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Completed

NCT Number: NCT02468999

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

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.

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Key information

Conditions

Insulin Resistance Glucose Metabolism Disorders Hyperinsulinism Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University of Tuebingen, Department of Internal Medicine IV

Tübingen, 72076, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

human insulin

Drug

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital Tuebingen

Other

Registry information

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jun 11, 2015
Registry last updated
Jan 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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