Diabetes Mellitus, Type 2NCT05083767
Effect of Whole Body Vibration Training on Glycemic Control in Type II Diabetic Patients
A study testing Experimental in people with Diabetes Mellitus, Type 2, run by Ameen Medical and Dental Center at 1 site in Pakistan.
Trial summary
Worldwide, the non-communicable diseases are increasing at an alarming rate in which the cardiovascular diseases and Diabetes Mellitus (DM) are predominantly common in lower middle income countries. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Experimental
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- 3 Apr 2019to 22 May 2020
- 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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetic patients
- Age between 40-70 years
Who cannot join
- Diagnosed neurological and cardiovascular condition
- Untreated orthostatic hypotension
- unwilling to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Whole Body Vibration Training on Glycemic Control in Type II Diabetic Patients: A Randomized Control Trial
Worldwide, the non-communicable diseases are increasing at an alarming rate in which the cardiovascular diseases and Diabetes Mellitus (DM) are predominantly common in lower middle income countries. According to Center of Disease Control and Prevention, Diabetes Mellitus (DM) is the 7th leading cause of mortality in United States that may leads to visual deficits, limb amputations, and organ failure. The prevalence of diabetes in the last few decades has increased along with obesity. According to World Health Organization (WHO) the world wide prevalence of DM has increased up to 422 million people and out of this majority lived in the low-and middle income countries. Almost 1.6 million of death is directly attributed to diabetes. According to International Diabetic Foundation, by the end of 2040, DM will affect up to 642 million of the world population. In Pakistan, WHO reported that 12.9 million patients (10% of the population) have diabetes, 9.4 million patients have diagnosed diabetes, and 3.5 million have not been diagnosed. On the contrary, 38 million people have prediabetes (20.5% women and 15.9% men). Another research has shown that Pakistan is ranked on 7th out of 10 countries with Type II diabetes and will be 4th by 2030. Moreover, about 120,000 people in Pakistan have been reported to die each year as the result of type II diabetes and relative complicated diseases. The keystone of diabetes management includes pharmacological management and changes in the lifestyle that includes physical activity and diet. Regular exercises not only improve the cardiovascular fitness but also help in improving the regulation of blood glucose there by enhance insulin signaling, improved vascular function and blood lipids, as well as reduced low-grade inflammation, and weight loss. Researchers suggested that physical activity can boost insulin sensitivity for patients with type II diabetes and help to reduce high blood glucose levels. During exercise, the intake of oxygen can increase up to 20 times and is greatly increased in working muscles. However, receptivity to perform exercises among general population is poor; mainly due to substantial commitment of time associated in performing these exercises. As a passive interference, therefore, Whole-body vibration (WBV) was introduced. Vibration training elevates, energy utilization and increases the blood flow of periphery. Hence the current study was focused on examining the effects of WBV on HbA1c and Fasting Blood Sugar (FBS) in type II diabetic patients.
Read the detailed description
A double-blinded randomized controlled trial was conducted among type-II diabetic patients; aged 40-70 years recruited between April 2019 to May 2020 using simple random sampling technique's envelope method from a primary care center of Karachi. All the participants were initially screened by two certified diabetes educators and certified health fitness programmers. Participants were given informed consent prior to intervention, their voluntary participation and understanding of the protocol was ensured prior to the commencement of protocol.
Participants who met the inclusion criteria were assigned by computer-generated number into two groups A and B (n=15) in each group. Group A was provided with Whole Body Vibration (WBV) for twelve weeks whereas Group B (control group) was instructed to continue their medications and dietary plan. The outcome measure of the study was FBS and HbA1c.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Experimental, Control
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExperimentalOther
The study protocol of WBV includes twelve weeks of whole-body vibration training provided to the Type 2 diabetic patients. It was recommended to all participants that they follow their regular diet and medication during the training. Two sets of six 1-minute vibration squats were designed with 20 seconds of rest, 3 times weekly for a duration 12 weeks (total workout time 36 minutes a week), using a vertical vibration machine. The six static positions consisted of (a) a deep squat position (knee angle 900) (b) an elevated squat position (knee angle 1250) (c) an elevated squat position (with elevated heels) (d) a slight knee flexion1 (hand straps with shoulder bending) (e) a slight knee flexion (hand straps with shoulder abduction) and (f) a slight knee flexion 3 (hand straps with elbow flexion). The training load steadily increased from the initial vibration of 30 Hz and the platform amplitude was raised from 2 mm at week 1 to 40 Hz and from 4 mm at week 5 to the completion of training.
ControlOther
The control group was advised to their normal physical activity level, diet, and medication.
| Study group | Role | What they receive |
|---|---|---|
| Whole Body Vibration | Experimental | Not described Receives: Other: Experimental |
| Control Group | Placebo comparator | Not described Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
Measured: Baseline
HbA1c
Measured: 12 weeks
Fasting Blood Sugar
Measured: Baseline
Fasting Blood Sugar
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2021
- Study start3 Apr 2019
- Primary completion22 May 2020
- Study completion22 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ameen Medical and Dental Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sobia Hasan, Ameen Medical and Dental Center
- Investigators
- Sobia Hasan, MS, Principal investigator, Ameen Medical and Dental Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05083767
- Sponsor's protocol ID
- AmeenMDC
- Status last verified
- Oct 2021
- First submitted
- 6 Oct 2021
- Last updated
- 19 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Whole Body Vibration Training on Glycemic Control in Type II Diabetic Patients: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT05083767
- Acronym / sponsor ID
- AmeenMDC
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Ameen Medical and Dental CenterUniversity, hospital or other
- Study start
- 3 Apr 2019 (actual)
- Primary completion
- 22 May 2020 (actual)
- Study completion
- 22 May 2020 (actual)
- First posted
- 19 Oct 2021 (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.
