Diabetes MellitusNCT03550105
Effects of Simulated Passive Jogging Device on Glucose Homeostasis, Muscle Strength and Endurance
A study testing Gentle Jogger in people with Diabetes Mellitus and Glucose Metabolism Disorders, run by Sackner Wellness Products LLC at 1 site in United States.
Trial summary
Physical Inactivity and excessive sedentary behavior are risk factors for diabetes and cardiovascular disease. Movement is important for overall health. This study will assess the validity and usefulness of low risk, non-invasive wellness device, the Gentle Jogger® (GJ) that passively simulates the physical activities… Read more about this study
- Who is it for?
- Ages 25 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Glucose Metabolism Disorders, Physical Activity
- What is being tested?
- Gentle Jogger
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jun 2018to 23 Jan 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 25 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteers able to consent ages 25-80yrs
- Known Diabetics (Type 1 or Type 2)- Previously diagnosed by their physician on either Insulin and or oral diabetic medications ages 25-80yrs
Who cannot join
- Younger than 25 yrs or Older than 80 yrs
- Unable to provide consent
Trial locations and contacts
1 site in 1 country.
About this study
Physical Inactivity and excessive sedentary behavior are risk factors for diabetes and cardiovascular disease. Movement is important for overall health. This study will assess the validity and usefulness of low risk, non-invasive wellness device, the Gentle Jogger® (GJ) that passively simulates the physical activities of jogging. The study will evaluate whether or not use of GJ modifies glycemic control and muscle strength in subjects who are known to be diabetic and those who are not. The study volunteers are subjects between the ages of 25-80yr.
Read the detailed description
Excessive sedentary behavior and physical inactivity are independent risk factors for; obesity, metabolic syndrome, heart disease, Type 2 Diabetes Mellitus (T2DM), and hypertension. In adults with T2DMT interrupting prolonged sitting improves glycemic control. Increasing physical activity even briefly (3-15 min) is effective in reducing postprandial hyperglycemia and improving glycemic control. To address the excessive sedentary behavior Sackner Wellness Products has patented a non-invasive method for inducing passive movement while in seated or supine posture the Gentle Jogger® (GJ)which simulates the activities of jogging. Passive simulation of jogging introduces pulses into the circulation as the foot strikes the device. These pulsations have been shown to elicit production of beneficial mediators which are important to cardiovascular health. The study will recruit two groups of subjects ages 25-80. One group (n=45) of either sex who are not known to be diabetics and have a normal fasting glucose. Another group (n=45) who are known to be diabetics (Type 1 or Type 2) previously diagnosed by their physician and currently on insulin and or oral medications. Exclusion criteria are those younger than 25yrs and greater than 80yrs, and inability to provide informed consent. The study will last 14 days total and will consist of 5 study visit days. Volunteers will be paid for their participation in the study.
On day 1 participants will have a continuous interstitial glucose sensor ( Freestyle Libre Pro), and an activity monitor placed. The participants will have their blood pressure measured and muscle strength and endurance measured using a dynamometer which measures grip force. Based on the average glucose obtained on day 1-2 of the study, subjects will be assigned to two groups. A) GJ-Only (subjects with baseline average glucose of > 150mg/dl or B) GJ with Oral Glucose Tolerance Testing(GJ-OGTT) (subjects with baseline average glucose of < 150mg/dl).
On day 3 those enrolled in GJ-OGTT groups will have a basal oral glucose tolerance test and grip force and blood pressure will be measure before and after the OGTT. Those enrolled in GJ -Only group will only have grip force and blood pressure measured. Day 4 of the study all subjects will be instructed on the use of GJ device and will be asked to use the device 3 times per day for 30 min, from day 4 till day 11. On day 11 those enrolled in GJ-OGTT groups will have a repeat oral glucose tolerance test , grip force and blood pressure will be measure before and after the OGTT. Those enrolled in GJ -Only group will only have grip force and blood pressure measured. On day 14 all subjects will have grip force and blood pressure measured and a brief debriefing about their experience with GJ.
The total days enrolled in the study are14 days.
