Clinical trial NCT06479590: Effects of Transcranial Direct Current Stimulation on Glucose Level
Official title: Investigate the Effects of Transcranial Direct Current Stimulation on Glucose Level in Healthy Young Adults: Crossover RCT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glucose Metabolism Disorders
Keywords: tDCS
glucose uptake
healthy young
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-06-28
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: RBS
timeFrame: 2-4 hours
measure: 6 Minute walk test
timeFrame: baseline
Secondary outcomes:
measure: International physical activity questionnaire (IPAQ-SF)
timeFrame: baseline
measure: Rapid Assessment of Physical Activity (RAPA)
timeFrame: baseline
measure: Finish Diabetes Risk Score
timeFrame: baseline
measure: GAD-7
timeFrame: baseline
measure: Waist and Hip Ratio
timeFrame: baseline
measure: BMI
timeFrame: baseline
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Pakistan Railway General Hospital
state: Punjab
Study officials:
affiliation: Riphah International University
name: Sumaiyah Obaid, MSPT
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kraus C, Hahn A, Sigurdardottir H, Spurny B, Wadsak W, Mitterhauser M, Hacker M, Kasper S, Lanzenberger R. Brain glucose uptake during transcranial direct current stimulation measured with functional [18F]FDG-PET. Brain Imaging Behav. 2020 Apr;14(2):477-484. doi: 10.1007/s11682-019-00195-4.
citation: Kistenmacher A, Manneck S, Wardzinski EK, Martens JC, Gohla G, Melchert UH, Jauch-Chara K, Oltmanns KM. Persistent blood glucose reduction upon repeated transcranial electric stimulation in men. Brain Stimul. 2017 Jul-Aug;10(4):780-786. doi: 10.1016/j.brs.2017.03.011. Epub 2017 Mar 25.
citation: Binkofski F, Loebig M, Jauch-Chara K, Bergmann S, Melchert UH, Scholand-Engler HG, Schweiger U, Pellerin L, Oltmanns KM. Brain energy consumption induced by electrical stimulation promotes systemic glucose uptake. Biol Psychiatry. 2011 Oct 1;70(7):690-5. doi: 10.1016/j.biopsych.2011.05.009. Epub 2011 Jun 24.