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Glucose Metabolism DisordersNCT06479590

Effects of Transcranial Direct Current Stimulation on Glucose Level

A study testing tDCS in people with Glucose Metabolism Disorders, run by Riphah International University at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 30 yearsHealthy volunteers can take part
Conditions the study is for
Glucose Metabolism Disorders
What is being tested?
tDCS
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
50 participants
Where
1 sitePakistan
Study dates
1 Jul 2024to 31 Jan 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 30 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Both Male \& Female
  • Age 18-30 years

Who cannot join

  • Pregnancy
  • Lactating mothers
  • Skin Irritation and Allergies
  • Brain Tumor or Shunt
  • Brain Metallic implants
  • Epileptic disease
Show all 9Show fewer
  • GI Disorder and Endocrine Disorder
  • Drug abuse
  • History of medications any hormonal therapy

Trial locations and contacts

1 site in 1 country.

Pakistan1 site

  • Pakistan Railway General Hospital

    Rawalpindi, Punjab Province

Other trials in Pakistan

About this study

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

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.

Read the 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

Being tested
tDCS, Sham tDCS
Keywords
tDCS, glucose uptake, healthy young
Medical subject headings
Glucose Metabolism Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • tDCSDevice

    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 tDCSOther

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

Study groups in NCT06479590
Study groupRoleWhat they receive
tDCS GroupExperimentalNot described
Receives: Device: tDCS
Sham GroupSham comparatorNot described
Receives: Other: Sham tDCS

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 2-4 hours

  2. 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.

    Measured: baseline

Secondary outcomes (6)

  1. 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

    Measured: baseline

  2. 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

    Measured: baseline

  3. 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.

    Measured: baseline

  4. 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

    Measured: baseline

  5. 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

    Measured: baseline

  6. 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

    Measured: baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jun 2024
  2. Study start1 Jul 2024
  3. Primary completion31 Dec 2024
  4. Study completion31 Jan 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06479590
Sponsor's protocol ID
REC01893 Faryal Shoukat
Status last verified
Mar 2025
First submitted
24 Jun 2024
Last updated
24 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 31598826

  • 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.

    PubMed 28392373

  • 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.

    PubMed 21703596

Questions about this trial

What is this clinical trial studying?

A study testing tDCS in people with Glucose Metabolism Disorders, run by Riphah International University at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

RBS (time frame: 2-4 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06479590, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2025.

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