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NCT Number: NCT04420650

Improving Insulin Sensitivity by Non-invasive Brain Stimulation

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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Key information

Conditions

Insulin Resistance Body Weight Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Magnetic Resonance Imaging Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Transcranial Direct Current Stimulation

Age range

20 year–66 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Clinic Tübingen

Tübingen, 72076, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Transcranial Direct Current Stimulation

Device

anodal or cathodal transcranial direct current stimulation

Primary outcomes

  1. Peripheral insulin sensitivity

    Time frame: 1 day after last intervention tDCS day

    Oral glucose tolerance derived insulin sensitivity based on the Matsuda index

  2. 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.

  3. 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.

Secondary outcomes

  1. Performance during stop-signal task

    Time frame: task is performed during 25-minutes tDCS stimulation

    Outcome measures cover direction errors, proportion of successful stops, reaction time on Go trials, and stop signal reaction time (SSRT).

  2. Tastiness and healthiness rating of food stimuli

    Time frame: task is performed immediatly after buffet

    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.

  3. Food choice

    Time frame: task is performed immediatly after buffet

    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].

  4. Functional connectivity

    Time frame: 10 minutes functional MRI measurement performed before and after three day tDCS stimulation

    Resting-state functional connectivity of the hypothalamus-cognitive network is assessed by functional magnetic resonance imaging (fMRI)

  5. Diffusion-weighted imaging

    Time frame: 15 minutes MRI measurement performed before and after three day tDCS stimulation

    Diffusion weighted parameter based on MRI measurements

Sponsors and collaborators

Lead sponsor

University Hospital Tuebingen

Other

Collaborators

  • German Center for Diabetes Research

Registry information

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Jun 9, 2020
Registry last updated
Nov 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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