Pupillography as Screening Tool for Brain Insulin Resistance

University Hospital Tuebingen

Status: Completed

Conditions: Obesity

Treatments: Diagnostic Test: Pupillography; Drug: placebo; Drug: human insulin

Study type: Interventional

Funder types: Other

Identifiers

NCT03651661

567/20168O2

Details and patient eligibility

About

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.

Enrollment: 22 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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22 participants in 2 patient groups, including a placebo group

nasal insulin

Active Comparator group

Description:

160 U of human insulin as nasal spray

Treatment:

Drug: human insulin

Diagnostic Test: Pupillography

nasal placebo

Placebo Comparator group

Description:

placebo as nasal spray

Treatment:

Drug: placebo

Diagnostic Test: Pupillography