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Insulin Sensitivity of the Human CNS System: fMRI Study With Intranasal Insulin Application

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01797601
First Posted: February 22, 2013
Last Update Posted: December 3, 2015
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.
Information provided by (Responsible Party):
andreas fritsche, University Hospital Tuebingen
  Purpose
The purpose of the study is to investigate whether insulin sensitivity and insulin resistance of the human brain is comparable in all insulin sensitive parts of the brain and whether correlates to other phenotypic information (i.e. whole body insulin sensitivity, BMI, age) of the study participants.

Condition Intervention
Obesity Diabetes Drug: Human Insulin Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Insulinsensitivität Des Menschlichen Zentralnervensystems: Kernspintomographische Untersuchung Mit Intranasaler Gabe Von Insulin

Resource links provided by NLM:


Further study details as provided by andreas fritsche, University Hospital Tuebingen:

Primary Outcome Measures:
  • Insulin effect on regional brain activity assessed by fMRI [ Time Frame: Change from Baseline to 15 minutes and 60 minutes post spray application ]

Enrollment: 48
Study Start Date: February 2013
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Human Insulin
Nasal spray
Drug: Human Insulin
160 U of insulin
Placebo Comparator: Placebo solution
Nasal spray
Drug: Placebo
Insulin dilution medium without insulin

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Normal routine blood works
  • for women: negative pregnancy test
  • healthy

Exclusion Criteria:

  • Type 2 diabetes
  • pregnancy
  • acute or chronic diseases
  • Pacemakers
  • Artificial heart valves
  • Metal prostheses
  • Implanted magnetic metal parts (screws, ...)
  • Metal fragments
  • Braces
  • insulin pumps
  • Tattoos
  • claustrophobia
  • reduced temperature sensation and / or increased sensitivity to warming of the body
  • Ear disease or an increased sensitivity to loud noises
  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): NCT01797601


Locations
Germany
University of Tuebingen
Tuebingen, Germany, 72074
Sponsors and Collaborators
University Hospital Tuebingen
Investigators
Principal Investigator: Andreas Fritsche, MD Universität Tübingen
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: andreas fritsche, Prof. Andreas Fritsche, University Hospital Tuebingen
ClinicalTrials.gov Identifier: NCT01797601     History of Changes
Other Study ID Numbers: Eudra-CT: 2006-002244-29
17/2008AMG1 ( Other Identifier: Ethik-Kommission an der Medizinischen Fakultät der Eberhard-Karls-Universität und am Universitätsklinikum Tübingen )
First Submitted: February 18, 2013
First Posted: February 22, 2013
Last Update Posted: December 3, 2015
Last Verified: December 2015

Additional relevant MeSH terms:
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs