Improving Insulin Sensitivity by Non-invasive Brain Stimulation

Obesity Clinical Trial

Official title:

Improving Insulin Sensitivity by Non-invasive Brain Stimulation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04420650
• Other study ID #: BRAINSTIM
• Status: Completed
• Phase: N/A
• Start date: May 26, 2020
• Est. completion date: November 10, 2023

Study information

• Verified date: September 2023
• Source: University Hospital Tuebingen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: November 10, 2023
• Est. primary completion date: October 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 66 Years

Eligibility

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)

Related Conditions & MeSH terms

• Diabetes
• Insulin Resistance
• Magnetic Resonance Imaging
• Obesity
• Transcranial Direct Current Stimulation

Intervention

Device:
• transcranial direct current stimulation
anodal or cathodal transcranial direct current stimulation

Locations

Country	Name	City	State
Germany	University Clinic Tübingen	Tübingen

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Tuebingen	German Center for Diabetes Research

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peripheral insulin sensitivity	Oral glucose tolerance derived insulin sensitivity based on the Matsuda index	1 day after last intervention tDCS day
Primary	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
Primary	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
Secondary	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
Secondary	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.	task is performed immediatly after buffet
Secondary	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
Secondary	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
Secondary	Diffusion-weighted imaging	Diffusion weighted parameter based on MRI measurements	15 minutes MRI measurement performed before and after three day tDCS stimulation