Improving Insulin Sensitivity by Non-invasive Brain Stimulation

NCT04420650 | Completed

• 1 other identifier: BRAINSTIM
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (5)

• Performance during stop-signal task

  task is performed during 25-minutes tDCS stimulation

• Tastiness and healthiness rating of food stimuli

  task is performed immediatly after buffet

• Food choice

  task is performed immediatly after buffet

• Functional connectivity

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

• Diffusion-weighted imaging

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

Study Arms (3)

Anodal tDCS

ACTIVE COMPARATOR

Anodal tDCS of the hypothalamus-cognitive network

Device: transcranial direct current stimulation

Cathodal tDCS

ACTIVE COMPARATOR

Cathodal tDCS of the hypothalamus-cognitive network

Device: transcranial direct current stimulation

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)

Device: transcranial direct current stimulation

Interventions

transcranial direct current stimulation DEVICE

anodal or cathodal transcranial direct current stimulation

Anodal tDCS; Cathodal tDCS; Sham Stimulation

Eligibility Criteria

• Age: 20 Years - 66 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital Tuebingen: lead
• German Center for Diabetes Research: collaborator

Study Sites (1)

University Clinic Tübingen

Tübingen, 72076, Germany

Location

MeSH Terms

Conditions

Insulin Resistance; Obesity; Diabetes Mellitus

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Stephanie Kullmann, PhD

  Univeristy of Tübingen, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2020
• First Posted: June 9, 2020
• Study Start: May 26, 2020
• Primary Completion: October 31, 2023
• Study Completion: November 10, 2023
• Last Updated: November 14, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)