The Gentle Jogger's intended use as a wellness device in which , 1) GJogger are part of a healthy lifestyle, which may help to reduce the risk of certain chronic diseases or conditions such as heart disease, high blood pressure, and type 2 diabetes and, 2) may help living well with certain chronic diseases or conditions such as s heart disease, high blood pressure, and type 2 diabetes.
- Being tested
- Gentle Jogger
- Keywords
- Glucose, Diabetes, Physical Activity, Passive Exercise, Blood Pressure, Muscle Strength, Muscle Endurance, Hypertension, Physical Inactivity
- Medical subject headings
- Diabetes Mellitus, Glucose Metabolism Disorders, Motor Activity, Hypertension, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gentle JoggerDevice
Gentle Jogger is a passive simulated jogging device to be used 3 times per day for at least 30 mins for 7 days in this study
| Study group | Role | What they receive |
|---|---|---|
| GJ-Only | Experimental | Study Subjects with Baseline Glucose of > 150mg/dl, will have Gentle Jogger Only for 7 days Receives: Device: Gentle Jogger |
| GJ-OGTT | Experimental | Study Subjects with Baseline Glucose of < 150mg/dl, will have Oral Glucose Tolerance Test (OGTT) at baseline and after 7 days of Gentle Jogger Receives: Device: Gentle Jogger |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemic Control
For GJ-OGTT Group: Blunting of the peak and decrease of the area under the curve of the Oral Glucose Tolerance after 7 days of Gentle Jogger For GJ-Only Blunting or decreased of basal glucose levels ( 3 days prior to GJ) compared to glucose levels after 7 days of GJ
Measured: 8 days
Secondary outcomes (5)
Variability of Glycemic Control - (24 hrs Standard Deviation of Glycemia)
Comparison of 24 hrs of Glycemic variability at 3 time periods a)24 hrs before GJ b) the last 24 hrs of GJ and c) Last 24 hrs of study ( day 13-14)
Measured: 8 Days
Muscle Strength
For GJ-OGTT Group: improved grip force after 7 days of GJ Compared to prior to GJ For GJ-Only improved grip force after 7 days of GJ Compared to prior to GJ
Measured: 8 days
Muscle Endurance
For GJ-OGTT Group: improved grip endurance after 7 days of GJ Compared to prior to GJ For GJ-Only improved grip force and endurance after 7 days of GJ Compared to prior to GJ
Measured: 8 days
Carry Over Effect of Muscle Strength
For BOTH Groups: Comparison of grip force between last day of GJ and day 14 ( 3 days after completion of GJ)
Measured: 14 days
Carry Over Effect of Muscle Endurance
For BOTH Groups: Comparison of muscle strength between last day of GJ and day 14 ( 3 days after completion of GJ)
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2018
- Study start5 Jun 2018
- Primary completion23 Jan 2020
- Study completion23 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- A) Study Subjects with Baseline Glucose of \> 150mg/dl, will have Gentle Jogger Only for 7 days B) Study Subjects with Baseline Glucose of \< 150 mg/dl will have basal oral glucose tolerance test (OGTT) and repeat OGTT after 7 days of Gentle Jogger
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sackner Wellness Products LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03550105
- Sponsor's protocol ID
- GJHP03122018
- Status last verified
- Apr 2019
- First submitted
- 1 May 2018
- Last updated
- 27 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Adams JA, Lopez JR, Nadkarni V, Zolkipli-Cunningham Z, Ischiropoulos H, Sackner MA. The effects of a motorized passive simulated jogging device on descent of the arterial pulse waveform dicrotic notch: A single arm placebo-controlled cross-over trial. Physiol Rep. 2022 Aug;10(15):e15418. doi: 10.14814/phy2.15418.
PubMed 35924333Adams JA, Lopez JR, Banderas V, Sackner MA. The Effects of Passive Simulated Jogging on Parameters of Explosive Handgrip in Nondiabetics and Type 2 Diabetics: A Single Arm Study. Biomed Res Int. 2022 Feb 11;2022:6450844. doi: 10.1155/2022/6450844. eCollection 2022.
PubMed 35187168Adams JA, Lopez JR, Banderas V, Sackner MA. A single arm trial using passive simulated jogging for blunting acute hyperglycemia. Sci Rep. 2021 Mar 19;11(1):6437. doi: 10.1038/s41598-021-85579-7.
