Diabetes Mellitus Clinical Trial
Official title:
Effects of Simulated Passive Jogging Device on Glucose Homeostasis, Muscle Strength and Endurance
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.
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.
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