Insulin ResistanceNCT04052399
Improving Insulin Sensitivity by Non-invasive Brain Stimulation in Persons With Insulin Resistance
A study testing anodal transcranial direct current stimulation, cathodal transcranial direct current stimulation and 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 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Insulin Resistance, Transcranial Direct Current Stimulation
- What is being tested?
- anodal transcranial direct current stimulation, cathodal transcranial direct current stimulation and transcranial direct current stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- 4 Nov 2019to 31 Dec 2021
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body mass index (BMI) between 25.5 and 35 kg/m2
- Age between 20 to 60 years of age
- Criteria for prediabetes:
- Fasting plasma glucose (PG) 100 mg/dL (5.6 mmol/L) to 125 mg/dL (6.9 mmol/L) (impaired fasting glucose) OR 2-h PG during 75-g oral glucose tolerance test 140 mg/dL (7.8 mmol/L) to 199 mg/dL (11.0 mmol/L) (impaired glucose tolerance) OR HbA1c 5.7-6.4% (39-47 mmol/mol)
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
Show all 10Show fewer
- 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.
Germany1 site, 1 recruiting
- Recruiting
University Clinic Tübingen
Tübingen
Stephanie Kullmann, PhD
About this study
Official title: Improving Insulin Sensitivity by Non-invasive Brain Stimulation- Feasibility 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. 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.
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- Feasibility study:
- Implement resting-state functional magnetic resonance imaging to identify individual medial and lateral hypothalamic cognitive functional networks.
- Evaluate and test different non-invasive brain stimulation paradigms by tDCS to stimulate lateral and medial hypothalamus cognitive network on eating behavior and metabolism. 20 participants with overweight and obesity will receive five different tDCS stimulation protocols on five separate days (separated by one week) in a single-blind cluster-randomized order to reduce sequence effects. Optimal stimulation sites are assessed of the lateral and medial hypothalamus-cognitive network based on a modelling approach. Since this is the first study to stimulate the hypothalamus-cognitive network, excitatory as well as inhibitory stimulation is used. To reduce the number of conditions, participant are randomized based on the three main conditions: sham stimulation, anodal and cathodal stimulation. Medial hypothalamus-cognitive network versus lateral hypothalamus-cognitive network stimulation are pseudo-randomised. Participants will come in the morning, after an overnight fast, to receive a 20 min non-invasive brain stimulation, using tDCS. During the stimulation, participants will perform a stop-signal task on an tablet. 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.
- Being tested
- anodal transcranial direct current stimulation, cathodal transcranial direct current stimulation, transcranial direct current stimulation
- Medical subject headings
- Insulin Resistance
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
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.
cathodal transcranial direct current stimulationDevice
Also called cathodal tDCS
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.
transcranial direct current stimulationDevice
Also called tDCS
Single blind sham stimulation (ramp-up ramp-down stimulation will be applied for 30 seconds)
| Study group | Role | What they receive |
|---|---|---|
| Anodal tDCS | Active comparator | Anodal tDCS of the lateral hypothalamus-cognitive or medial hypothalamus-cognitive network (2 conditions) Receives: Device: anodal transcranial direct current stimulation |
| Cathodal tDCS | Active comparator | Cathodal tDCS of the lateral hypothalamus-cognitive or medial hypothalamus-cognitive network (2 conditions) Receives: Device: cathodal transcranial direct current stimulation |
| Sham stimulation | Placebo comparator | Single blind sham stimulation (ramp-up ramp-down stimulation will be applied for 30 seconds 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.
Caloric intake (kcal)
The investigators will assess 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
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, 10 min after tDCS and 10 min after breakfast
Secondary outcomes (3)
Response inhibition
To measure the performance during the stop-signal task (i.e. response inhibition) direction errors, proportion of successful stops, reaction time on Go trials, and stop signal reaction time (SSRT) will be measured.
Measured: 20 minutes during tDCS
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 (1=not at all tasty/very unhealthy, 2=not tasty/unhealthy, 5 very tasty/healthy).
Measured: 10 minutes task after breakfast
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.
Measured: 10 minutes task after rating of food stimuli
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2019
- Study start4 Nov 2019
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2021 (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.
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
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, University Hospital Tuebingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04052399
- Sponsor's protocol ID
- 243/2019BO1
- Status last verified
- Aug 2019
- First submitted
- 6 Aug 2019
- Last updated
- 14 May 2020
- 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 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Insulin Sensitivity by Non-invasive Brain Stimulation- Feasibility Study
- ClinicalTrials.gov ID
- NCT04052399
- Acronym / sponsor ID
- 243/2019BO1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Collaborators
- German Center for Diabetes Research
- Study start
- 4 Nov 2019 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 9 Aug 2019 (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. 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.