PubMed 33742027Adams JA, Banderas V, Lopez JR, Sackner MA. Portable Gentle Jogger Improves Glycemic Indices in Type 2 Diabetic and Healthy Subjects Living at Home: A Pilot Study. J Diabetes Res. 2020 Jan 21;2020:8317973. doi: 10.1155/2020/8317973. eCollection 2020.
PubMed 32215273
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Simulated Passive Jogging Device on Glucose Homeostasis, Muscle Strength and Endurance
- ClinicalTrials.gov ID
- NCT03550105
- Acronym / sponsor ID
- GJHP03122018
- Keywords
- Glucose, Diabetes, Physical Activity, Passive Exercise, Blood Pressure, Muscle Strength, Muscle Endurance, Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Sackner Wellness Products LLCIndustry (pharma, biotech, devices)
- Study start
- 5 Jun 2018 (actual)
- Primary completion
- 23 Jan 2020 (actual)
- Study completion
- 23 Jan 2020 (actual)
- First posted
- 8 Jun 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.
Physical Inactivity and excessive sedentary behavior are risk factors for diabetes and cardiovascular disease. Movement is important for overall health. This study will assess the validity and usefulness of low risk, non-invasive wellness device, the Gentle Jogger® (GJ) that passively simulates the physical activities of jogging. The study will evaluate whether or not use of GJ modifies glycemic control and muscle strength in subjects who are known to be diabetic and those who are not. The study volunteers are subjects between the ages of 25-80yr.
Detailed description
Excessive sedentary behavior and physical inactivity are independent risk factors for; obesity, metabolic syndrome, heart disease, Type 2 Diabetes Mellitus (T2DM), and hypertension. In adults with T2DMT interrupting prolonged sitting improves glycemic control. Increasing physical activity even briefly (3-15 min) is effective in reducing postprandial hyperglycemia and improving glycemic control. To address the excessive sedentary behavior Sackner Wellness Products has patented a non-invasive method for inducing passive movement while in seated or supine posture the Gentle Jogger® (GJ)which simulates the activities of jogging. Passive simulation of jogging introduces pulses into the circulation as the foot strikes the device. These pulsations have been shown to elicit production of beneficial mediators which are important to cardiovascular health. The study will recruit two groups of subjects ages 25-80. One group (n=45) of either sex who are not known to be diabetics and have a normal fasting glucose. Another group (n=45) who are known to be diabetics (Type 1 or Type 2) previously diagnosed by their physician and currently on insulin and or oral medications. Exclusion criteria are those younger than 25yrs and greater than 80yrs, and inability to provide informed consent. The study will last 14 days total and will consist of 5 study visit days. Volunteers will be paid for their participation in the study.
On day 1 participants will have a continuous interstitial glucose sensor ( Freestyle Libre Pro), and an activity monitor placed. The participants will have their blood pressure measured and muscle strength and endurance measured using a dynamometer which measures grip force. Based on the average glucose obtained on day 1-2 of the study, subjects will be assigned to two groups. A) GJ-Only (subjects with baseline average glucose of > 150mg/dl or B) GJ with Oral Glucose Tolerance Testing(GJ-OGTT) (subjects with baseline average glucose of < 150mg/dl).
On day 3 those enrolled in GJ-OGTT groups will have a basal oral glucose tolerance test and grip force and blood pressure will be measure before and after the OGTT. Those enrolled in GJ -Only group will only have grip force and blood pressure measured. Day 4 of the study all subjects will be instructed on the use of GJ device and will be asked to use the device 3 times per day for 30 min, from day 4 till day 11. On day 11 those enrolled in GJ-OGTT groups will have a repeat oral glucose tolerance test , grip force and blood pressure will be measure before and after the OGTT. Those enrolled in GJ -Only group will only have grip force and blood pressure measured. On day 14 all subjects will have grip force and blood pressure measured and a brief debriefing about their experience with GJ.
The total days enrolled in the study are14 days.
