- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04052399
Improving Insulin Sensitivity by Non-invasive Brain Stimulation in Persons With Insulin Resistance
Improving Insulin Sensitivity by Non-invasive Brain Stimulation- Feasibility Study
Study Overview
Status
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Stephanie Kullmann, PhD
- Phone Number: +49 7071 2987703
- Email: stephanie.kullmann@med.uni-tuebingen.de
Study Contact Backup
- Name: Martin Heni, MD
- Phone Number: +49 7071 2982711
- Email: martin.heni@med.uni-tuebingen.de
Study Locations
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-
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Tübingen, Germany
- Recruiting
- University clinic Tübingen
-
Contact:
- Stephanie Kullmann, PhD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
- 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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Anodal tDCS
Anodal tDCS of the lateral hypothalamus-cognitive or medial hypothalamus-cognitive network (2 conditions)
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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.
Other Names:
|
ACTIVE_COMPARATOR: Cathodal tDCS
Cathodal tDCS of the lateral hypothalamus-cognitive or medial hypothalamus-cognitive network (2 conditions)
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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.
Other Names:
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PLACEBO_COMPARATOR: Sham stimulation
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)
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Single blind sham stimulation (ramp-up ramp-down stimulation will be applied for 30 seconds)
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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1 hour after tDCS
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Change in subjective feeling of hunger and food craving
Time Frame: 5 minutes before tDCS, 10 min after tDCS and 10 min after breakfast
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On a visual analogue scale, subjective feeling of hunger and food craving will be assessed using a questionnaire.
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5 minutes before tDCS, 10 min after tDCS and 10 min after breakfast
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Response inhibition
Time Frame: 20 minutes during tDCS
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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.
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20 minutes during tDCS
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Tastiness and healthiness rating of food stimuli
Time Frame: 10 minutes task after breakfast
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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).
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10 minutes task after breakfast
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Food choice
Time Frame: 10 minutes task after rating of food stimuli
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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.
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10 minutes task after rating of food stimuli
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Stephanie Kullmann, PhD, University Hospital Tübingen
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 243/2019BO1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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