CClinicalTrials.gg
CompletedNCT05961020Updated May 17, 2024

Effect of Whole-body Vibration on Insulin Resistance in Obese Postmenopausal Women.

An interventional study of Total body vibration and moderate restricted diet in Insulin Resistance, sponsored by October 6 University. Completed at 1 site in Egypt. Open to female participants aged 50 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-17.

Sponsored by October 6 University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 8 months after the study started (first participant enrolled Nov 2022, registered Jul 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
50 Years to 60 Years
Sex
Female
01

Study summary

This study will be conducted to investigate the Effect of whole-body vibration on insulin resistance in obese postmenopausal women

Read the detailed description

The prevalence of obesity has tripled over the past four decades, imposing an enormous burden on people's health.

Obesity is associated with premature mortality and is a serious public health threat that accounts for a large proportion of the worldwide non-communicable disease burden, including type 2 diabetes, cardiovascular disease, hypertension, and certain cancers.

reported that "Whole-body vibration (WBV) training has been established as a useful method to improve physical fitness in obese individuals. Vibration stimulus during half squatting might suggest a long-term effect of WBV on the endocrine system. Therefore, in this study, The aim to investigate the effect of whole-body vibration on insulin resistance in obese postmenopausal.

02

Conditions studied

  • Insulin Resistance

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03

In context

Insulin Resistance

1,960 studies on the registry are indexed under Insulin Resistance; 306 are open to participants now.

This study's enrollment of 40 is close to the median of 40 across 1,536 interventional studies indexed under Insulin Resistance.

Browse Insulin Resistance studies →

Lead sponsor

October 6 University is the lead sponsor of 135 studies on the registry; 27 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 60 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • All women were postmenopausal with no menses at least 1 year.
  • Their ages were ranged from 50-60 years old.
  • Their body mass index (BMI) > 30 kg/m2.
  • They were not engaged in any other treatment program.

Exclusion criteria

Exclusion Criteria:

  • Women with body mass index (BMI) \< 30 kg/m2.
  • Any cardio-respiratory diseases.
  • Diabetes mellitus.
  • with malignancy.
  • with severe hemorrhage, acute viral disease and mental disorders.
  • Smokers.
  • Women with life threatening disorders as renal failure
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    20 women was treated by moderate restricted diet for 3 months.

    Other: moderate restricted diet

  • Experimental
    20 women treated by whole body vibration.

    Device: Total body vibration

Interventions

  • DeviceTotal body vibration

    Whole-body vibration (WBV) training has been established as a useful method to improve physical fitness in obese individuals. Vibration stimulus during half squatting might suggest a long-term effect of WBV on the endocrine system

  • Othermoderate restricted diet

    moderate restricted diet

06

What researchers measure

Primary outcomes

  1. The Homeostatic model assessment (The HOMA-IR).

    The Homeostatic model assessment (The HOMA-IR). A sample of 5ml of venous blood sample was drawn from all women after 12 hours fasting for measurement of fasting blood glucose, fasting blood insulin and then detection of insulin resistance (by HOMA -IR) through the equation: HOMA-IR=(Glucose ×Insulin)/405 glucose in mass unit (mg/dl)

    Time frame: up to 3 months

  2. BMI

    Weight and height were measured to detect the BMI according to the following equation: BMI= weight/height² (Kg/m²)

    Time frame: up to 3 months

  3. Waist circumference

    A non-stretchable tape measurement was used to measure waist circumference for all women in both groups A and B: mid-way between upper border of the lateral iliac crest and the lower border of the lowest rib at the end of gentle expiration with arm relaxed at sides.

    Time frame: up to 3 months

  4. Skin fold thickness

    Skin fold caliper was used to measure skin fold thickness at abdominal region for all women in both groups A and B

    Time frame: up to 3 months

07

Study locations

1 site
  • Kerolous Ishak Shehata kelini
    Cairo, Egypt
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 17, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05961020
Lead sponsor
October 6 University
Responsible party
Kerolous Ishak Shehata (principle investigator, October 6 University) — Principal investigator
First posted
Jul 27, 2023
Start date
Nov 5, 2022
Primary completion
Jan 3, 2023
Completion
Jul 8, 2023
Last update
May 17, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.

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