Improving Insulin Sensitivity by Non-invasive Brain Stimulation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-26

Study Completion Date

2023-11-10

Brief Summary

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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.

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Detailed Description

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Objectives The overarching aim of the study is to stimulate the hypothalamus-cognitive brain network to improve insulin sensitivity and eating behavior.

Specific Objectives

1. Implement tDCS stimulation compared to sham stimulation in overweight and obese adults to assess the impact on eating behavior, cognition and metabolism.
2. Evaluate whether 3-day non-invasive brain stimulation of the hypothalamus-cognitive network has a causal effect on metabolism.
3. Evaluate whether 3-day non-invasive brain stimulation has a significant effect on brain functional connectivity and diffusion parameters.

Conditions

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Insulin Resistance Transcranial Direct Current Stimulation Obesity Diabetes Magnetic Resonance Imaging

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Anodal tDCS

Anodal tDCS of the hypothalamus-cognitive network

Group Type ACTIVE_COMPARATOR

transcranial direct current stimulation

Intervention Type DEVICE

anodal or cathodal transcranial direct current stimulation

Cathodal tDCS

Cathodal tDCS of the hypothalamus-cognitive network

Group Type ACTIVE_COMPARATOR

transcranial direct current stimulation

Intervention Type DEVICE

anodal or cathodal transcranial direct current stimulation

Sham Stimulation

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)

Group Type SHAM_COMPARATOR

transcranial direct current stimulation

Intervention Type DEVICE

anodal or cathodal transcranial direct current stimulation

Interventions

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transcranial direct current stimulation

anodal or cathodal transcranial direct current stimulation

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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

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)

Minimum Eligible Age

20 Years

Maximum Eligible Age

66 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes