Investigating the effect of transcranial direct current stimulation on appetite
- Conditions
- type 2 diabetic patients.Type 2 diabetes mellitus
- Registration Number
- IRCT20220305054185N1
- Lead Sponsor
- Esfahan University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 120
Previously diagnosed T2DM (HbA1C= 6.5% or FPG= 126 mg/dl or OGTT> 200 mg/dl)
Age > 18 years and < 65 years
BMI between 25-35 kg/m2
Food Craving Questionnaire-Trait (FCQ-T) > 30
Unwillingness or inability to complete any of the major aspects of the study protocol including food cue rating or behavioral assessments
Previously diagnosed psychiatric disorders (i.e., depression, psychotic disorders, personality disorders, dementia-related disorders)
Presence of eating disorders evaluated by Eating Disorder Examination Questionnaire
History of cancer, stroke, and renal, cardiovascular, or liver diseases
Use dietary supplements at the start of study or during last 3 months
Using appetite increasing or suppressing drugs
Any other condition the research team feel would put the subject at risk for entering the study
Contraindication to tDCS (pacemaker, a metal embedded in the scalp or brain, skin lesions at the site of stimulation, history of head injury or neurosurgery, and seizures)
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Food craving. Timepoint: Before intervention, day 14, day 30, day 60, day 90 after intervention. Method of measurement: Food Craving Questionnaire.
- Secondary Outcome Measures
Name Time Method Fasting plasma glucose. Timepoint: Before intervention, day 14, day 90 after intervention. Method of measurement: enzymatic UV-hexokinase.;Glycated hemoglobin A1C. Timepoint: Before intervention, day 14, day 90 after intervention. Method of measurement: high-performance liquid chromatography.;Serum Insulin. Timepoint: Before intervention, day 14, day 90 after intervention. Method of measurement: chemiluminescence microparticle immunoassay.;Weight. Timepoint: Before intervention, day 14, day 30, day 60, day 90 after intervention. Method of measurement: Scale.;Body composition. Timepoint: Before intervention, day 14, day 30, day 60, day 90 after intervention. Method of measurement: InBody 353 tetrapolar body composition analyzer.