Status:
UNKNOWN
Improving Insulin Sensitivity by Non-invasive Brain Stimulation in Persons With Insulin Resistance
Lead Sponsor:
University Hospital Tuebingen
Collaborating Sponsors:
German Center for Diabetes Research
Conditions:
Insulin Resistance
Transcranial Direct Current Stimulation
Eligibility:
All Genders
20-60 years
Phase:
NA
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 treatmen...
Detailed 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- Feasibility study: 1. Im...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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)
Key Trial Info
Start Date :
November 4 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2021
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04052399
Start Date
November 4 2019
End Date
December 31 2021
Last Update
May 14 2020
Active Locations (1)
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1
University Clinic Tübingen
Tübingen, Germany