A single arm trial using passive simulated jogging for blunting acute hyperglycemia

Jose A Adams, Jose R Lopez, Veronica Banderas, Marvin A Sackner, Jose A Adams, Jose R Lopez, Veronica Banderas, Marvin A Sackner

Abstract

Glycemic fluctuations increase oxidative stress, promote endothelial dysfunction and cardiovascular disease. Reducing glycemic fluctuations is beneficial. We previously reported that a portable motorized passive simulated jogging device, (JD) reduces 24 h glycemic indices in type 2 and non-diabetic subjects. This study evaluates effectiveness and feasibility of JD in blunting large glycemic fluctuation induced by an oral glucose tolerance test (OGTT). The study was performed in 10 adult participants mean age 41.3 ± 13.5 year using interstitial glucose monitor (IG). Each participant fasted for 8 h. followed by an OGTT (Pre-JD), thereafter JD was used for 90 min per day for 7 days, without change to diet or activities of daily living. A repeat OGTT (Post-JD) was performed after completion. The integrated area under the curve (iAUC2h-4h) was computed for the OGTT Pre-JD and Post-JD. Seven days of JD blunted the glucose fluctuation produced by OGTT. JD decreased AUC2h by 17 ± 4.7% and iAUC4h by 15 ± 5.9% (p < 0.03). In healthy mostly obese participants 7 days of JD blunts the hyperglycemic response produced by an OGTT. JD may be an adjunct to current glycemic management, it can be applied in different postures for those who cannot (due to physical or cognitive limitations) or will not exercise.Trial registration: ClinicalTrials.gov NCT03550105 (08-06-2018).

Conflict of interest statement

JAA performs research for Sackner Wellness Products LLC and is a US co-patent holder for Gentle Jogger, the Passive Simulated Jogging Device. JRL is a Research Scientist consultant with Sackner Wellness Products LLC. VB is a part time study coordinator and employee of Sackner Wellness Products LLC. MAS is President of Sackner Wellness Products LLC and Is a US co-patent holder for Gentle Jogger the Passive Simulated Jogging Device.

Figures

Figure 1
Figure 1
Study protocol. Continuous glucose monitor (CGM) was applied to the non-dominant arm on entering in the study (Day 0). Participants were asked to fast for 8 h prior to the initial baseline oral glucose tolerance test (OGTT) pre passive simulated jogging device (Pre-JD) on Day 2. During the visit participants were instructed on the use of JD. Participants were asked to use JD a minimum of 3 times for 30 min per day for 7 days from day 3 to 9. The evening of day 9 participants were asked to stop use of JD and fast for 8 h. On day 10 a repeat OGTT was performed Post-JD.
Figure 2
Figure 2
Oral glucose tolerance curves pre and post passive simulated jogging device. Representative 4 h Oral Glucose Tolerance Curves (OGTT) before (Pre-JD) and after 7 days of JD use (Post-JD) from two participants A, B.
Figure 3
Figure 3
Mean curves and integrated area under the curve of the 2 and 4 h oral glucose tolerance test. Mean and standard deviation for each time point of the 2 h (A) and 4 h (B) Oral Glucose Tolerance Test (OGTT), before (Pre-JD) and after (Post-JD) 7 days of passive simulated jogging (JD). Mean and standard deviation for the Integrated Area Under Curve (iAUC) of the 2 h (C) and 4 h (D) OGTT for each subject, before (Pre-JD) and after 7 days of JD use (Post-JD) (*p < 0.005 Pre-JD vs Post-JD).
Figure 4
Figure 4
Passive Jogging Device (JD) increases Nitric Oxide (NO) Bioavailability. (A) Representative Plethysmographic arterial pulse waveform at baseline denoting the position of the dicrotic notch and the a and b position on the pulse waveform. (B) representative tracings of one subjects descent of the dicrotic notch at baseline and during use of JD device (C) JD in seated posture increased a/b ratio 24-fold from baseline values, confirming that JD increases NO bioavailability in human subjects. (***p < 0.001 Baseline vs. JD) [MEAN (SD)].

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