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Peripheral Metabolic Effects of Somatostatin

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01062529
First Posted: February 4, 2010
Last Update Posted: January 21, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
The Ministry of Science, Technology and Innovation, Denmark
Information provided by (Responsible Party):
University of Aarhus
  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
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

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 ]

Secondary Outcome Measures:
  • GH signalling [ Time Frame: one year ]
  • Serum levels of free fatty acids (FFA) [ Time Frame: one year ]

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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01062529     History of Changes
Other Study ID Numbers: M-2008005
First Submitted: January 28, 2010
First Posted: February 4, 2010
Last Update Posted: January 21, 2013
Last Verified: January 2013

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

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