Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| German Center for Diabetes Research | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
Objectives The overarching aim of the study is to stimulate the hypothalamus-cognitive brain network to improve insulin sensitivity and eating behavior.
Specific Objectives
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anodal tDCS | Active Comparator | Anodal tDCS of the hypothalamus-cognitive network |
|
| Cathodal tDCS | Active Comparator | Cathodal tDCS of the hypothalamus-cognitive network |
|
| 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| transcranial direct current stimulation | Device | anodal or cathodal transcranial direct current stimulation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Peripheral insulin sensitivity | Oral glucose tolerance derived insulin sensitivity based on the Matsuda index | 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. | 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. | 5 minutes before tDCS stimulation, 5 minutes after tDCS stimulation and 5 minutes after buffet |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | task is performed during 25-minutes tDCS stimulation |
| Tastiness and healthiness rating of food stimuli |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Stephanie Kullmann, PhD | Univeristy of Tübingen, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Clinic Tübingen | Tübingen | 72076 | Germany |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D009765 | Obesity |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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. |
| 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]. | 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) | 10 minutes functional MRI measurement performed before and after three day tDCS stimulation |
| Diffusion-weighted imaging | Diffusion weighted parameter based on MRI measurements | 15 minutes MRI measurement performed before and after three day tDCS stimulation |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004700 | Endocrine System Diseases |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |