Diabetes Mellitus, Type 2VIBRANT-KSANCT07350473
Effects of Vibration-Assisted Physical Activity in Type-2 Diabetes
A study testing Localized vibration in people with Diabetes Mellitus, Type 2, run by University of Central Lancashire.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Localized vibration
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 305 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2026to 1 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Vibration-Assisted Physical Activity for Glycaemic Control in Type-2 Diabetes: A Randomised Controlled Trial in the Kingdom of Saudi Arabia
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.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Localized vibration, Placebo vibration, Usual care
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
Usual careOther
Usual care.
| Study group | Role | What they receive |
|---|---|---|
| Localized Vibration | Experimental | Not described Receives: Device: Localized vibration |
| Placebo vibration | Sham comparator | Not described Receives: Other: Placebo vibration |
| Usual care | Other | Not described Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 12 weeks
Secondary outcomes (30)
WHO Well-Being Index (WHO-5)
The World Health Organisation- Five Well-Being Index (WHO-5) is a short self-reported measure of current mental wellbeing. A score of 0 represents the worst imaginable well-being and 100 represents the best imaginable well-being.
Measured: Baseline
WHO Well-Being Index (WHO-5)
The World Health Organisation- Five Well-Being Index (WHO-5) is a short self-reported measure of current mental wellbeing. A score of 0 represents the worst imaginable well-being and 100 represents the best imaginable well-being.
Measured: 12 weeks
Patient Health Questionnaire-9 (PHQ-9)
The Patient Health Questionnaire-9 (PHQ-9) is the depression module, which has nine questions ranging from "0" (not at all) to "3" (nearly every day). The scoring is interpreted as 0-4 no depression symptoms, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe depression symptoms.
Measured: Baseline
Patient Health Questionnaire-9 (PHQ-9)
The Patient Health Questionnaire-9 (PHQ-9) is the depression module, which has nine questions ranging from "0" (not at all) to "3" (nearly every day). The scoring is interpreted as 0-4 no depression symptoms, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe depression symptoms.
Measured: 12 weeks
Pittsburgh Sleep Quality Index (PSQI)
The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality. The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality.
Measured: Baseline
Pittsburgh Sleep Quality Index (PSQI)
The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality. The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality.
Measured: 12 weeks
Physical fitness
Physical fitness will be examined via the Chester Step test.
Measured: Baseline
Physical fitness
Physical fitness will be examined via the Chester Step test.
Measured: 12 weeks
Fasting glucose
Fasting glucose levels will be examined via a venous blood sample.
Measured: Baseline
Fasting glucose
Fasting glucose levels will be examined via a venous blood sample.
Measured: 12 weeks
Systolic blood pressure
Systolic blood pressure using blood pressure monitor with blood pressure cuff on the arm.
Measured: Baseline
Systolic blood pressure
Systolic blood pressure using blood pressure monitor with blood pressure cuff on the arm.
Measured: 12 weeks
Diastolic blood pressure
Diastolic blood pressure using blood pressure monitor with blood pressure cuff on the arm.
Measured: Baseline
Diastolic blood pressure
Diastolic blood pressure using blood pressure monitor with blood pressure cuff on the arm.
Measured: 12 weeks
Body mass
Body mass in kg measured via an electric scale.
Measured: Baseline
Body mass
Body mass in kg measured via an electric scale.
Measured: 12 weeks
Body mass index
Body mass index will be quantified using the standard body mass index equation using measures of body mass and stature.
Measured: Baseline
Body mass index
Body mass index will be quantified using the standard body mass index equation using measures of body mass and stature.
Measured: 12 weeks
Triglyceride-glucose index
The triglyceride-glucose index will be calculated using a logarithm of the fasting triglyceride and glucose indices.
Measured: Baseline
Triglyceride-glucose index
The triglyceride-glucose index will be calculated using a logarithm of the fasting triglyceride and glucose indices.
Measured: 12 weeks
Total cholesterol
This parameter will be obtained via a venous blood sample.
Measured: Baseline
Total cholesterol
This parameter will be obtained via a venous blood sample.
Measured: 12 weeks
HDL cholesterol
This parameter will be obtained via a venous blood sample.
Measured: Baseline
HDL cholesterol
This parameter will be obtained via a venous blood sample.
Measured: 12 weeks
LDL cholesterol
This parameter will be obtained via a venous blood sample.
Measured: Baseline
LDL cholesterol
This parameter will be obtained via a venous blood sample.
