Type 2 DiabetesNCT06033508
Effects of Whole-body Vibration Therapy on Type 2 Diabetic Patients with and Without Polyneuropathy
A study testing exercise with whole body vibration device in people with Type 2 Diabetes and Diabetic Peripheral Neuropathy, run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to show how whole body vibration training practiced for 12 weeks affects the levels of inflammatory biomarkers such as C reactive protein (CRP) and, interleukin-6 (IL-6), in Type 2 diabetic patients (T2DM) with and without peripheral neuropathy. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Type 2 Diabetes, Diabetic Peripheral Neuropathy, Exercise
- What is being tested?
- exercise with whole body vibration device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2024to 1 Nov 2024
- 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 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must stand and walk o without using an assistive device.
- Participants must have a weight of less than 120 kg.
Who cannot join
- T2DM patients with advanced cardiovascular, renal, hepatic disease
- T2DM patients with diabetic retinopathy or nephropathy
- T2DM patients with untreated hypertension, rhythm disorders, and those who have undergone bypass surgery
- T2DM patients with ischemic changes in the resting ECG
- T2DM patients with untreated hypoglycemia or orthostatic hypotension
- T2DM patients who are unable to walk independently, or use of canes, crutches or wheelchairs
Show all 22Show fewer
- T2DM patients who have open ulcers or wounds on load-bearing surfaces
- T2DM patients with inflammatory rheumatic diseases such as rheumatoid arthritis
- T2DM patients with active infectious disease
- T2DM patients with high risk of thrombosis, those with deep vein thrombosis
- T2DM patients who carry a pacemaker, prosthesis, intrauterine device or metal implant,
- T2DM patients with a history of cancer
- T2DM patients with severe migraine, epilepsy, stroke or other neurological disorders, those who have undergone brain surgery
- T2DM patients with non-diabetic neuropathy due to reasons such as HIV, AIDS, alcohol, uremia
- T2DM patients with cognitive impairment
- T2DM patients who are on psychotropic or neurotoxic therapy
- T2DM patients with advanced balance problems
- T2DM patients who are pregnant or breastfeeding mothers
- T2DM patients who are organ transplant recipients
- T2DM patients with hernia
- T2DM patients with kidney or bladder stones
- T2DM patients who are exposed to mechanical vibration due to their job
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to show how whole body vibration training practiced for 12 weeks affects the levels of inflammatory biomarkers such as C reactive protein (CRP) and, interleukin-6 (IL-6), in Type 2 diabetic patients (T2DM) with and without peripheral neuropathy.
Read the detailed description
Volunteers with type 2 diabetes mellitus with and without peripheric neuropathy will be evaluated in terms of any contra-indication that will restrain them from making exercise with whole body vibration device. 60 male or female volunteers who are suitable in terms of inclusion/exclusion criteria will be invited for the study. Volunteers will be randomly distributed to one of the 3 groups. Each group will contain 20 participants. 1st group will include type 2 diabetic patients with peripheric neuropathy and 2nd and 3rd groups will include type 2 diabetic patients without neuropathy. Patients in group 1 and 2 will make static isometric exercises on vibration platform whereas patients in group 3 will make the same exercises on land in the hospital setting. Participants will be requested to complete 3 months of exercise. They will be evaluated before and at the end of the 3 months of exercise with physical measures such as waist and hip circumference, 6-minute walk test, body composition measured by bioimpedance, muscle thickness, and blood tests to measure inflammatory biomarkers.
