NCT05961020

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2022

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 5, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 3, 2023

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 6, 2023

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 8, 2023

Completed
19 days until next milestone

First Posted

Study publicly available on registry

July 27, 2023

Completed
Last Updated

May 17, 2024

Status Verified

May 1, 2024

Enrollment Period

2 months

First QC Date

July 6, 2023

Last Update Submit

May 15, 2024

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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

  • BMI

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

    up to 3 months

  • 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

  • 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

Study Arms (2)

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

EXPERIMENTAL
Other: moderate restricted diet

20 women treated by whole body vibration.

EXPERIMENTAL
Device: Total body vibration

Interventions

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

20 women treated by whole body vibration.

moderate restricted diet

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

Eligibility Criteria

Age50 Years - 60 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kerolous Ishak Shehata kelini

Cairo, Egypt

Location

MeSH Terms

Conditions

Insulin Resistance

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator

Study Record Dates

First Submitted

July 6, 2023

First Posted

July 27, 2023

Study Start

November 5, 2022

Primary Completion

January 3, 2023

Study Completion

July 8, 2023

Last Updated

May 17, 2024

Record last verified: 2024-05

Locations