- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT03550105
Effects of Simulated Passive Jogging Device on Glucose Homeostasis, Muscle Strength and Endurance
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Florida
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Miami, Florida, Forente stater, 33136
- CIC Miami
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- 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
Exclusion Criteria:
- Younger than 25 yrs or Older than 80 yrs
- Unable to provide consent
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: GJ-Only
Study Subjects with Baseline Glucose of > 150mg/dl, will have Gentle Jogger Only for 7 days
|
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
|
Eksperimentell: GJ-OGTT
Study Subjects with Baseline Glucose of < 150mg/dl, will have Oral Glucose Tolerance Test (OGTT) at baseline and after 7 days of Gentle Jogger
|
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
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Glycemic Control
Tidsramme: 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
|
8 days
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Variability of Glycemic Control - (24 hrs Standard Deviation of Glycemia)
Tidsramme: 8 Days
|
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)
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8 Days
|
Muscle Strength
Tidsramme: 8 days
|
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
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8 days
|
Muscle Endurance
Tidsramme: 8 days
|
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
|
8 days
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Carry Over Effect of Muscle Strength
Tidsramme: 14 days
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For BOTH Groups: Comparison of grip force between last day of GJ and day 14 ( 3 days after completion of GJ)
|
14 days
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Carry Over Effect of Muscle Endurance
Tidsramme: 14 days
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For BOTH Groups: Comparison of muscle strength between last day of GJ and day 14 ( 3 days after completion of GJ)
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14 days
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Samarbeidspartnere og etterforskere
Sponsor
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
- Adams 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.
- Adams 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.
- Adams 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.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- GJHP03122018
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