Improving Insulin Sensitivity by Non-invasive Brain Stimulation in Persons With Insulin Resistance

NCT04052399 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2020-05-14

No results posted yet for this study

Summary

Efforts in curing and preventing obesity and type 2 diabetes (T2D) have been elusive thus far. One reason for that is the lack of understanding of the role of the brain in the development and treatment of the disease. Insulin action in the brain is appreciated to play a vital role in the pathophysiology of T2D, influencing eating behavior, cognition and peripheral metabolism. Whether brain insulin resistance is a cause or consequence of prediabetes is not yet fully understood. Hence, in this project the investigators want to develop a novel tool to treat and prevent type 2 diabetes and to delineate brain mechanisms of insulin resistance in humans. For this purpose, transcranial direct current stimulation (tDCS) will be implemented, which is a powerful tool to stimulate brain networks. In recent studies, it was shown that the hypothalamus is part of a brain network including higher cognitive regions that is particularly vulnerable to insulin resistance. Furthermore, the central insulin response in this network predicted food craving and hunger. The investigators hypothesize that stimulating the hypothalamus-cognitive network will enhance insulin sensitivity and reduce food intake, food craving and hunger. Furthermore, the project will provide the unique opportunity to investigate novel mechanisms of insulin resistance in participants who have been extensively metabolically characterized.

Conditions

Interventions

DEVICE

anodal transcranial direct current stimulation

Anodal tDCS of the lateral hypothalamus-cognitive or medial hypothalamus-cognitive network. The total injected current will never go beyond 4 milliamp, which will be split among the different stimulation electrodes.

DEVICE

cathodal transcranial direct current stimulation

Cathodal tDCS of the lateral hypothalamus-cognitive or medial hypothalamus-cognitive network. The total injected current will never go beyond 4 milliamp, which will be split among the different stimulation electrodes.

DEVICE

transcranial direct current stimulation

Single blind sham stimulation (ramp-up ramp-down stimulation will be applied for 30 seconds)

Sponsors & Collaborators

  • German Center for Diabetes Research

    collaborator OTHER
  • University Hospital Tuebingen

    lead OTHER

Principal Investigators

  • Stephanie Kullmann, PhD · University Hospital Tübingen

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-11-04
Primary Completion
2020-12-31
Completion
2021-12-31

Countries

  • Germany

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04052399 on ClinicalTrials.gov