Measured: 12 weeks
Triglycerides
This parameter will be obtained via a venous blood sample.
Measured: Baseline
Triglycerides
This parameter will be obtained via a venous blood sample.
Measured: 12 weeks
Single Leg Stance
Static balance by recording how long a patient can stand on one leg unassisted.
Measured: Baseline
Single Leg Stance
Static balance by recording how long a patient can stand on one leg unassisted.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start1 Dec 2026 (estimated)
- Primary completion1 Jun 2029 (estimated)
- Study completion1 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 305 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Central Lancashire
- Sponsor type
- University, hospital or other
- Collaborators
- University of Jazan, University of Hertfordshire
- Responsible party
- Principal investigator, Jonathan Sinclair, University of Central Lancashire
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07350473
- Sponsor's protocol ID
- Vibration-Assisted Physical Ac
- Acronym
- VIBRANT-KSA
- Status last verified
- Feb 2026
- First submitted
- 9 Jan 2026
- Last updated
- 23 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vibration-Assisted Physical Activity for Glycaemic Control in Type-2 Diabetes: A Randomised Controlled Trial in the Kingdom of Saudi Arabia
- ClinicalTrials.gov ID
- NCT07350473
- Acronym / sponsor ID
- VIBRANT-KSA / Vibration-Assisted Physical Ac
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 305 participants (estimated)
- Lead sponsor
- University of Central LancashireUniversity, hospital or other
- Collaborators
- University of Jazan, University of Hertfordshire
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 1 Jun 2029 (estimated)
- Study completion
- 1 Dec 2029 (estimated)
- First posted
- 20 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Localized Vibration | Experimental | Device: Localized vibration |
| Placebo vibration | Sham comparator | Other: Placebo vibration |
| Usual care | Other | Other: Usual care |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Localized vibrationParticipants 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. | Device | Localized Vibration |
| Placebo vibrationParticipants 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. | Other | Placebo vibration |
| Usual careUsual care. | Other | Usual care |
Primary outcome
HBA1c (Glycated hemoglobin)
Time frame: Baseline
Glycated hemoglobin is a form of hemoglobin that is chemically linked to a sugar. This parameter will be obtained via a venous blood sample.
HBA1c (Glycated hemoglobin)
Time frame: 12 weeks
Glycated hemoglobin is a form of hemoglobin that is chemically linked to a sugar. This parameter will be obtained via a venous blood sample.
30 secondary outcomes
WHO Well-Being Index (WHO-5)
Time frame: Baseline
WHO Well-Being Index (WHO-5)
Time frame: 12 weeks
Patient Health Questionnaire-9 (PHQ-9)
Time frame: Baseline
Patient Health Questionnaire-9 (PHQ-9)
Time frame: 12 weeks
Pittsburgh Sleep Quality Index (PSQI)
Time frame: Baseline
Pittsburgh Sleep Quality Index (PSQI)
Time frame: 12 weeks
Physical fitness
Time frame: Baseline
Physical fitness
Time frame: 12 weeks
Fasting glucose
Time frame: Baseline
Fasting glucose
Time frame: 12 weeks
Systolic blood pressure
Time frame: Baseline
Systolic blood pressure
Time frame: 12 weeks
Diastolic blood pressure
Time frame: Baseline
Diastolic blood pressure
Time frame: 12 weeks
Body mass
Time frame: Baseline
Body mass
Time frame: 12 weeks
Body mass index
Time frame: Baseline
Body mass index
Time frame: 12 weeks
Triglyceride-glucose index
Time frame: Baseline
Triglyceride-glucose index
Time frame: 12 weeks
Total cholesterol
Time frame: Baseline
Total cholesterol
Time frame: 12 weeks
HDL cholesterol
Time frame: Baseline
HDL cholesterol
Time frame: 12 weeks
LDL cholesterol
Time frame: Baseline
LDL cholesterol
Time frame: 12 weeks
Triglycerides
Time frame: Baseline
Triglycerides
Time frame: 12 weeks
Single Leg Stance
Time frame: Baseline
Single Leg Stance
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Localized vibration in people with Diabetes Mellitus, Type 2, run by University of Central Lancashire.
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 5 inclusion and 4 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: opening soon, as of the sponsor's last update on 23 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jonathan Sinclair, DSc (787565153, jksinclair@lancashire.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HBA1c (Glycated hemoglobin) (time frame: Baseline). 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?
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 23 Feb 2026.