Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05228067
Other study ID # 172/2021BO1
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date November 8, 2021
Est. completion date December 31, 2024

Study information

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

Clinical Trial Summary

Disturbances in the hypothalamus communication pathways with other regions in the brain and the periphery may represent a potential link between metabolic and cognitive health. The current project evaluates whether enhancing synaptic plasticity of this pathway can improve weight management, insulin sensitivity, and cognitive functions. In recent studies, we were able to show that the human brain is sensitive to insulin with favorable effects on peripheral metabolism and cognition. These brain regions encompass the hypothalamus and its connections to the striatum and prefrontal cortex. We want to investigate whether it is possible to enhance neuroplasticity of insulin-responsive brain regions to suppress the weight gain trajectory and improve dopamine-dependent cognitive functions in people with a high risk to develop type 2 diabetes. For this purpose, neuroimaging tools using high-definition transcranial direct current stimulation (HD-tDCS) and magnetic resonance imaging (MRI) will be implemented to assess synaptic plasticity of a neural network essential for metabolic and cognitive health.


Description:

The overarching aim of the study is to investigate the possibility to enhance neuroplasticity of the hypothalamus network to improve metabolism and dopamine-dependent cognitive functions. Specific objectives - Specifically, it is the first aim to study the predictive value of white matter microstructure (fiber tracts structurally connecting the target network) for tDCS-intervention response and to investigate tDCS-induced neuroplasticity changes of the hypothalamus brain network using functional magnetic resonance imaging (fMRI). - It is the second aim of this study to deepen our understanding of brain structure and function of the target network, which is known to rely on the neurotransmitter dopamine for its communication. Hence, we will use dopamine-dependent cognitive and eating behavior assessments. Participants will receive a thorough screening to obtain body composition by MRI, anthropometric measures, fasting glucose and insulin, indirect calorimetry, and general cognitive functions. Thereafter, participants will participate in three measurement days (separated by approx. one week) to receive a 25 min tDCS stimulation targeting the hypothalamus network in a double-blind cluster-randomized. Participant are randomized on three conditions: sham stimulation, anodal and cathodal stimulation. During the non-invasive brain stimulation, participants will perform a stop-signal task. On each measurement day, structural and functional MRI measurements are performed before and after stimulation. Dopamine-dependent behavior (i.e. reward task) will be assessed during fMRI measurement. Subsequently, participants will receive a breakfast buffet. The caloric intake from fat, carbohydrates and protein will be documented. Subjective feeling of hunger and food craving will be assessed using a visual analogue scale before stimulation, directly after stimulation and after breakfast. Food pictures will be rated on a laptop for taste and healthiness.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 40
Est. completion date December 31, 2024
Est. primary completion date November 30, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 65 Years
Eligibility Inclusion Criteria: - Written consent to participate in the study - Written consent to be informed about incidental findings Overweight and obese participants: - Body mass index (BMI) between 28 and 39.5 kg/m2 - Age between 20 to 65 years of age - Waist circumference > 80 cm for women, > 94 cm for men Sex and age matched normal weight individuals: - Body mass index (BMI) between 19.5 and 24.5 kg/m2 - Age between 20 to 65 years of age 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)

Study Design


Intervention

Device:
anodal transcranial direct current stimulation
anodal tDCS of the hypothalamus resting-state functional connectivity network using 12 Electrodes of the Starstim device by Neuroelectrics. The total injected current will never go beyond 4 milliamp, which will be split among the different stimulation electrodes.
cathodal transcranial direct current stimulation
anodal tDCS of the hypothalamus resting-state functional connectivity network using 12 Electrodes of the Starstim device by Neuroelectrics. The total injected current will never go beyond 4 milliamp, which will be split among the different stimulation electrodes.
sham transcranial direct current stimulation
Double blind sham stimulation of the hypothalamus resting-state functional connectivity network (ramp-up ramp-down stimulation will be applied for 30 seconds)

Locations

Country Name City State
Germany University Clinic Tübingen Tübingen

Sponsors (1)

Lead Sponsor Collaborator
University Hospital Tuebingen

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in neuroplasticity Fractional anisotropy (FA) of the target network 20 minutes directly before and after tDCS stimulation
Primary Change in functional connectivity Resting state functional connectivity of the target network 20 minutes directly before and after tDCS stimulation
Primary Change in eating behavior 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 after tDCS stimulation
Primary Change in dopamine-dependent cognitive function Changes in dopamine-dependent cognitive function and reward sensitivity measured by a reward-based decision-making task 20 minutes after tDCS stimulation
Secondary Change in subjective ratings Change in subjective ratings will be assessed using a visual analogue scale for hunger and subjective feeling of craving using a questionnaire (Food craving questionnaire). Visual analogue scale using a range from 0 to 10 cm, higher values indicating more hunger. Food craving questionnaire based on ordinal scale from 1 to 5, higher values indicating more food craving 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 immediately 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 healthy] task is performed immediately after buffet
See also
  Status Clinical Trial Phase
Recruiting NCT04243317 - Feasibility of a Sleep Improvement Intervention for Weight Loss and Its Maintenance in Sleep Impaired Obese Adults N/A
Recruiting NCT04101669 - EndoBarrier System Pivotal Trial(Rev E v2) N/A
Terminated NCT03772886 - Reducing Cesarean Delivery Rate in Obese Patients Using the Peanut Ball N/A
Completed NCT03640442 - Modified Ramped Position for Intubation of Obese Females. N/A
Completed NCT04506996 - Monday-Focused Tailored Rapid Interactive Mobile Messaging for Weight Management 2 N/A
Recruiting NCT06019832 - Analysis of Stem and Non-Stem Tibial Component N/A
Active, not recruiting NCT05891834 - Study of INV-202 in Patients With Obesity and Metabolic Syndrome Phase 2
Active, not recruiting NCT05275959 - Beijing (Peking)---Myopia and Obesity Comorbidity Intervention (BMOCI) N/A
Recruiting NCT04575194 - Study of the Cardiometabolic Effects of Obesity Pharmacotherapy Phase 4
Completed NCT04513769 - Nutritious Eating With Soul at Rare Variety Cafe N/A
Withdrawn NCT03042897 - Exercise and Diet Intervention in Promoting Weight Loss in Obese Patients With Stage I Endometrial Cancer N/A
Completed NCT03644524 - Heat Therapy and Cardiometabolic Health in Obese Women N/A
Recruiting NCT05917873 - Metabolic Effects of Four-week Lactate-ketone Ester Supplementation N/A
Active, not recruiting NCT04353258 - Research Intervention to Support Healthy Eating and Exercise N/A
Completed NCT04507867 - Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III N/A
Recruiting NCT03227575 - Effects of Brisk Walking and Regular Intensity Exercise Interventions on Glycemic Control N/A
Completed NCT01870947 - Assisted Exercise in Obese Endometrial Cancer Patients N/A
Recruiting NCT06007404 - Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents
Recruiting NCT05972564 - The Effect of SGLT2 Inhibition on Adipose Inflammation and Endothelial Function Phase 1/Phase 2
Recruiting NCT05371496 - Cardiac and Metabolic Effects of Semaglutide in Heart Failure With Preserved Ejection Fraction Phase 2