Effects of Transcranial Direct Current Stimulation on Glucose Level

Not Applicable

Not yet recruiting

• Conditions: Glucose Metabolism Disorders
• Interventions: Device: tDCS; Other: Sham tDCS

• Registration Number: NCT06479590
• Lead Sponsor: Riphah International University

Brief 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.

Detailed Description

The proposed study suggests addressing these gaps by employing a large sample size, comprehensive outcome measurements, assessing tDCS impact on diabetes mellitus (DM) risk variables, and integrating ethical considerations into the research design and implementation. The study aims to fill existing gaps in knowledge about tDCS effects on blood glucose regulation and diabetic risk factors by conducting more robust research methodologies The effects of tDCS on addictive behavior and cerebral glucose metabolism in problematic online gamers were examined in a single-blinded RCT. Over a 4-weekperiod, participants received 12 sessions of either active or sham tDCS to the dorsolateral prefrontal cortex. In the active group, glucose metabolism was enhanced in certain brain regions, showing decreased addiction severity in both groups. As a result of these findings, it appears that prefrontal tDCS is capable of controlling gaming behaviors and enhancing cerebral glucose metabolism

Study Timeline

• Status Verified: 2024-06
• Study First Submitted: 2024-06-24
• Study First Submitted QC: 2024-06-24
• Last Update Submitted: 2024-06-24
• Study First Posted: 2024-06-28
• Last Update Posted: 2024-06-28
• Study Start: 2024-07-01
• Primary Completion: 2024-12-31
• Study Completion: 2025-01-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• Both Male & Female
• Age 18-30 years

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Exclusion Criteria

• Pregnancy
• Lactating mothers
• Skin Irritation and Allergies
• Brain Tumor or Shunt
• Brain Metallic implants
• Epileptic disease
• GI Disorder and Endocrine Disorder
• Drug abuse
• History of medications any hormonal therapy

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
tDCS Group	Sham tDCS	-
Sham Group	Sham tDCS	-
tDCS Group	tDCS	-
Sham Group	tDCS	-

Primary Outcome Measures

Name	Time	Method
RBS	2-4 hours	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
6 Minute walk test	baseline	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.

Secondary Outcome Measures

Name	Time	Method
Finish Diabetes Risk Score	baseline	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.
GAD-7	baseline	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
Waist and Hip Ratio	baseline	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
BMI	baseline	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
International physical activity questionnaire (IPAQ-SF)	baseline	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
Rapid Assessment of Physical Activity (RAPA)	baseline	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

Trial Locations

Locations (1)

Pakistan Railway General Hospital; 🇵🇰 Rawalpindi, Punjab, Pakistan