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Influence of Central Nervous Insulin Action on Insulin Sensitivity of Peripheral Organs in Lean Versus Overweight Humans

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ClinicalTrials.gov Identifier: NCT02468999
Recruitment Status : Completed
First Posted : June 11, 2015
Last Update Posted : January 8, 2016
Sponsor:
Information provided by (Responsible Party):
University Hospital Tuebingen

Brief 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.


Condition or disease Intervention/treatment Phase
Insulin Resistance Drug: human insulin Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Study Start Date : January 2015
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: insulin nasal spray
160 Units of human insulin as nasal spray
Drug: human insulin
Placebo Comparator: placebo nasal spray
Nasal spray containing placebo solution
Drug: human insulin



Primary Outcome Measures :
  1. Change in glucose infusion rate during hyperinsulinemic euglycemic glucose clamp from before to after nasal spray application in lean persons [ Time Frame: Change from 70-90 min (before spray) to 170-210 min and to 280-300 min ]
  2. Change in endogenous glucose production from before to after nasal spray application in lean persons [ Time Frame: Change from 70-90 min (before spray) to 170-210 min and to 280-300 min ]
    Will be assessed by tracer dilution technique.

  3. Differences in insulin response between lean and overweight persons [ Time Frame: up to 210 minutes post nasal spray administration ]
    Will be assessed as plasma insulin and C-peptide concentrations.


Secondary Outcome Measures :
  1. Autonomous nervous system activity [ Time Frame: baseline, 70-90 min, 170-210 min and 280-300 min ]
    Will be assessed by analysis of heart rate variability.

  2. Regional brain insulin sensitivity [ Time Frame: 30 min ]
    Will be assessed on an additional study day by fMRI before and after intranasal insulin administration



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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

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): NCT02468999


Locations
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Germany
University of Tuebingen, Department of Internal Medicine IV
Tübingen, Germany, 72076
Sponsors and Collaborators
University Hospital Tuebingen
Investigators
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Principal Investigator: Andreas Fritsche, Prof. Dr. University Hospital Tuebingen
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Hospital Tuebingen
ClinicalTrials.gov Identifier: NCT02468999    
Other Study ID Numbers: 402/2014B01
First Posted: June 11, 2015    Key Record Dates
Last Update Posted: January 8, 2016
Last Verified: January 2016
Keywords provided by University Hospital Tuebingen:
Intranasal insulin
Additional relevant MeSH terms:
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Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Insulin
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs