Pupillography as Screening Tool for Brain Insulin Resistance

NCT ID: NCT03651661

Last Updated: 2019-01-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-03

Study Completion Date

2019-01-07

Brief Summary

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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.

Detailed Description

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Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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nasal insulin

160 U of human insulin as nasal spray

Group Type ACTIVE_COMPARATOR

human insulin

Intervention Type DRUG

human insulin administered as nasal spray

Pupillography

Intervention Type DIAGNOSTIC_TEST

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

nasal placebo

placebo as nasal spray

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

placebo administered as nasal spray

Pupillography

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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human insulin

human insulin administered as nasal spray

Intervention Type DRUG

placebo

placebo administered as nasal spray

Intervention Type DRUG

Pupillography

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital Tuebingen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Tuebingen, Department of Internal Medicine IV

Tübingen, , Germany

Site Status

Countries

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Germany

Other Identifiers

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567/20168O2

Identifier Type: -

Identifier Source: org_study_id

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