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Completed

NCT Number: NCT06479590

Effects of Transcranial Direct Current Stimulation on Glucose Level

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.

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Key information

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pakistan Railway General Hospital

Rawalpindi, Punjab Province, Pakistan

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Both Male & Female
  • Age 18-30 years

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

Treatment and study plan

tDCS

Device

The DCS electrode sheaths of 7x5 cm will be soaked with standard saline solution(NaCl 9%) and fixed by elastic bands. tDCS will deliver 20 min of anodal stimulation (1-2mA, fade in/out 8 sec)

Sham tDCS

Other

sham-tDCS will be applied for 30 s to make it difficult for the individual to distinguish the placebo from a real tDCS application

Primary outcomes

  1. RBS

    Time frame: 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

  2. 6 Minute walk test

    Time frame: 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 outcomes

  1. International physical activity questionnaire (IPAQ-SF)

    Time frame: 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

  2. Rapid Assessment of Physical Activity (RAPA)

    Time frame: 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

  3. Finish Diabetes Risk Score

    Time frame: 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.

  4. GAD-7

    Time frame: 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

  5. Waist and Hip Ratio

    Time frame: 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

  6. BMI

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

Investigate the Effects of Transcranial Direct Current Stimulation on Glucose Level in Healthy Young Adults: Crossover RCT

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Jun 28, 2024
Registry last updated
Mar 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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