Influence of Central Nervous Insulin Action on Insulin Sensitivity of Peripheral Organs in Lean Versus Overweight Humans
Information source: University Hospital Tuebingen
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Insulin Resistance
Intervention: human insulin (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: University Hospital Tuebingen Official(s) and/or principal investigator(s): Andreas Fritsche, Prof. Dr., Principal Investigator, Affiliation: University Hospital Tuebingen
Overall contact: Andreas Fritsche, Prof. Dr., Phone: +49 7071 29 82714, Email: andreas.fritsche@med.uni-tuebingen.de
Summary
Research in animals and first experiments in humans indicate that insulin action in the
brain regulates peripheral insulin sensitivity. One major organ might be the liver. Previous
studies in humans showed that the human brain is an insulin sensitive organ in lean but not
in overweight/obese persons. Therefore, this study will include lean versus overweight/obese
persons.
In this study, insulin action will be introduced by intranasal insulin administration in
lean and overweight humans. As a control, placebo spray will be administered. To mimick the
known spill over of small amounts of intranasal insulin into circulation, a small bolus of
insulin will be administered over 15 minutes following placebo spray application.
Peripheral insulin sensitivity will be assessed by hyperinsulinemic-euglycemic glucose clamp
and glucose uptake and endogenous glucose production will be assessed by tracer dilution
technique. Autonomous nervous system activity will be addressed by heart rate variability.
Involved brain areas will be addressed by fMRI before and after nasal insulin application.
Clinical Details
Study design: Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science
Primary outcome: Change in glucose infusion rate during hyperinsulinemic euglycemic glucose clamp from before to after nasal spray application in lean personsChange in endogenous glucose production from before to after nasal spray application in lean persons Differences in insulin response between lean and overweight persons
Secondary outcome: Autonomous nervous system activityRegional brain insulin sensitivity
Eligibility
Minimum age: 18 Years.
Maximum age: 40 Years.
Gender(s): Male.
Criteria:
Inclusion Criteria:
- Male volunteers (lean or overweight/obese)
- HbA1c <6. 0%
- Age between 18 and 40 years
- healthy as assessed by physician
- Understanding the explanations about the study and instructions
Exclusion Criteria:
- non-removable metal parts in or on the body
- Persons with reduced temperature sensation and / or increased sensitivity to warming
of the body
- Cardiovascular disease can not be excluded, such as evident coronary heart disease,
congestive heart failure NYHA greater than 2, history of coronary artery disease
- History of stroke
- Persons with a hearing disorder or increased sensitivity to loud noises
- People with claustrophobia
- Subjects in which less than 3 months have passed since surgery
- Simultaneous participation in other studies
- Acute disease or infection within the last 4 weeks
- Neurological and psychiatric disorders
- Subjects with hemoglobin Hb <13g / dl
- Heparin-induced thrombocytopenia people with a (HIT) in prehistory
- Allergies to any of the used solutions/devices
Locations and Contacts
Andreas Fritsche, Prof. Dr., Phone: +49 7071 29 82714, Email: andreas.fritsche@med.uni-tuebingen.de
University of Tuebingen, Department of Internal Medicine IV, Tübingen 72076, Germany; Recruiting Andreas Fritsche, Prof. Dr., Phone: +49 7071 29 82714, Email: andreas.fritsche@med.uni-tuebingen.de Martin Heni, Dr., Phone: +49 7071 29 82714, Email: martin.heni@med.uni-tuebingen.de
Additional Information
Starting date: January 2015
Last updated: June 8, 2015
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