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
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
- Insulin Resistance
- Transcranial Direct Current Stimulation
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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