Pupillography as Screening Tool for Brain Insulin Resistance

Obesity Clinical Trial

Official title:

Pupillographie Als Screeningtest für Cerebrale Insulinresistenz

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03651661
• Other study ID #: 567/20168O2
• Status: Completed
• Phase: N/A
• Start date: July 3, 2018
• Est. completion date: January 7, 2019

Study information

• Verified date: July 2018
• Source: University Hospital Tuebingen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: January 7, 2019
• Est. primary completion date: November 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

Drug:
• human insulin
human insulin administered as nasal spray
• placebo
placebo administered as nasal spray

Diagnostic Test:
• Pupillography
Autonomic tone will be adressed by pupillography using the F2D2 (Amtech Germany) device.

Locations

Country	Name	City	State
Germany	University of Tuebingen, Department of Internal Medicine IV	Tübingen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Tuebingen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurements of autonomic nervous system activity by pupillography	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.	Measurements baseline and change to baseline 15 minutes and 30 minutes after spray application
Primary	Measurements of latency of pupil response to light stimulation.	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.	Measurements baseline and change to baseline 15 minutes and 30 minutes after spray application
Primary	Measurements of amplitude of pupil response to light stimulation.	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.	Measurements baseline and change to baseline 15 minutes and 30 minutes after spray application
Primary	Measurements of re-dilation behaviour of pupil response to light stimulation.	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.	Measurements baseline and change to baseline 15 minutes and 30 minutes after spray application
Secondary	Autonomic nervous system	effect of nasal insulin or placebo spray on autonomic nervous system tone measured by heart rate variability.	Measurements baseline and change to baseline 15 minutes and 30 minutes after spray application