Insulin ResistanceSTIMNCT05228067
Enhancing Brain Health by TDCS in Persons with Overweight and Obesity
A study testing anodal transcranial direct current stimulation and cathodal transcranial direct current stimulation in people with Insulin Resistance and Obesity, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Insulin Resistance, Obesity, Diabetes Type 2
- What is being tested?
- anodal transcranial direct current stimulation and cathodal transcranial direct current stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- 8 Nov 2021to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Written consent to participate in the study
- Written consent to be informed about incidental findings
- Overweight and obese participants:
- Body mass index (BMI) between 28 and 39.5 kg/m2
- Age between 20 to 65 years of age
- Waist circumference > 80 cm for women, > 94 cm for men
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- Sex and age matched normal weight individuals:
- Body mass index (BMI) between 19.5 and 24.5 kg/m2
- Age between 20 to 65 years of age
Who cannot join
- Insufficient knowledge of the German language
- Persons who cannot legally give consent
- Pregnancy or lactation
- History of severe mental or somatic disorders including neurological diseases (incl. Epileptic seizures)
- Taking psychotropic drugs
- Previous bariatric surgery
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- Acute infection within the last 4 weeks
- Hemoglobin values less than 12g/dl for women, less than 14 g/dl for men
- Current participation in a lifestyle intervention study or a pharmaceutical study
- Contradictions to a MRI measurement (e.g. metal implants)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Enhancing Brain Health to Prevent Type 2 Diabetes
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.
Read the detailed description
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
- Specifically, it is the first aim to study the predictive value of white matter microstructure (fiber tracts structurally connecting the target network) for tDCS-intervention response and to investigate tDCS-induced neuroplasticity changes of the hypothalamus brain network using functional magnetic resonance imaging (fMRI).
- It is the second aim of this study to deepen our understanding of brain structure and function of the target network, which is known to rely on the neurotransmitter dopamine for its communication. Hence, we will use dopamine-dependent cognitive and eating behavior assessments.
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.
- Conditions
- Insulin Resistance, Obesity, Diabetes Type 2
- Being tested
- anodal transcranial direct current stimulation, cathodal transcranial direct current stimulation, sham transcranial direct current stimulation
- Keywords
- tDCS, MRI, hypothalamus, functional connectivity
- Medical subject headings
- Insulin Resistance, Obesity, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anodal transcranial direct current stimulationDevice
Also called 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.
cathodal transcranial direct current stimulationDevice
Also called cathodal tDCS, inhibitory 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.
sham transcranial direct current stimulationDevice
Also called sham tDCS
Double blind sham stimulation of the hypothalamus resting-state functional connectivity network (ramp-up ramp-down stimulation will be applied for 30 seconds)
| Study group | Role | What they receive |
|---|---|---|
| Anodal stimulation | Active comparator | Anodal tDCS of the hypothalamus network Receives: Device: anodal transcranial direct current stimulation |
| Cathodal stimulation | Active comparator | Cathodal tDCS of the hypothalamus network Receives: Device: cathodal transcranial direct current stimulation |
| Sham stimulation | Sham comparator | Sham tDCS of the hypothalamus network Receives: Device: sham transcranial direct current stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in neuroplasticity
Fractional anisotropy (FA) of the target network
Measured: 20 minutes directly before and after tDCS stimulation
Change in functional connectivity
Resting state functional connectivity of the target network
Measured: 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
Measured: 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
Measured: 20 minutes after tDCS stimulation
Secondary outcomes (4)
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
Measured: 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)
Measured: 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
Measured: 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]
Measured: task is performed immediately after buffet
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2022
- Study start8 Nov 2021
- Primary completion30 Dec 2024
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insulin ResistanceStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- All participants receive sham stimulation, anodal stimulation and cathodal stimulation in a pseudo-randomized order on three separate measurement days.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05228067
- Sponsor's protocol ID
- 172/2021BO1
- Acronym
- STIM
- Status last verified
- Mar 2025
- First submitted
- 12 Nov 2021
- Last updated
- 30 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Brain Health to Prevent Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT05228067
- Acronym / sponsor ID
- STIM / 172/2021BO1
- Conditions
- Insulin Resistance, Obesity, Diabetes Type 2
- Keywords
- tDCS, MRI, hypothalamus, functional connectivity
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- 8 Nov 2021 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 8 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
- Specifically, it is the first aim to study the predictive value of white matter microstructure (fiber tracts structurally connecting the target network) for tDCS-intervention response and to investigate tDCS-induced neuroplasticity changes of the hypothalamus brain network using functional magnetic resonance imaging (fMRI).
- It is the second aim of this study to deepen our understanding of brain structure and function of the target network, which is known to rely on the neurotransmitter dopamine for its communication. Hence, we will use dopamine-dependent cognitive and eating behavior assessments.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- All participants receive sham stimulation, anodal stimulation and cathodal stimulation in a pseudo-randomized order on three separate measurement days.
| Arm | Type | Receives |
|---|---|---|
| Anodal stimulation | Active comparator | Device: anodal transcranial direct current stimulationAnodal tDCS of the hypothalamus network |
| Cathodal stimulation | Active comparator | Device: cathodal transcranial direct current stimulationCathodal tDCS of the hypothalamus network |
| Sham stimulation | Sham comparator | Device: sham transcranial direct current stimulationSham tDCS of the hypothalamus network |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Written consent to participate in the study
- Written consent to be informed about incidental findings
- Body mass index (BMI) between 28 and 39.5 kg/m2
- Age between 20 to 65 years of age
- Waist circumference > 80 cm for women, > 94 cm for men
Key exclusion criteria (10 listed)
- Insufficient knowledge of the German language
- Persons who cannot legally give consent
- Pregnancy or lactation
- History of severe mental or somatic disorders including neurological diseases (incl. Epileptic seizures)
- Taking psychotropic drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| anodal transcranial direct current stimulationAlso: anodal tDCS, excitatory tDCSanodal 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. | Device | Anodal stimulation |
| cathodal transcranial direct current stimulationAlso: cathodal tDCS, inhibitory tDCSanodal 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. | Device | Cathodal stimulation |
| sham transcranial direct current stimulationAlso: sham tDCSDouble blind sham stimulation of the hypothalamus resting-state functional connectivity network (ramp-up ramp-down stimulation will be applied for 30 seconds) | Device | Sham stimulation |
Primary outcome
Change in neuroplasticity
Time frame: 20 minutes directly before and after tDCS stimulation
Fractional anisotropy (FA) of the target network
Change in functional connectivity
Time frame: 20 minutes directly before and after tDCS stimulation
Resting state functional connectivity of the target network
Change in eating behavior
Time frame: 1 hour after tDCS stimulation
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
Change in dopamine-dependent cognitive function
Time frame: 20 minutes after tDCS stimulation
Changes in dopamine-dependent cognitive function and reward sensitivity measured by a reward-based decision-making task
4 secondary outcomes
Change in subjective ratings
Time frame: 5 minutes before tDCS stimulation, 5 minutes after tDCS stimulation and 5 minutes after buffet
Performance during stop-signal task
Time frame: task is performed during 25-minutes tDCS stimulation
Tastiness and healthiness rating of food stimuli
Time frame: task is performed immediately after buffet
Food choice
Time frame: task is performed immediately after buffet
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing anodal transcranial direct current stimulation and cathodal transcranial direct current stimulation in people with Insulin Resistance and Obesity, run by University Hospital Tuebingen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in neuroplasticity (time frame: 20 minutes directly before and after tDCS stimulation). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2025.