NCT06479590

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 24, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 28, 2024

Completed
3 days until next milestone

Study Start

First participant enrolled

July 1, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2025

Completed
Last Updated

March 24, 2025

Status Verified

March 1, 2025

Enrollment Period

6 months

First QC Date

June 24, 2024

Last Update Submit

March 19, 2025

Conditions

Glucose Metabolism Disorders

Keywords

tDCSglucose uptakehealthy young

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (6)

  • International physical activity questionnaire (IPAQ-SF)

    baseline

  • Rapid Assessment of Physical Activity (RAPA)

    baseline

  • Finish Diabetes Risk Score

    baseline

  • GAD-7

    baseline

  • Waist and Hip Ratio

    baseline

  • +1 more secondary outcomes

Study Arms (2)

tDCS Group

EXPERIMENTAL
Device: tDCS

Sham Group

SHAM COMPARATOR
Other: Sham tDCS

Interventions

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)

tDCS Group
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

Sham Group

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pakistan Railway General Hospital

Rawalpindi, Punjab Province, Pakistan

Location

Related Publications (3)

  • 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.

    PMID: 31598826BACKGROUND

  • 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.

    PMID: 28392373BACKGROUND

  • 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.

    PMID: 21703596BACKGROUND

MeSH Terms

Conditions

Glucose Metabolism Disorders

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Metabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Officials

  • Sumaiyah Obaid, MSPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 24, 2024

First Posted

June 28, 2024

Study Start

July 1, 2024

Primary Completion

December 31, 2024

Study Completion

January 31, 2025

Last Updated

March 24, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)