Effects of Transcranial Direct Current Stimulation on Glucose Level
NCT Number: NCT06479590
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Glucose Metabolism Disorders
Interventions: DEVICE: tDCS|OTHER: Sham tDCS
Sponsor: Riphah International University
Sex: ALL
Age: ADULT
Enrollment: 36
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-01
Completion Date: 2025-01-31
Locations: Pakistan Railway General Hospital, Rawalpindi, Punjab, Pakistan

Summary:
Previous studies have investigated the impact of tDCS on systemic glucose, neglecting to explore its effects on diabetic factors and its safety. Some studies used small sample size, limiting the ability to identify significant impacts or generalized findings to large population.

Primary Outcome Measures: RBS, Two hours after meal, peripheral venous blood samples are collected to check random blood glucose levels. The morning random glucose level had a linear relationship with glycated haemoglobin levels taken simultaneously. A blood glucose level of 7 mmol/l had 92.7% sensitivity for good control (HbA1c \< or = 7.8%) on a blood sample which was taken simultaneouslyand59.8% specific for the same, 2-4 hours|6 Minute walk test, The 6-minute walk test (6MWT) is widely employed in clinical settings due to its ease of administration, good tolerance, and safety. It assesses functional exercise capacity by measuring the distance an individual walks in 6 minutes. Moreover, it serves as a valuable predictor of morbidity and mortality across various cardiopulmonary conditions, demonstrating excellent reliability (ICC = 0.9) and validity in healthy adults., baseline
Secondary Outcome Measures: International physical activity questionnaire (IPAQ-SF), This cost-effective measure will assess participants' physical activity intensity and sitting time to estimate total physical activity in MET-min/week. It records activity levels across four categories: vigorous-intensity (e.g., aerobics), moderate-intensity (e.g., leisure cycling), walking, and sitting. The International Physical Activity Questionnaire Short Form(IPAQ-SF)demonstrates good test-retest reliability (ICC \> 0.65) and satisfactory criterionvalidity in healthy adults, baseline|Rapid Assessment of Physical Activity (RAPA), RAPA is a self-administered questionnaire comprising 9 items with yes or no responses, determining the level of physical activity. The first 7 items assess aerobic activity (RAPA 1), while the last 2 items focus on strength and flexibility(RAPA 2) and are not included in the total score. Test-retest reliability for RAPA in healthy adults is high, with a calculated value of 0.996 (95%CI0.992-0.998), indicating very good reliability, baseline|Finish Diabetes Risk Score, The Finnish Diabetes Risk Score (FINDRISC) questionnaire is a validated tool for predicting type 2 diabetes risk. It estimates the probability of developing diabetes within the next 10 years. FINDRISC demonstrates excellent reliability, with an Intra class Correlation Coefficient (ICC) of 0.94., baseline|GAD-7, The 7-item Generalized Anxiety Disorder Scale (GAD-7) is a self report tool for assessing symptoms of GAD, including excessive and uncontrollable anxiety and worry lasting at least 6 months. The scale demonstrates excellent reliability in young adults, with a cronbach'sαcoefficient of 0.895, surpassing the recommended threshold of 0.80, baseline|Waist and Hip Ratio, Waist and hip circumference measurements serve as cost-effective, non-invasive indicators of body fat distribution and disease risk. High Intra class Correlations (ICC) between self and technician measurements are observed, with values of 0.97 for waist and 0.96 for hip circumference. Additionally, self-measurements at home exhibit high test-retest reliability, with ICC values of at least 0.87 when compared to lab measurements, baseline|BMI, Body Mass Index (BMI) is a measure utilizing height and weight to assess obesity, with values ranging from \<18.5 to \>30. BMI demonstrates high reliability, with an Intra class Correlation Coefficient (ICC) of 0.96, baseline