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Completed

NCT Number: NCT02870361

Influence of Central Nervous Insulin Sensitivity on Insulin Secretion

Insulin resistance is a central pathophysiological component of type 2 diabetes and is associated with a high risk of cardiovascular disease. The tissue in which it manifests are mainly muscle, liver, and adipose tissue. Since the transport of glucose to the brain is independent of insulin, this organ has traditionally not been studied in this regard. In animal experiments, however, knockout of the insulin receptor in the brain leads to obesity and peripheral insulin resistance. This finding of insulin action in the brain could also be confirmed in human studies.

The investigators intend to investigate whether central nervous insulin action affects insulin secretion in humans. For this purpose, nasal insulin and placebo are administered 15 minutes before a hyperglycemic hyperinsulinemic clamps, which stimulate insulin secretion. Insulin sensitivity of the brain is measured by a an established protocol with functional magnetic resonance imaging before and after nasal insulin administration.

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Key information

Conditions

Insulin Secretion

Age range

18 year–50 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

  • HbA1c ≤6.0%
  • normal glucose tolerance during 75g oral glucose tolerance test (OGTT)

Exclusion criteria

  • Not removable metal parts in or on the body
  • manifest cardiovascular disease
  • claustrophobia
  • recent surgery (less than 3 months)
  • Simultaneous participation in other studies
  • Acute disease or infection within the last 4 weeks
  • neurological and psychiatric disorders
  • treatment with centrally acting drugs
  • hemoglobin Hb <13g / dl
  • Hypersensitivity to any of the substances used

Treatment and study plan

Intranasal insulin

Drug

Placebo

Drug

Primary outcomes

  1. Insulin secretion assessed as serum C-peptide levels during a hyperglycemic clamp

    Time frame: 0-10 min during hyperglycemic clamp and 10-90 min during hyperglycemic clamp

Secondary outcomes

  1. Correlation with brain insulin sensitivity

    Time frame: 15-30 minutes post insulin nasal spray

    Correlation of regional brain insulin sensitivity with the change of pancreatic insulin secretion due to central action of insulin. Changes in regional cerebral blood flow from before to after intranasal insulin administration will be assessed by functional magnetresonance imaging (fMRI)

  2. Differential effects in lean and overweight

    Time frame: 0-10 min during hyperglycemic clamp and 10-90 min during hyperglycemic clamp

    Differences in the effect of nasal insulin versus placebo on C-peptide levels during a hyperglycemic clamp between lean and overweight men will be assessed.

  3. Correlation with autonomous nervous system activity

    Time frame: 10 - 150 minutes post nasal spray

    Correlation of the change in pancreatic insulin secretion by central insulin action with the simultaneous change of the autonomous nervous system (measured by heart rate variability).

  4. Peripheral insulin sensitivity

    Time frame: 10-90 min and 70-90 min during hyperglycemic clamp

    Effect of nasal insulin versus placebo on peripheral insulin sensitivity assessed by hyperglycemic hyperinsulinemic clamp.

Sponsors and collaborators

Lead sponsor

University Hospital Tuebingen

Other

Registry information

Official study title

Einfluss Der zentralnervösen Insulinsensitivität Auf Die Insulinsekretion

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Aug 17, 2016
Registry last updated
May 8, 2018

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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