Clinical Trials Directory

Trials / Completed

CompletedNCT04420650

Improving Insulin Sensitivity by Non-invasive Brain Stimulation

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
44 (actual)
Sponsor
University Hospital Tuebingen · Academic / Other
Sex
All
Age
20 Years – 66 Years
Healthy volunteers
Accepted

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. In recent studies, the hypothalamus was identified as 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. In this project, transcranial direct current stimulation (tDCS) is implemented as a tool to stimulate brain networks. 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.

Detailed description

Objectives The overarching aim of the study is to stimulate the hypothalamus-cognitive brain network to improve insulin sensitivity and eating behavior. Specific Objectives 1. Implement tDCS stimulation compared to sham stimulation in overweight and obese adults to assess the impact on eating behavior, cognition and metabolism. 2. Evaluate whether 3-day non-invasive brain stimulation of the hypothalamus-cognitive network has a causal effect on metabolism. 3. Evaluate whether 3-day non-invasive brain stimulation has a significant effect on brain functional connectivity and diffusion parameters.

Conditions

Interventions

TypeNameDescription
DEVICEtranscranial direct current stimulationanodal or cathodal transcranial direct current stimulation

Timeline

Start date
2020-05-26
Primary completion
2023-10-31
Completion
2023-11-10
First posted
2020-06-09
Last updated
2023-11-14

Locations

1 site across 1 country: Germany

Source: ClinicalTrials.gov record NCT04420650. Inclusion in this directory is not an endorsement.