NCT03651661

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Jul 2018

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 2, 2018

Completed
1 day until next milestone

Study Start

First participant enrolled

July 3, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 29, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 7, 2019

Completed
Last Updated

January 10, 2019

Status Verified

July 1, 2018

Enrollment Period

4 months

First QC Date

July 2, 2018

Last Update Submit

January 9, 2019

Conditions

Obesity

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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 Outcomes (1)

  • Autonomic nervous system

    Measurements baseline and change to baseline 15 minutes and 30 minutes after spray application

Study Arms (2)

nasal insulin

ACTIVE COMPARATOR

160 U of human insulin as nasal spray

Drug: human insulinDiagnostic Test: Pupillography

nasal placebo

PLACEBO COMPARATOR

placebo as nasal spray

Drug: placeboDiagnostic Test: Pupillography

Interventions

human insulinDRUG

human insulin administered as nasal spray

nasal insulin
placeboDRUG

placebo administered as nasal spray

nasal placebo
PupillographyDIAGNOSTIC_TEST

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

nasal insulinnasal placebo

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Tuebingen, Department of Internal Medicine IV

Tübingen, 72076, Germany

Location

MeSH Terms

Conditions

Obesity

Interventions

Insulin

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ProinsulinInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 2, 2018

First Posted

August 29, 2018

Study Start

July 3, 2018

Primary Completion

November 1, 2018

Study Completion

January 7, 2019

Last Updated

January 10, 2019

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)