The Gentle Jogger's intended use as a wellness device in which , 1) GJogger are part of a healthy lifestyle, which may help to reduce the risk of certain chronic diseases or conditions such as heart disease, high blood pressure, and type 2 diabetes and, 2) may help living well with certain chronic diseases or conditions such as s heart disease, high blood pressure, and type 2 diabetes.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A) Study Subjects with Baseline Glucose of > 150mg/dl, will have Gentle Jogger Only for 7 days B) Study Subjects with Baseline Glucose of < 150 mg/dl will have basal oral glucose tolerance test (OGTT) and repeat OGTT after 7 days of Gentle Jogger
| Arm | Type | Receives |
|---|---|---|
| GJ-Only | Experimental | Device: Gentle JoggerStudy Subjects with Baseline Glucose of > 150mg/dl, will have Gentle Jogger Only for 7 days |
| GJ-OGTT | Experimental | Device: Gentle JoggerStudy Subjects with Baseline Glucose of < 150mg/dl, will have Oral Glucose Tolerance Test (OGTT) at baseline and after 7 days of Gentle Jogger |
Who may qualify
- Ages
- 25 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy volunteers able to consent ages 25-80yrs
- Known Diabetics (Type 1 or Type 2)- Previously diagnosed by their physician on either Insulin and or oral diabetic medications ages 25-80yrs
Key exclusion criteria (2 listed)
- Younger than 25 yrs or Older than 80 yrs
- Unable to provide consent
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 |
|---|---|---|
| Gentle JoggerGentle Jogger is a passive simulated jogging device to be used 3 times per day for at least 30 mins for 7 days in this study | Device | GJ-OGTT, GJ-Only |
Primary outcome
Glycemic Control
Time frame: 8 days
For GJ-OGTT Group: Blunting of the peak and decrease of the area under the curve of the Oral Glucose Tolerance after 7 days of Gentle Jogger For GJ-Only Blunting or decreased of basal glucose levels ( 3 days prior to GJ) compared to glucose levels after 7 days of GJ
5 secondary outcomes
Variability of Glycemic Control - (24 hrs Standard Deviation of Glycemia)
Time frame: 8 Days
Muscle Strength
Time frame: 8 days
Muscle Endurance
Time frame: 8 days
Carry Over Effect of Muscle Strength
Time frame: 14 days
Carry Over Effect of Muscle Endurance
Time frame: 14 days
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 27 Jan 2020.
- Derived from this study: PubMed 35924333Adams JA, Lopez JR, Nadkarni V, Zolkipli-Cunningham Z, Ischiropoulos H, Sackner MA. The effects of a motorized passive simulated jogging device on descent of the arterial pulse waveform dicrotic notch: A single arm placebo-controlled cross-over trial. Physiol Rep. 2022 Aug;10(15):e15418. doi: 10.14814/phy2.15418.
- Derived from this study: PubMed 35187168Adams JA, Lopez JR, Banderas V, Sackner MA. The Effects of Passive Simulated Jogging on Parameters of Explosive Handgrip in Nondiabetics and Type 2 Diabetics: A Single Arm Study. Biomed Res Int. 2022 Feb 11;2022:6450844. doi: 10.1155/2022/6450844. eCollection 2022.
- Derived from this study: PubMed 33742027Adams JA, Lopez JR, Banderas V, Sackner MA. A single arm trial using passive simulated jogging for blunting acute hyperglycemia. Sci Rep. 2021 Mar 19;11(1):6437. doi: 10.1038/s41598-021-85579-7.
- Derived from this study: PubMed 32215273Adams JA, Banderas V, Lopez JR, Sackner MA. Portable Gentle Jogger Improves Glycemic Indices in Type 2 Diabetic and Healthy Subjects Living at Home: A Pilot Study. J Diabetes Res. 2020 Jan 21;2020:8317973. doi: 10.1155/2020/8317973. eCollection 2020.
- 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.
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 Gentle Jogger in people with Diabetes Mellitus and Glucose Metabolism Disorders, run by Sackner Wellness Products LLC at 1 site in United States.
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 2 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 27 Jan 2020. 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 United States. 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?
Glycemic Control (time frame: 8 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03550105, which also lists 4 linked publications.
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 27 Jan 2020; AzTrials last refreshed its copy on 7 Nov 2026.