An interventional study of anodal transcranial direct current stimulation and cathodal transcranial direct current stimulation in Insulin Resistance, Obesity and Diabetes Type 2, sponsored by University Hospital Tuebingen. Active, not recruiting at 1 site in Germany. Open to participants aged 20 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-30.
Sponsored by University Hospital Tuebingen · Not applicable, Interventional, and Basic science
Disturbances in the hypothalamus communication pathways with other regions in the brain and the periphery may represent a potential link between metabolic and cognitive health. The current project evaluates whether enhancing synaptic plasticity of this pathway can improve weight management, insulin sensitivity, and cognitive functions. In recent studies, we were able to show that the human brain is sensitive to insulin with favorable effects on peripheral metabolism and cognition. These brain regions encompass the hypothalamus and its connections to the striatum and prefrontal cortex. We want to investigate whether it is possible to enhance neuroplasticity of insulin-responsive brain regions to suppress the weight gain trajectory and improve dopamine-dependent cognitive functions in people with a high risk to develop type 2 diabetes. For this purpose, neuroimaging tools using high-definition transcranial direct current stimulation (HD-tDCS) and magnetic resonance imaging (MRI) will be implemented to assess synaptic plasticity of a neural network essential for metabolic and cognitive health.
The overarching aim of the study is to investigate the possibility to enhance neuroplasticity of the hypothalamus network to improve metabolism and dopamine-dependent cognitive functions.
Specific objectives
Participants will receive a thorough screening to obtain body composition by MRI, anthropometric measures, fasting glucose and insulin, indirect calorimetry, and general cognitive functions. Thereafter, participants will participate in three measurement days (separated by approx. one week) to receive a 25 min tDCS stimulation targeting the hypothalamus network in a double-blind cluster-randomized. Participant are randomized on three conditions: sham stimulation, anodal and cathodal stimulation. During the non-invasive brain stimulation, participants will perform a stop-signal task. On each measurement day, structural and functional MRI measurements are performed before and after stimulation. Dopamine-dependent behavior (i.e. reward task) will be assessed during fMRI measurement. Subsequently, participants will receive a breakfast buffet. The caloric intake from fat, carbohydrates and protein will be documented. Subjective feeling of hunger and food craving will be assessed using a visual analogue scale before stimulation, directly after stimulation and after breakfast. Food pictures will be rated on a laptop for taste and healthiness.
6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.
This study's planned enrollment of 40 is below the median of 78 across 4,878 interventional studies indexed under Obesity.
Browse Obesity studies →University Hospital Tuebingen is the lead sponsor of 476 studies on the registry; 104 are open to participants now.
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Overweight and obese participants:
Sex and age matched normal weight individuals:
Exclusion Criteria:
Anodal tDCS of the hypothalamus network
Device: anodal transcranial direct current stimulation
Cathodal tDCS of the hypothalamus network
Device: cathodal transcranial direct current stimulation
Sham tDCS of the hypothalamus network
Device: sham transcranial direct current stimulation
anodal tDCS of the hypothalamus resting-state functional connectivity network using 12 Electrodes of the Starstim device by Neuroelectrics. The total injected current will never go beyond 4 milliamp, which will be split among the different stimulation electrodes.
Also known as: anodal tDCS, excitatory tDCS
anodal tDCS of the hypothalamus resting-state functional connectivity network using 12 Electrodes of the Starstim device by Neuroelectrics. The total injected current will never go beyond 4 milliamp, which will be split among the different stimulation electrodes.
Also known as: cathodal tDCS, inhibitory tDCS
Double blind sham stimulation of the hypothalamus resting-state functional connectivity network (ramp-up ramp-down stimulation will be applied for 30 seconds)
Also known as: sham tDCS
Change in neuroplasticity
Fractional anisotropy (FA) of the target network
Time frame: 20 minutes directly before and after tDCS stimulation
Change in functional connectivity
Resting state functional connectivity of the target network
Time frame: 20 minutes directly before and after tDCS stimulation
Change in eating behavior
Caloric intake (kcal), Free-choice, ad libitum food intake from a standardized breakfast buffet. The caloric intake from fat, carbohydrates and protein will be documented
Time frame: 1 hour after tDCS stimulation
Change in dopamine-dependent cognitive function
Changes in dopamine-dependent cognitive function and reward sensitivity measured by a reward-based decision-making task
Time frame: 20 minutes after tDCS stimulation
Change in subjective ratings
Change in subjective ratings will be assessed using a visual analogue scale for hunger and subjective feeling of craving using a questionnaire (Food craving questionnaire). Visual analogue scale using a range from 0 to 10 cm, higher values indicating more hunger. Food craving questionnaire based on ordinal scale from 1 to 5, higher values indicating more food craving
Time frame: 5 minutes before tDCS stimulation, 5 minutes after tDCS stimulation and 5 minutes after buffet
Performance during stop-signal task
Outcome measures cover direction errors, proportion of successful stops, reaction time on Go trials, and stop signal reaction time (SSRT)
Time frame: task is performed during 25-minutes tDCS stimulation
Tastiness and healthiness rating of food stimuli
Using a computer based task, participants rate food pictures of low caloric and high caloric foods and snacks on a 5-point scale based on subjective tastiness and healthiness
Time frame: task is performed immediately after buffet
Food choice
Using a computer based task, participants have to choose food items they preferred to eat compared to a reference food on a 5-point choice scale. The reference (or "neutral") food item is individually determined based the health and taste rating \[Scale: 1= not tasty/ not healthy up to 5= very tasty/ very healthy\]
Time frame: task is performed immediately after buffet
Plan to share: No
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University Hospital Tuebingen