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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 persons

Change 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 activity

Regional 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

Page last updated: August 23, 2015

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