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- Feasibility study:
- Implement resting-state functional magnetic resonance imaging to identify individual medial and lateral hypothalamic cognitive functional networks.
- Evaluate and test different non-invasive brain stimulation paradigms by tDCS to stimulate lateral and medial hypothalamus cognitive network on eating behavior and metabolism. 20 participants with overweight and obesity will receive five different tDCS stimulation protocols on five separate days (separated by one week) in a single-blind cluster-randomized order to reduce sequence effects. Optimal stimulation sites are assessed of the lateral and medial hypothalamus-cognitive network based on a modelling approach. Since this is the first study to stimulate the hypothalamus-cognitive network, excitatory as well as inhibitory stimulation is used. To reduce the number of conditions, participant are randomized based on the three main conditions: sham stimulation, anodal and cathodal stimulation. Medial hypothalamus-cognitive network versus lateral hypothalamus-cognitive network stimulation are pseudo-randomised. Participants will come in the morning, after an overnight fast, to receive a 20 min non-invasive brain stimulation, using tDCS. During the stimulation, participants will perform a stop-signal task on an tablet. 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
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Anodal tDCS | Active comparator | Device: anodal transcranial direct current stimulationAnodal tDCS of the lateral hypothalamus-cognitive or medial hypothalamus-cognitive network (2 conditions) |
| Cathodal tDCS | Active comparator | Device: cathodal transcranial direct current stimulationCathodal tDCS of the lateral hypothalamus-cognitive or medial hypothalamus-cognitive network (2 conditions) |
| Sham stimulation | Placebo comparator | Device: transcranial direct current stimulationSingle blind sham stimulation (ramp-up ramp-down stimulation will be applied for 30 seconds in order to simulate the active condition without any further continuous administration of current) |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Body mass index (BMI) between 25.5 and 35 kg/m2
- Age between 20 to 60 years of age
- Criteria for prediabetes:
- Fasting plasma glucose (PG) 100 mg/dL (5.6 mmol/L) to 125 mg/dL (6.9 mmol/L) (impaired fasting glucose) OR 2-h PG during 75-g oral glucose tolerance test 140 mg/dL (7.8 mmol/L) to 199 mg/dL (11.0 mmol/L) (impaired glucose tolerance) OR HbA1c 5.7-6.4% (39-47 mmol/mol)
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 tDCSAnodal 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 | Anodal tDCS |
| cathodal transcranial direct current stimulationAlso: cathodal tDCSCathodal 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 tDCS |
| transcranial direct current stimulationAlso: tDCSSingle blind sham stimulation (ramp-up ramp-down stimulation will be applied for 30 seconds) | Device | Sham stimulation |
Primary outcome
Caloric intake (kcal)
Time frame: 1 hour after tDCS
The investigators will assess 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, 10 min after tDCS and 10 min after breakfast
On a visual analogue scale, subjective feeling of hunger and food craving will be assessed using a questionnaire.
3 secondary outcomes
Response inhibition
Time frame: 20 minutes during tDCS
Tastiness and healthiness rating of food stimuli
Time frame: 10 minutes task after breakfast
Food choice
Time frame: 10 minutes task after rating of food stimuli
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2020.
- Individual participant dataSharing planned: No
Related trials for Insulin Resistance
Not yet recruitingPhase 2
Effects of Meal Macronutrients on Postprandial Lipids
Nephrotic Syndrome, Lipodystrophy
RecruitingObservational study
Long-Term Follow-Up of Survivors of Pediatric Cushing Disease
Cushing Disease
Recruiting
Effects of Urolithin A Supplementation on Glucose Metabolism in Healthy Adults 55 >= Years Old: A Randomized Triple-Masked Controlled Clinical Trial
Healthy Volunteer
Recruiting
Multi-omics Dissection of Gut Microbiome Engraftment During FMT
Recurrent C. Difficile (rCDI), Ulcerative Colitis (UC)
RecruitingObservational study
Study of the Effect of Innate on the Inflammatory Response to Endotoxin
Asthma, Atherosclerosis
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
University Hospital Tuebingen
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, cathodal transcranial direct current stimulation and 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 4 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: status not confirmed, as of the sponsor's last update on 14 May 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stephanie Kullmann, PhD (+49 7071 2987703, stephanie.kullmann@med.uni-tuebingen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Caloric intake (kcal) (time frame: 1 hour after tDCS). The study lists 2 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 May 2020.