NCT07350473

Brief Summary

The World Health Organization ranks Saudi Arabia as having the 7th highest rate of type-2 diabetes in the world. This therefore makes diabetes the most challenging health problem facing Saudi Arabia. Importantly, physical activity has been shown to improve disease symptoms and overall health in patients with type-2 diabetes. However, findings relating to the prevalence of physical inactivity in the Saudi population confirm that a sedentary lifestyle is on the rise, within physical inactivity levels in adults being 80.5%. Therefore, interventions aimed at reducing physical inactivity using bespoke modalities pertinent to Saudi Arabia are clearly warranted. There have been no fully powered, placebo-controlled trials of localised wearable calf vibration in T2DM within the Kingdom of Saudi Arabia. The proposed study will address this gap by evaluating a 12 week, home based, seated calf vibration intervention in Saudi adults with T2DM, recruited from the Jazan Diabetes and Endocrinology Center. A three-arm design will compare active localised vibration, a sham vibration condition and usual care.

Trial Health

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Trial Health Score

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

Enrollment
305

participants targeted

Target at P75+ for not_applicable diabetes-mellitus-type-2

Timeline
37mo left

Started Dec 2026

Longer than P75 for not_applicable diabetes-mellitus-type-2

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 9, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 20, 2026

Completed
11 months until next milestone

Study Start

First participant enrolled

December 1, 2026

Expected
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2029

6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2029

Last Updated

February 23, 2026

Status Verified

February 1, 2026

Enrollment Period

2.5 years

First QC Date

January 9, 2026

Last Update Submit

February 19, 2026

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (2)

  • HBA1c (Glycated hemoglobin)

    Glycated hemoglobin is a form of hemoglobin that is chemically linked to a sugar. This parameter will be obtained via a venous blood sample.

    Baseline

  • HBA1c (Glycated hemoglobin)

    Glycated hemoglobin is a form of hemoglobin that is chemically linked to a sugar. This parameter will be obtained via a venous blood sample.

    12 weeks

Secondary Outcomes (30)

  • WHO Well-Being Index (WHO-5)

    Baseline

  • WHO Well-Being Index (WHO-5)

    12 weeks

  • Patient Health Questionnaire-9 (PHQ-9)

    Baseline

  • Patient Health Questionnaire-9 (PHQ-9)

    12 weeks

  • Pittsburgh Sleep Quality Index (PSQI)

    Baseline

  • +25 more secondary outcomes

Study Arms (3)

Localized Vibration

EXPERIMENTAL
Device: Localized vibration

Placebo vibration

SHAM COMPARATOR
Other: Placebo vibration

Usual care

OTHER
Other: Usual care

Interventions

Localized vibrationDEVICE

Participants allocated to the localized vibration group will complete home based sessions five times per week for 12 weeks. Each session will last approximately 60 minutes and will consist of four 10 minute bouts of focal muscle vibration separated by 5 minute seated rest periods. Participants will be seated with hips and knees at roughly 90 degrees and will perform repeated calf raises, executing plantarflexion within an approximate 0-45° range at a cadence of 60 repetitions per minute.

Localized Vibration
Placebo vibrationOTHER

Participants allocated to the placebo group will follow an identical protocol to the active vibration arm, including the same session frequency, activity and durations. However, they will use a sham version of the wearable device that emits only negligible vibration, providing minimal cutaneous sensation without delivering a meaningful therapeutic dose.

Placebo vibration
Usual careOTHER

Usual care.

Usual care

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinically established diagnosis of type-2 diabetes for at least 12 months
  • Previously sedentary
  • Knowledgeable about hypoglycaemia
  • Aged over 18 years
  • Capacity to give informed consent.

You may not qualify if:

  • Cognitive impairment precluding consent or participation
  • Pregnancy
  • Additional medical conditions that prevent safe physical activity (e.g. severe arthritis or advanced heart failure)
  • Enrolment in any other clinical trial designed to influence type-2 diabetes symptoms.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Central Study Contacts

Jonathan Sinclair, DSc

CONTACT

787565153jksinclair@lancashire.ac.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 9, 2026

First Posted

January 20, 2026

Study Start (Estimated)

December 1, 2026

Primary Completion (Estimated)

June 1, 2029

Study Completion (Estimated)

December 1, 2029

Last Updated

February 23, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share