Effects of Whole-body Vibration Therapy on Type 2 Diabetic Patients With and Without Polyneuropathy

Type 2 Diabetes Clinical Trial

Official title:

Effects of Whole-body Vibration Therapy on Type 2 Diabetic Patients With and Without Polyneuropathy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06033508
• Other study ID #: E-60116787-020-338517
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 1, 2024
• Est. completion date: December 1, 2024

Study information

• Verified date: January 2024
• Source: Pamukkale University
• Contact: GULIN FINDIKOGLU, MD PhD
• Phone: 90 258 2966000
• Email: gulin_dr[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 1, 2024
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Participants must stand and walk o without using an assistive device.

2. Participants must have a weight of less than 120 kg.

Exclusion Criteria:

1. T2DM patients with advanced cardiovascular, renal, hepatic disease

2. T2DM patients with diabetic retinopathy or nephropathy

3. T2DM patients with untreated hypertension, rhythm disorders, and those who have undergone bypass surgery

4. T2DM patients with ischemic changes in the resting ECG

5. T2DM patients with untreated hypoglycemia or orthostatic hypotension

6. T2DM patients who are unable to walk independently, or use of canes, crutches or wheelchairs

7. T2DM patients who have open ulcers or wounds on load-bearing surfaces

8. T2DM patients with inflammatory rheumatic diseases such as rheumatoid arthritis

9. T2DM patients with active infectious disease

10. T2DM patients with high risk of thrombosis, those with deep vein thrombosis

11. T2DM patients who carry a pacemaker, prosthesis, intrauterine device or metal implant,

12. T2DM patients with a history of cancer

13. T2DM patients with severe migraine, epilepsy, stroke or other neurological disorders, those who have undergone brain surgery

14. T2DM patients with non-diabetic neuropathy due to reasons such as HIV, AIDS, alcohol, uremia

15. T2DM patients with cognitive impairment

16. T2DM patients who are on psychotropic or neurotoxic therapy

17. T2DM patients with advanced balance problems

18. T2DM patients who are pregnant or breastfeeding mothers

19. T2DM patients who are organ transplant recipients

20. T2DM patients with hernia

21. T2DM patients with kidney or bladder stones

22. T2DM patients who are exposed to mechanical vibration due to their job

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Diabetic Peripheral Neuropathy
• Exercise
• Peripheral Nervous System Diseases
• Polyneuropathies
• Type 2 Diabetes

Intervention

Other:
• exercise with whole body vibration device
exercise with whole body vibration device
• placebo exercise
exercise without vibration on land

Locations

Country	Name	City	State
Turkey	Pamukkale University	Denizli

Sponsors (1)

Lead Sponsor	Collaborator
Pamukkale University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	inflammatory markers	level of CRP	12 weeks