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

Sponsor
October 6 University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05961020
Collaborator
(none)
40
2
4

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: Total body vibration
  • Other: moderate restricted diet
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effect of Whole-body Vibration on Insulin Resistance in Obese Postmenopausal Women.
Anticipated Study Start Date :
Jul 1, 2023
Anticipated Primary Completion Date :
Nov 1, 2023
Anticipated Study Completion Date :
Nov 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: 20 women was treated by moderate restricted diet for 3 months.

Other: moderate restricted diet
moderate restricted diet

Experimental: 20 women treated by whole body vibration.

Device: Total 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

Outcome Measures

Primary Outcome Measures

  1. The Homeostatic model assessment (The HOMA-IR). [up to 3 months]

    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)

  2. BMI [up to 3 months]

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

  3. Waist circumference [up to 3 months]

    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.

  4. Skin fold thickness [up to 3 months]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years to 60 Years
Sexes Eligible for Study:
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:
  • 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • October 6 University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Kerolous Ishak Shehata, principle investigator, October 6 University
ClinicalTrials.gov Identifier:
NCT05961020
Other Study ID Numbers:
  • p.t.REC\012\004551
First Posted:
Jul 27, 2023
Last Update Posted:
Jul 27, 2023
Last Verified:
Jul 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 27, 2023