NCT06033508

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P50-P75 for not_applicable type-2-diabetes

Timeline
Completed

Started Apr 2024

Shorter than P25 for not_applicable type-2-diabetes

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 5, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 13, 2023

Completed
7 months until next milestone

Study Start

First participant enrolled

April 1, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2024

Completed
Last Updated

February 6, 2025

Status Verified

November 1, 2024

Enrollment Period

7 months

First QC Date

September 5, 2023

Last Update Submit

February 3, 2025

Conditions

Type 2 DiabetesDiabetic Peripheral NeuropathyExercise

Keywords

Type 2 diabetes mellitusDiabetic Peripheral Neuropathywhole body vibrationinflammation

Outcome Measures

Primary Outcomes (1)

  • 6 min walk test

    12 weeks

Study Arms (3)

T2DM with neuropathy + WBV

ACTIVE COMPARATOR

Patients with type 2 Diabetes mellitus with neuropathy who will be trained by whole body vibration

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

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

Other: placebo exercise

Interventions

exercise with whole body vibration deviceOTHER

exercise with whole body vibration device

T2DM with neuropathy + WBVT2DM without neuropathy + WBV
placebo exerciseOTHER

exercise without vibration on land

T2DM without neuropathy + land exercise

Eligibility Criteria

Age30 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants must stand and walk o without using an assistive device.
  • Participants must have a weight of less than 120 kg.

You may not qualify if:

  • 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
  • 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
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pamukkale University

Denizli, Denizli, 21600, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Motor ActivityInflammation

Interventions

Exercise

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesBehaviorPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • GULIN FINDIKOGLU, Assoc Prof

    Pamukkale University, Medical Faculty, PMR Department

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc Prof Dr

Study Record Dates

First Submitted

September 5, 2023

First Posted

September 13, 2023

Study Start

April 1, 2024

Primary Completion

November 1, 2024

Study Completion

November 1, 2024

Last Updated

February 6, 2025

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)