
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
  More Information

No publications provided

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01062529     History of Changes
Other Study ID Numbers: M-2008005
Study First Received: January 28, 2010
Last Updated: January 18, 2013
Health Authority: Denmark: Ethics Committee

Keywords provided by University of Aarhus:
GH signalling
insulin resistance
somatostatin
acromegaly

Additional relevant MeSH terms:
Acromegaly
Dwarfism, Pituitary
Endocrine System Diseases
Bone Diseases, Endocrine
Bone Diseases
Musculoskeletal Diseases
Hyperpituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Dwarfism
Bone Diseases, Developmental
Hypopituitarism
Somatostatin
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 26, 2014