DiabetesNCT03542929
Acute Whole Body Vibration Change the Glycemic and Lactate Levels
A study testing whole body vibration in people with Diabetes, run by Maíra F Pessoa at 1 site in Brazil.
Trial summary
The type II diabetes is characterized by high levels of blood glucose followed by excessive insulin release so that the target cells become less sensitive and develop insulin resistance, maintaining hyperglycemic levels. Read more about this study
- Who is it for?
- Ages 60 to 74 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Diabetes
- What is being tested?
- whole body vibration
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteBrazil
- Study dates
- 20 Nov 2017to 30 Apr 2018
- 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 60 to 74 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- elderly between 60 to 74 years,
- sedentary according the International Physical Activity Questionnaire (IPAQ- short form)
- For diabetic group, were considered who those medical diagnoses of type II diabetes for at least 02 complete years, who had used only oral hypoglycemic agents of biguanides class (Metformin extended release - XR) in dosage between 500 to 850 mg.
- For healthy elderly group were considered elderly women without self-reported diseases
Who cannot join
- diabetic volunteers who have ingested the breakfast less than 02 hours or more than 03 hours and those who have taken Metformin less than 02 hours before the intervention.
- For all volunteers, the complementary exclusion criteria were:
- the current or past smoking or alcoholic habits;
- the cardiovascular, liver or neuromuscular diseases;
- subjects with prior labyrinthitis or embolic events;
- who have had any surgery in last year;
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- volunteers with metallic prosthesis as pacemaker, pins or plates;
- volunteers with advanced osteoporosis;
- which had difficulties during the evaluation or acute protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acute Whole Body Vibration Decrease the Glucose Levels in Elderly Diabetic Women
The type II diabetes is characterized by high levels of blood glucose followed by excessive insulin release so that the target cells become less sensitive and develop insulin resistance, maintaining hyperglycemic levels. The Whole body vibration session may improve the glucose metabolism in diabetic patients by reducing the peripheral blood sugar. Ten healthy elderly women and eight diabetic elderly women were allocated into two groups, and have made an acute whole body session.
- Conditions
- Diabetes
- Being tested
- whole body vibration
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
whole body vibrationDevice
whole body vibration training on a vibrating platform with healthy elderly and diabetic elderly
| Study group | Role | What they receive |
|---|---|---|
| healthy elderly | Active comparator | healthy elderly were use the Whole body vibration intervention during 10 minutes Receives: Device: whole body vibration |
| diabetic elderly | Experimental | diabetic elderly were use the Whole body vibration intervention during 10 minutes Receives: Device: whole body vibration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in glucose levels
A digital puncture with disposable lancets was collected a peripheral blood drop in the specific strip for the home glucose monitoring AccuChek Active® (Roche Diagnostics GmbH, Mannheim, Germany) according to International Organization for Standardization (ISO) recommendations in 2013 (11).
Measured: before and immediately after the 10 minute intervention
Changes in lactate levels
Another peripheral blood drop was collected from the same digital puncture with disposable lancets and put in the specific strip for to check the seric blood lactate, which was analyzed by a portable lactimeter Accutrend Plus ® (Roche Accutrend Plus, New York, USA).
Measured: before and immediately after the 10 minute intervention
Secondary outcomes (3)
peripheral oxygen saturation (SpO2)
measured with a digital oximeter Onyx (Nonim, model 9500, USA)
Measured: before and immediately after the 10 minute intervention
heart rate (HR)
measured with a digital oximeter Onyx (Nonim, model 9500, USA)
Measured: before and immediately after the 10 minute intervention
Borg's Rating of Perceived Exertion Scale (RPE) or Modified Borg Scale
visual scale that measure the perceived exertion in muscle or dyspnoea, measuring values between 0 at 10
Measured: before and immediately after the 10 minute intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2018
- Study start20 Nov 2017
- Primary completion20 Mar 2018
- Study completion30 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maíra F Pessoa
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Maíra F Pessoa, Universidade Federal de Pernambuco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03542929
- Sponsor's protocol ID
- Whole body vibration glucose
- Status last verified
- May 2018
- First submitted
- 12 Apr 2018
- Last updated
- 31 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Whole Body Vibration Decrease the Glucose Levels in Elderly Diabetic Women
- ClinicalTrials.gov ID
- NCT03542929
- Acronym / sponsor ID
- Whole body vibration glucose
- Conditions
- Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Maíra F PessoaUniversity, hospital or other
- Study start
- 20 Nov 2017 (actual)
- Primary completion
- 20 Mar 2018 (actual)
- Study completion
- 30 Apr 2018 (actual)
- First posted
- 31 May 2018 (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.
The type II diabetes is characterized by high levels of blood glucose followed by excessive insulin release so that the target cells become less sensitive and develop insulin resistance, maintaining hyperglycemic levels. The Whole body vibration session may improve the glucose metabolism in diabetic patients by reducing the peripheral blood sugar. Ten healthy elderly women and eight diabetic elderly women were allocated into two groups, and have made an acute whole body session.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| healthy elderly | Active comparator | Device: whole body vibrationhealthy elderly were use the Whole body vibration intervention during 10 minutes |
| diabetic elderly | Experimental | Device: whole body vibrationdiabetic elderly were use the Whole body vibration intervention during 10 minutes |
Who may qualify
- Ages
- 60 to 74 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- elderly between 60 to 74 years,
- sedentary according the International Physical Activity Questionnaire (IPAQ- short form)
- For diabetic group, were considered who those medical diagnoses of type II diabetes for at least 02 complete years, who had used only oral hypoglycemic agents of biguanides class (Metformin extended release - XR) in dosage between 500 to 850 mg.
- For healthy elderly group were considered elderly women without self-reported diseases
Key exclusion criteria (9 listed)
- diabetic volunteers who have ingested the breakfast less than 02 hours or more than 03 hours and those who have taken Metformin less than 02 hours before the intervention.
- the current or past smoking or alcoholic habits;
- the cardiovascular, liver or neuromuscular diseases;
- subjects with prior labyrinthitis or embolic events;
- who have had any surgery in last year;
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 |
|---|---|---|
| whole body vibrationwhole body vibration training on a vibrating platform with healthy elderly and diabetic elderly | Device | diabetic elderly, healthy elderly |
Primary outcome
Changes in glucose levels
Time frame: before and immediately after the 10 minute intervention
A digital puncture with disposable lancets was collected a peripheral blood drop in the specific strip for the home glucose monitoring AccuChek Active® (Roche Diagnostics GmbH, Mannheim, Germany) according to International Organization for Standardization (ISO) recommendations in 2013 (11).
Changes in lactate levels
Time frame: before and immediately after the 10 minute intervention
Another peripheral blood drop was collected from the same digital puncture with disposable lancets and put in the specific strip for to check the seric blood lactate, which was analyzed by a portable lactimeter Accutrend Plus ® (Roche Accutrend Plus, New York, USA).
3 secondary outcomes
peripheral oxygen saturation (SpO2)
Time frame: before and immediately after the 10 minute intervention
heart rate (HR)
Time frame: before and immediately after the 10 minute intervention
Borg's Rating of Perceived Exertion Scale (RPE) or Modified Borg Scale
Time frame: before and immediately after the 10 minute intervention
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 31 May 2018.
- Individual participant dataSharing planned: Undecided
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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 whole body vibration in people with Diabetes, run by Maíra F Pessoa at 1 site in Brazil.
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 9 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 31 May 2018. 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 Brazil. 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?
Changes in glucose levels (time frame: before and immediately after the 10 minute intervention). The study lists 2 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 31 May 2018.