Improving Insulin Sensitivity by Non-invasive Brain Stimulation in Persons With Insulin Resistance
1 other identifier
interventional
20
1 country
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. Insulin action in the brain is appreciated to play a vital role in the pathophysiology of T2D, influencing eating behavior, cognition and peripheral metabolism. Whether brain insulin resistance is a cause or consequence of prediabetes is not yet fully understood. Hence, in this project the investigators want to develop a novel tool to treat and prevent type 2 diabetes and to delineate brain mechanisms of insulin resistance in humans. For this purpose, transcranial direct current stimulation (tDCS) will be implemented, which is a powerful tool to stimulate brain networks. In recent studies, it was shown that the hypothalamus is 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2019
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 6, 2019
CompletedFirst Posted
Study publicly available on registry
August 9, 2019
CompletedStudy Start
First participant enrolled
November 4, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2021
CompletedMay 14, 2020
August 1, 2019
1.2 years
August 6, 2019
May 12, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
Caloric intake (kcal)
The investigators will assess 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
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, 10 min after tDCS and 10 min after breakfast
Secondary Outcomes (3)
Response inhibition
20 minutes during tDCS
Tastiness and healthiness rating of food stimuli
10 minutes task after breakfast
Food choice
10 minutes task after rating of food stimuli
Study Arms (3)
Anodal tDCS
ACTIVE COMPARATORAnodal tDCS of the lateral hypothalamus-cognitive or medial hypothalamus-cognitive network (2 conditions)
Cathodal tDCS
ACTIVE COMPARATORCathodal tDCS of the lateral hypothalamus-cognitive or medial hypothalamus-cognitive network (2 conditions)
Sham stimulation
PLACEBO COMPARATORSingle blind sham stimulation (ramp-up ramp-down stimulation will be applied for 30 seconds in order to simulate the active condition without any further continuous administration of current)
Interventions
Anodal tDCS of the lateral hypothalamus-cognitive or medial hypothalamus-cognitive network. The total injected current will never go beyond 4 milliamp, which will be split among the different stimulation electrodes.
Cathodal tDCS of the lateral hypothalamus-cognitive or medial hypothalamus-cognitive network. The total injected current will never go beyond 4 milliamp, which will be split among the different stimulation electrodes.
Single blind sham stimulation (ramp-up ramp-down stimulation will be applied for 30 seconds)
Eligibility Criteria
You may qualify if:
- Body mass index (BMI) between 25.5 and 35 kg/m2
- Age between 20 to 60 years of age
- Criteria for prediabetes:
- Fasting plasma glucose (PG) 100 mg/dL (5.6 mmol/L) to 125 mg/dL (6.9 mmol/L) (impaired fasting glucose) OR 2-h PG during 75-g oral glucose tolerance test 140 mg/dL (7.8 mmol/L) to 199 mg/dL (11.0 mmol/L) (impaired glucose tolerance) OR HbA1c 5.7-6.4% (39-47 mmol/mol)
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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital Tuebingenlead
- German Center for Diabetes Researchcollaborator
Study Sites (1)
University Clinic Tübingen
Tübingen, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stephanie Kullmann, PhD
University Hospital Tübingen
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 6, 2019
First Posted
August 9, 2019
Study Start
November 4, 2019
Primary Completion
December 31, 2020
Study Completion
December 31, 2021
Last Updated
May 14, 2020
Record last verified: 2019-08
Data Sharing
- IPD Sharing
- Will not share