An interventional study of Localized vibration and Placebo vibration in Diabetes Mellitus, Type 2, sponsored by University of Central Lancashire. Not yet recruiting. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-02-23.
Sponsored by University of Central Lancashire · Not applicable, Interventional, and Treatment
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.
10,371 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,406 are open to participants now.
This study's planned enrollment of 305 is above the median of 80 across 8,350 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →University of Central Lancashire is the lead sponsor of 31 studies on the registry; 10 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: Localized vibration
Other: Placebo vibration
Other: Usual care
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.
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 care.
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.
Time frame: 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.
Time frame: 12 weeks
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 12 weeks
Physical fitness
Physical fitness will be examined via the Chester Step test.
Time frame: Baseline
Physical fitness
Physical fitness will be examined via the Chester Step test.
Time frame: 12 weeks
Fasting glucose
Fasting glucose levels will be examined via a venous blood sample.
Time frame: Baseline
Fasting glucose
Fasting glucose levels will be examined via a venous blood sample.
Time frame: 12 weeks
Systolic blood pressure
Systolic blood pressure using blood pressure monitor with blood pressure cuff on the arm.
Time frame: Baseline
Systolic blood pressure
Systolic blood pressure using blood pressure monitor with blood pressure cuff on the arm.
Time frame: 12 weeks
Diastolic blood pressure
Diastolic blood pressure using blood pressure monitor with blood pressure cuff on the arm.
Time frame: Baseline
Diastolic blood pressure
Diastolic blood pressure using blood pressure monitor with blood pressure cuff on the arm.
Time frame: 12 weeks
Body mass
Body mass in kg measured via an electric scale.
Time frame: Baseline
Body mass
Body mass in kg measured via an electric scale.
Time frame: 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.
Time frame: Baseline
Body mass index
Body mass index will be quantified using the standard body mass index equation using measures of body mass and stature.
Time frame: 12 weeks
Triglyceride-glucose index
The triglyceride-glucose index will be calculated using a logarithm of the fasting triglyceride and glucose indices.
Time frame: Baseline
Triglyceride-glucose index
The triglyceride-glucose index will be calculated using a logarithm of the fasting triglyceride and glucose indices.
Time frame: 12 weeks
Total cholesterol
This parameter will be obtained via a venous blood sample.
Time frame: Baseline
Total cholesterol
This parameter will be obtained via a venous blood sample.
Time frame: 12 weeks
HDL cholesterol
This parameter will be obtained via a venous blood sample.
Time frame: Baseline
HDL cholesterol
This parameter will be obtained via a venous blood sample.
Time frame: 12 weeks
LDL cholesterol
This parameter will be obtained via a venous blood sample.
Time frame: Baseline
LDL cholesterol
This parameter will be obtained via a venous blood sample.
Time frame: 12 weeks
Triglycerides
This parameter will be obtained via a venous blood sample.
Time frame: Baseline
Triglycerides
This parameter will be obtained via a venous blood sample.
Time frame: 12 weeks
Single Leg Stance
Static balance by recording how long a patient can stand on one leg unassisted.
Time frame: Baseline
Single Leg Stance
Static balance by recording how long a patient can stand on one leg unassisted.
Time frame: 12 weeks
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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University of Central Lancashire