Insulin ResistanceNCT04420650
Improving Insulin Sensitivity by Non-invasive Brain Stimulation
A study testing transcranial direct current stimulation in people with Insulin Resistance and Transcranial Direct Current Stimulation, run by University Hospital Tuebingen at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 66 yearsHealthy volunteers can take part
- Conditions the study is for
- Insulin Resistance, Transcranial Direct Current Stimulation, Obesity
- What is being tested?
- transcranial direct current stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteGermany
- Study dates
- 26 May 2020to 10 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 66 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Body mass index (BMI) between 25.5 and 39.5 kg/m2
- Age between 20 to 66 years of age
- Waist circumference ≥ 80 cm for women, ≥ 94 cm for men
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
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.
Read the 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
- Implement tDCS stimulation compared to sham stimulation in overweight and obese adults to assess the impact on eating behavior, cognition and metabolism.
- Evaluate whether 3-day non-invasive brain stimulation of the hypothalamus-cognitive network has a causal effect on metabolism.
- Evaluate whether 3-day non-invasive brain stimulation has a significant effect on brain functional connectivity and diffusion parameters.
- Conditions
- Insulin Resistance, Transcranial Direct Current Stimulation, Obesity, Diabetes, Magnetic Resonance Imaging
- Being tested
- transcranial direct current stimulation
- Medical subject headings
- Insulin Resistance, Obesity, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial direct current stimulationDevice
anodal or cathodal transcranial direct current stimulation
| Study group | Role | What they receive |
|---|---|---|
| Anodal tDCS | Active comparator | Anodal tDCS of the hypothalamus-cognitive network Receives: Device: transcranial direct current stimulation |
| Cathodal tDCS | Active comparator | Cathodal tDCS of the hypothalamus-cognitive network Receives: Device: transcranial direct current stimulation |
| Sham Stimulation | Sham comparator | Double blind sham stimulation (ramp-up ramp-down stimulation will be applied in order to simulate the active condition without any further continuous administration of current) Receives: Device: transcranial direct current stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peripheral insulin sensitivity
Oral glucose tolerance derived insulin sensitivity based on the Matsuda index
Measured: 1 day after last intervention tDCS day
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 directly after tDCS stimulation
Change in subjective feeling of hunger and food craving
On a visual analogue scale, subjective feeling of hunger and food craving will be assessed using a questionnaire.
Measured: 5 minutes before tDCS stimulation, 5 minutes after tDCS stimulation and 5 minutes after buffet
Secondary outcomes (5)
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 immediatly 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 heahlty].
Measured: task is performed immediatly after buffet
Functional connectivity
Resting-state functional connectivity of the hypothalamus-cognitive network is assessed by functional magnetic resonance imaging (fMRI)
Measured: 10 minutes functional MRI measurement performed before and after three day tDCS stimulation
Diffusion-weighted imaging
Diffusion weighted parameter based on MRI measurements
Measured: 15 minutes MRI measurement performed before and after three day tDCS stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start26 May 2020
- Primary completion31 Oct 2023
- Study completion10 Nov 2023
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.
- 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Collaborators
- German Center for Diabetes Research
- Responsible party
- Sponsor
- Investigators
- Stephanie Kullmann, PhD, Principal investigator, Univeristy of Tübingen, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04420650
- Sponsor's protocol ID
- BRAINSTIM
- Status last verified
- Sep 2023
- First submitted
- 26 May 2020
- Last updated
- 14 Nov 2023
- 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 14 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Insulin Sensitivity by Non-invasive Brain Stimulation
- ClinicalTrials.gov ID
- NCT04420650
- Acronym / sponsor ID
- BRAINSTIM
- Conditions
- Insulin Resistance, Transcranial Direct Current Stimulation, Obesity, Diabetes, Magnetic Resonance Imaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Collaborators
- German Center for Diabetes Research
- Study start
- 26 May 2020 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 10 Nov 2023 (actual)
- First posted
- 9 Jun 2020 (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.
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
- Implement tDCS stimulation compared to sham stimulation in overweight and obese adults to assess the impact on eating behavior, cognition and metabolism.
- Evaluate whether 3-day non-invasive brain stimulation of the hypothalamus-cognitive network has a causal effect on metabolism.
- Evaluate whether 3-day non-invasive brain stimulation has a significant effect on brain functional connectivity and diffusion parameters.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Anodal tDCS | Active comparator | Device: transcranial direct current stimulationAnodal tDCS of the hypothalamus-cognitive network |
| Cathodal tDCS | Active comparator | Device: transcranial direct current stimulationCathodal tDCS of the hypothalamus-cognitive network |
| Sham Stimulation | Sham comparator | Device: transcranial direct current stimulationDouble blind sham stimulation (ramp-up ramp-down stimulation will be applied in order to simulate the active condition without any further continuous administration of current) |
Who may qualify
- Ages
- 20 to 66 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Body mass index (BMI) between 25.5 and 39.5 kg/m2
- Age between 20 to 66 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 |
|---|---|---|
| transcranial direct current stimulationanodal or cathodal transcranial direct current stimulation | Device | Anodal tDCS, Cathodal tDCS, Sham Stimulation |
Primary outcome
Peripheral insulin sensitivity
Time frame: 1 day after last intervention tDCS day
Oral glucose tolerance derived insulin sensitivity based on the Matsuda index
Caloric intake (kcal)
Time frame: 1 hour directly after tDCS stimulation
Free-choice, ad libitum food intake from a standardized breakfast buffet. The caloric intake from fat, carbohydrates and protein will be documented.
Change in subjective feeling of hunger and food craving
Time frame: 5 minutes before tDCS stimulation, 5 minutes after tDCS stimulation and 5 minutes after buffet
On a visual analogue scale, subjective feeling of hunger and food craving will be assessed using a questionnaire.
5 secondary outcomes
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 immediatly after buffet
Food choice
Time frame: task is performed immediatly after buffet
Functional connectivity
Time frame: 10 minutes functional MRI measurement performed before and after three day tDCS stimulation
Diffusion-weighted imaging
Time frame: 15 minutes MRI measurement performed before and after three day tDCS stimulation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2023.
- 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.
Stephanie Kullmann, PhD principal investigator
Univeristy of Tübingen, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcranial direct current stimulation in people with Insulin Resistance and Transcranial Direct Current Stimulation, 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 3 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: finished, as of the sponsor's last update on 14 Nov 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Peripheral insulin sensitivity (time frame: 1 day after last intervention tDCS day). The study lists 3 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 14 Nov 2023.