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

Primary Purpose

Insulin Resistance

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Total body vibration
moderate restricted diet
Sponsored by
October 6 University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insulin Resistance

Eligibility Criteria

50 Years - 60 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

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

    20 women treated by whole body vibration.

    Arm Description

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Full Information

    First Posted
    July 6, 2023
    Last Updated
    October 13, 2023
    Sponsor
    October 6 University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05961020
    Brief Title
    Effect of Whole-body Vibration on Insulin Resistance in Obese Postmenopausal Women.
    Official Title
    Effect of Whole-body Vibration on Insulin Resistance in Obese Postmenopausal Women.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 2023 (Anticipated)
    Primary Completion Date
    November 2023 (Anticipated)
    Study Completion Date
    November 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    October 6 University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Insulin Resistance

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    20 women was treated by moderate restricted diet for 3 months.
    Arm Type
    Experimental
    Arm Title
    20 women treated by whole body vibration.
    Arm Type
    Experimental
    Intervention Type
    Device
    Intervention Name(s)
    Total body vibration
    Intervention Description
    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
    Intervention Type
    Other
    Intervention Name(s)
    moderate restricted diet
    Intervention Description
    moderate restricted diet
    Primary Outcome Measure Information:
    Title
    The Homeostatic model assessment (The HOMA-IR).
    Description
    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
    Title
    BMI
    Description
    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
    Title
    Waist circumference
    Description
    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
    Title
    Skin fold thickness
    Description
    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

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    50 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Kerolous Kelini
    Phone
    +201229712126
    Email
    Kerolous.ishak.pt@o6u.edu.eg

    12. IPD Sharing Statement

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