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Completed

NCT Number: NCT03651661

Pupillography as Screening Tool for Brain Insulin Resistance

Cerebral insulin action is important in the regulation of whole body glucose metabolism. However, the cerebral insulin action differs between individuals - there is a so called cerebral insulin resistance. The influence of central insulin action on peripheral metabolism seems at least partially mediated via the autonomous nervous system. A noninvasive method to measure autonomic function is the pupillography. The aim of the study is to find out whether pupillography can be used to assess central insulin activity. Thus, pupillography will be performed in 30 normal weight and 30 overweight subjects before and after application insulin intranasally.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

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

  • voluntary adults
  • HbA1c <5.8%
  • Age between 18 and 60 years
  • written consent

Exclusion criteria

  • There is a pregnancy or pregnancy can not be excluded
  • lactating women
  • Minors or non-consenting subjects are also excluded
  • Acute illness or infection within the last 4 weeks
  • Neurological and psychiatric disorders
  • intake of centrally acting drugs
  • Subjects with hemoglobin levels Hb <12g / dl (in females), Hb <14g / dl (males)
  • Allergic diseases against one of the substances used

Treatment and study plan

human insulin

Drug

human insulin administered as nasal spray

Placebo

Drug

placebo administered as nasal spray

Pupillography

Diagnostic Test

Autonomic tone will be adressed by pupillography using the F2D2 (Amtech Germany) device.

Primary outcomes

  1. Measurements of autonomic nervous system activity by pupillography

    Time frame: Measurements baseline and change to baseline 15 minutes and 30 minutes after spray application

    There will be measurements of autonomic nervous system activity by pupillography in order to identify central insulin action. The primary variable is the pupil width change in pupillography before compared to after intranasal insulin/placebo administration in 30 lean subjects. The investigation takes place in a darkened room with low backlight of about 5-10lx. The pupillographic recording is carried out with a commercially available device, F2D2 (Amtech Germany). In this case, the pupil width is recorded for 6 minutes continuously before and after nasal insulin (also 16 strokes of 10 E) or placebo doses with an infrared camera permanently mounted in a video goggle. Additionally, a possible change of the pupillary light reflection to monochromatic light is measured. Evaluation parameters are latency, amplitude and re-dilatation behavior.

  2. Measurements of latency of pupil response to light stimulation.

    Time frame: Measurements baseline and change to baseline 15 minutes and 30 minutes after spray application

    There will be measurements of autonomic nervous system activity by pupillography in order to identify central insulin action. The investigation takes place in a darkened room with low backlight of about 5-10lx. The pupillographic recording is carried out with a commercially available device, F2D2 (Amtech Germany). A possible change of the pupillary light reflection to monochromatic light is measured. Evaluation parameter is latency. The responses before and after nasal spray administration will be compared.

  3. Measurements of amplitude of pupil response to light stimulation.

    Time frame: Measurements baseline and change to baseline 15 minutes and 30 minutes after spray application

    There will be measurements of autonomic nervous system activity by pupillography in order to identify central insulin action. The investigation takes place in a darkened room with low backlight of about 5-10lx. The pupillographic recording is carried out with a commercially available device, F2D2 (Amtech Germany). A possible change of the pupillary light reflection to monochromatic light is measured. Evaluation parameter is amplitude . The responses before and after nasal spray administration will be compared.

  4. Measurements of re-dilation behaviour of pupil response to light stimulation.

    Time frame: Measurements baseline and change to baseline 15 minutes and 30 minutes after spray application

    There will be measurements of autonomic nervous system activity by pupillography in order to identify central insulin action. The investigation takes place in a darkened room with low backlight of about 5-10lx. The pupillographic recording is carried out with a commercially available device, F2D2 (Amtech Germany). A possible change of the pupillary light reflection to monochromatic light is measured. Evaluation parameter is re-dilatation behavior. The responses before and after nasal spray administration will be compared.

Secondary outcomes

  1. Autonomic nervous system

    Time frame: Measurements baseline and change to baseline 15 minutes and 30 minutes after spray application

    effect of nasal insulin or placebo spray on autonomic nervous system tone measured by heart rate variability.

Sponsors and collaborators

Lead sponsor

University Hospital Tuebingen

Other

Registry information

Official study title

Pupillographie Als Screeningtest für Cerebrale Insulinresistenz

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Aug 29, 2018
Registry last updated
Jan 10, 2019

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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