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IRCT20220305054185N1 IRCT 2024-01-14 Esfahan University of Medical Sciences Investigating the effect of transcranial direct current stimulation on appetite Investigating the effect of transcranial direct current stimulation (tDCS) and a standard hypocaloric diet on food craving, appetite sensation, and glycemic control in patients with type 2 diabetes 2024-02-20 anticipated 120 Complete https://irct.ir/trial/70740 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The method of randomization that will be used is block-randomization. The unit of randomization is individual participants. The randomization will be stratified according to gender. This means that the randomization process ensures an even distribution of male and female participants between the active tDCS and sham stimulation groups. The random sequence will be built in blocks of 8 numbers. Within each block, there will be a random allocation of participants to each of four groups while maintaining the stratification by gender. The randomization will be conducted using Random Allocation software version 2.0 . Allocation concealment (with an concealed envelope) is carried out to hiding the allocation sequence from those involved in enrolling participants and assigning them to different study groups. Only the clinician administering the tDCS will be aware of the randomization. N/A type 2 diabetic patients. Intervention 1: Intervention group: Transcranial direct stimulation for two weeks every other day with an intensity of 20 mA for 20 minutes in the F4 and F3 areas of the head without any dietary recommendation. Intervention 2: Intervention group: Transcranial direct stimulation for two weeks every other day with an intensity of 20 mA for 20 minutes in the F4 and F3 areas of the head along with calorie-restricted diet (500 kcal less than daily energy requirement calculated using Mifflin St. Joer equation and distribution of carbohydrate, protein, and fat will be 55, 15, and 30 percent of total energy intake). Intervention 3: Intervention group: Sham stimulation of the head along with calorie-restricted diet (500 kcal less than daily energy requirement calculated using Mifflin St. Joer equation and distribution of carbohydrate, protein, and fat will be 55, 15, and 30 percent of total energy intake) for two weeks. Intervention 4: Control group: Sham stimulation of the head for two weeks without any dietary recommendation. Yes - There is a plan to make this available What will be shared: All collected deidentified IPD will be available. When: Starting 6 months after publication To whom: only available for people working in academic institutions Conditions: No other criteria are required. Where to obtain: Applicants should contact Amirhossein Ramezani Ahmadi Tel: (+98)9120745664 Fax: (+98)31-33373733 Mailing address: Isfahan Endocrine and Metabolism Research Center, Isfahan University of Medical Sciences, Isfahan, Iran. Email: amir.h.r.ahmadi@gmail.com How to obtain: The applicant must first send his/her request by e-mail using his/her academic e-mail stating the reason and the data usage. After a maximum of 2 weeks, the answer will be given to the applicant. Comments:
public Amirhossein Ramezani Ahmadi
Khorram street
Isfahan Iran (Islamic Republic of) 8187698191 +98 31 3335 9933 amir.h.r.ahmadi@gmail.com Esfahan University of Medical Sciences scientific Amirhossein Ramezani Ahmadi
Khorram street
Isfahan Iran (Islamic Republic of) 8187698191 +98 31 3335 9933 amir.h.r.ahmadi@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) 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 18 years 65 years Both 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) E11 Type 2 diabetes mellitus Treatment - Devices Treatment - Devices Treatment - Devices Placebo Intervention group: Transcranial direct stimulation for two weeks every other day with an intensity of 20 mA for 20 minutes in the F4 and F3 areas of the head without any dietary recommendation Intervention group: Transcranial direct stimulation for two weeks every other day with an intensity of 20 mA for 20 minutes in the F4 and F3 areas of the head along with calorie-restricted diet (500 kcal less than daily energy requirement calculated using Mifflin St. Joer equation and distribution of carbohydrate, protein, and fat will be 55, 15, and 30 percent of total energy intake) Intervention group: Sham stimulation of the head along with calorie-restricted diet (500 kcal less than daily energy requirement calculated using Mifflin St. Joer equation and distribution of carbohydrate, protein, and fat will be 55, 15, and 30 percent of total energy intake) for two weeks Control group: Sham stimulation of the head for two weeks without any dietary recommendation Food craving. Timepoint: Before intervention, day 14, day 30, day 60, day 90 after intervention. Method of measurement: Food Craving Questionnaire. 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. Esfahan University of Medical Sciences Approved 2023-05-21 Ethics committee of Isfahan University of Medical Sciences Hezar jarib Isfahan Isfehan Iran (Islamic Republic of)