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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05961020
Other study ID # p.t.REC\012\004551
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 5, 2022
Est. completion date July 8, 2023

Study information

Verified date May 2024
Source October 6 University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date July 8, 2023
Est. primary completion date January 3, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 50 Years to 60 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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
Other:
moderate restricted diet
moderate restricted diet

Locations

Country Name City State
Egypt Kerolous Ishak Shehata kelini Cairo

Sponsors (1)

Lead Sponsor Collaborator
October 6 University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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)
up to 3 months
Primary BMI Weight and height were measured to detect the BMI according to the following equation: BMI= weight/height² (Kg/m²) up to 3 months
Primary 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. up to 3 months
Primary 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 up to 3 months
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