Insulin ResistanceNCT05961020
Effect of Whole-body Vibration on Insulin Resistance in Obese Postmenopausal Women.
A study testing Total body vibration and moderate restricted diet in people with Insulin Resistance, run by October 6 University at 1 site in Egypt.
Trial summary
This study will be conducted to investigate the Effect of whole-body vibration on insulin resistance in obese postmenopausal women Read more about this study
- Who is it for?
- Ages 50 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Insulin Resistance
- What is being tested?
- Total body vibration and moderate restricted diet
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Nov 2022to 8 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Insulin Resistance
- Being tested
- Total body vibration, moderate restricted diet
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total body vibrationDevice
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
moderate restricted dietOther
moderate restricted diet
| Study group | Role | What they receive |
|---|---|---|
| 20 women was treated by moderate restricted diet for 3 months. | Experimental | Not described Receives: Other: moderate restricted diet |
| 20 women treated by whole body vibration. | Experimental | Not described Receives: Device: Total body vibration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: up to 3 months
BMI
Weight and height were measured to detect the BMI according to the following equation: BMI= weight/height² (Kg/m²)
Measured: 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.
Measured: 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
Measured: up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start5 Nov 2022
- Primary completion3 Jan 2023
- Study completion8 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insulin ResistanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- October 6 University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kerolous Ishak Shehata, October 6 University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05961020
- Sponsor's protocol ID
- p.t.REC\012\004551
- Status last verified
- May 2024
- First submitted
- 6 Jul 2023
- Last updated
- 17 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Whole-body Vibration on Insulin Resistance in Obese Postmenopausal Women.
- ClinicalTrials.gov ID
- NCT05961020
- Acronym / sponsor ID
- p.t.REC\012\004551
- Conditions
- Insulin Resistance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- October 6 UniversityUniversity, hospital or other
- Study start
- 5 Nov 2022 (actual)
- Primary completion
- 3 Jan 2023 (actual)
- Study completion
- 8 Jul 2023 (actual)
- First posted
- 27 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 50 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Total body vibrationWhole-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 | Device | 20 women treated by whole body vibration. |
| moderate restricted dietmoderate restricted diet | Other | 20 women was treated by moderate restricted diet for 3 months. |
Primary outcome
The Homeostatic model assessment (The HOMA-IR).
Time frame: 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)
BMI
Time frame: up to 3 months
Weight and height were measured to detect the BMI according to the following equation: BMI= weight/height² (Kg/m²)
Waist circumference
Time frame: 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.
Skin fold thickness
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Total body vibration and moderate restricted diet in people with Insulin Resistance, run by October 6 University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Homeostatic model assessment (The HOMA-IR). (time frame: up to 3 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2024.