Worldwide, the non-communicable diseases are increasing at an alarming rate in which the cardiovascular diseases and Diabetes Mellitus (DM) are predominantly common in lower middle income countries. According to Center of Disease Control and Prevention, Diabetes Mellitus (DM) is the 7th leading cause of mortality in United States that may leads to visual deficits, limb amputations, and organ failure. The prevalence of diabetes in the last few decades has increased along with obesity. According to World Health Organization (WHO) the world wide prevalence of DM has increased up to 422 million people and out of this majority lived in the low-and middle income countries. Almost 1.6 million of death is directly attributed to diabetes. According to International Diabetic Foundation, by the end of 2040, DM will affect up to 642 million of the world population. In Pakistan, WHO reported that 12.9 million patients (10% of the population) have diabetes, 9.4 million patients have diagnosed diabetes, and 3.5 million have not been diagnosed. On the contrary, 38 million people have prediabetes (20.5% women and 15.9% men). Another research has shown that Pakistan is ranked on 7th out of 10 countries with Type II diabetes and will be 4th by 2030. Moreover, about 120,000 people in Pakistan have been reported to die each year as the result of type II diabetes and relative complicated diseases. The keystone of diabetes management includes pharmacological management and changes in the lifestyle that includes physical activity and diet. Regular exercises not only improve the cardiovascular fitness but also help in improving the regulation of blood glucose there by enhance insulin signaling, improved vascular function and blood lipids, as well as reduced low-grade inflammation, and weight loss. Researchers suggested that physical activity can boost insulin sensitivity for patients with type II diabetes and help to reduce high blood glucose levels. During exercise, the intake of oxygen can increase up to 20 times and is greatly increased in working muscles. However, receptivity to perform exercises among general population is poor; mainly due to substantial commitment of time associated in performing these exercises. As a passive interference, therefore, Whole-body vibration (WBV) was introduced. Vibration training elevates, energy utilization and increases the blood flow of periphery. Hence the current study was focused on examining the effects of WBV on HbA1c and Fasting Blood Sugar (FBS) in type II diabetic patients.
Detailed description
A double-blinded randomized controlled trial was conducted among type-II diabetic patients; aged 40-70 years recruited between April 2019 to May 2020 using simple random sampling technique's envelope method from a primary care center of Karachi. All the participants were initially screened by two certified diabetes educators and certified health fitness programmers. Participants were given informed consent prior to intervention, their voluntary participation and understanding of the protocol was ensured prior to the commencement of protocol.
Participants who met the inclusion criteria were assigned by computer-generated number into two groups A and B (n=15) in each group. Group A was provided with Whole Body Vibration (WBV) for twelve weeks whereas Group B (control group) was instructed to continue their medications and dietary plan. The outcome measure of the study was FBS and HbA1c.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Whole Body Vibration | Experimental | Other: Experimental |
| Control Group | Placebo comparator | Other: Control |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Type 2 diabetic patients
- Age between 40-70 years
Key exclusion criteria (3 listed)
- Diagnosed neurological and cardiovascular condition
- Untreated orthostatic hypotension
- unwilling to participate
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 |
|---|---|---|
| ExperimentalThe study protocol of WBV includes twelve weeks of whole-body vibration training provided to the Type 2 diabetic patients. It was recommended to all participants that they follow their regular diet and medication during the training. Two sets of six 1-minute vibration squats were designed with 20 seconds of rest, 3 times weekly for a duration 12 weeks (total workout time 36 minutes a week), using a vertical vibration machine. The six static positions consisted of (a) a deep squat position (knee angle 900) (b) an elevated squat position (knee angle 1250) (c) an elevated squat position (with elevated heels) (d) a slight knee flexion1 (hand straps with shoulder bending) (e) a slight knee flexion (hand straps with shoulder abduction) and (f) a slight knee flexion 3 (hand straps with elbow flexion). The training load steadily increased from the initial vibration of 30 Hz and the platform amplitude was raised from 2 mm at week 1 to 40 Hz and from 4 mm at week 5 to the completion of training. | Other | Whole Body Vibration |
| ControlThe control group was advised to their normal physical activity level, diet, and medication. | Other | Control Group |
Primary outcome
HbA1c
Time frame: Baseline
HbA1c
Time frame: 12 weeks
Fasting Blood Sugar
Time frame: Baseline
Fasting Blood Sugar
Time frame: 12 weeks
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 19 Oct 2021.
- Individual participant dataSharing planned: No
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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.
Sobia Hasan, MS principal investigator
Ameen Medical and Dental Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental in people with Diabetes Mellitus, Type 2, run by Ameen Medical and Dental Center at 1 site in Pakistan.
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 2 inclusion and 3 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 19 Oct 2021. 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 Pakistan. 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. Some participants in this study may receive a placebo. 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?
HbA1c (time frame: Baseline). 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 19 Oct 2021.