- Conditions
- Type 2 Diabetes, Diabetic Peripheral Neuropathy, Exercise
- Being tested
- exercise with whole body vibration device, placebo exercise
- Keywords
- Type 2 diabetes mellitus, Diabetic Peripheral Neuropathy, whole body vibration, inflammation
- Medical subject headings
- Diabetes Mellitus, Type 2, Motor Activity, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exercise with whole body vibration deviceOther
exercise with whole body vibration device
placebo exerciseOther
exercise without vibration on land
| Study group | Role | What they receive |
|---|---|---|
| T2DM with neuropathy + WBV | Active comparator | Patients with type 2 Diabetes mellitus with neuropathy who will be trained by whole body vibration Receives: Other: exercise with whole body vibration device |
| T2DM without neuropathy + WBV | Active comparator | Patients with type 2 Diabetes mellitus without neuropathy who will be trained by whole body vibration Receives: Other: exercise with whole body vibration device |
| T2DM without neuropathy + land exercise | Placebo comparator | Patients with type 2 Diabetes mellitus without neuropathy who will be trained on land Receives: Other: placebo exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
6 min walk test
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 posted13 Sep 2023
- Study start1 Apr 2024
- Primary completion1 Nov 2024
- Study completion1 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Pamukkale UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, GULIN FINDIKOGLU, Pamukkale University
- Investigators
- GULIN FINDIKOGLU, Assoc Prof, Principal investigator, Pamukkale University, Medical Faculty, PMR Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06033508
- Sponsor's protocol ID
- E-60116787-020-338517
- Status last verified
- Nov 2024
- First submitted
- 5 Sep 2023
- Last updated
- 6 Feb 2025
- 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 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Whole-body Vibration Therapy on Type 2 Diabetic Patients with and Without Polyneuropathy
- ClinicalTrials.gov ID
- NCT06033508
- Acronym / sponsor ID
- E-60116787-020-338517
- Conditions
- Type 2 Diabetes, Diabetic Peripheral Neuropathy, Exercise
- Keywords
- Type 2 diabetes mellitus, Diabetic Peripheral Neuropathy, whole body vibration, inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 1 Nov 2024 (actual)
- Study completion
- 1 Nov 2024 (actual)
- First posted
- 13 Sep 2023 (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 aim of this study is to show how whole body vibration training practiced for 12 weeks affects the levels of inflammatory biomarkers such as C reactive protein (CRP) and, interleukin-6 (IL-6), in Type 2 diabetic patients (T2DM) with and without peripheral neuropathy.
Detailed description
Volunteers with type 2 diabetes mellitus with and without peripheric neuropathy will be evaluated in terms of any contra-indication that will restrain them from making exercise with whole body vibration device. 60 male or female volunteers who are suitable in terms of inclusion/exclusion criteria will be invited for the study. Volunteers will be randomly distributed to one of the 3 groups. Each group will contain 20 participants. 1st group will include type 2 diabetic patients with peripheric neuropathy and 2nd and 3rd groups will include type 2 diabetic patients without neuropathy. Patients in group 1 and 2 will make static isometric exercises on vibration platform whereas patients in group 3 will make the same exercises on land in the hospital setting. Participants will be requested to complete 3 months of exercise. They will be evaluated before and at the end of the 3 months of exercise with physical measures such as waist and hip circumference, 6-minute walk test, body composition measured by bioimpedance, muscle thickness, and blood tests to measure inflammatory biomarkers.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| T2DM with neuropathy + WBV | Active comparator | Other: exercise with whole body vibration devicePatients with type 2 Diabetes mellitus with neuropathy who will be trained by whole body vibration |
| T2DM without neuropathy + WBV | Active comparator | Other: exercise with whole body vibration devicePatients with type 2 Diabetes mellitus without neuropathy who will be trained by whole body vibration |
| T2DM without neuropathy + land exercise | Placebo comparator | Other: placebo exercisePatients with type 2 Diabetes mellitus without neuropathy who will be trained on land |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Participants must stand and walk o without using an assistive device.
- Participants must have a weight of less than 120 kg.
Key exclusion criteria (22 listed)
- T2DM patients with advanced cardiovascular, renal, hepatic disease
- T2DM patients with diabetic retinopathy or nephropathy
- T2DM patients with untreated hypertension, rhythm disorders, and those who have undergone bypass surgery
- T2DM patients with ischemic changes in the resting ECG
- T2DM patients with untreated hypoglycemia or orthostatic hypotension
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 |
|---|---|---|
| exercise with whole body vibration deviceexercise with whole body vibration device | Other | T2DM with neuropathy + WBV, T2DM without neuropathy + WBV |
| placebo exerciseexercise without vibration on land | Other | T2DM without neuropathy + land exercise |
Primary outcome
6 min walk test
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2025.
- 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. This study is not recruiting at the moment.
GULIN FINDIKOGLU, Assoc Prof principal investigator
Pamukkale University, Medical Faculty, PMR Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercise with whole body vibration device in people with Type 2 Diabetes and Diabetic Peripheral Neuropathy, run by Pamukkale University at 1 site in Turkey (Türkiye).
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 22 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 6 Feb 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 Turkey (Türkiye). 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?
6 min walk test (time frame: 12 weeks). 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 6 Feb 2025.