Stanford University and Veterans Affairs Researchers Demonstrate Significant Glucose Reduction in Study of CVAC Process for Insulin Resistance and Diabetes
PALO ALTO, CA -- (Marketwire) -- 08/07/08 -- The Stanford University Center on Longevity
and the U.S. Department of Veterans Affairs Palo Alto Health Care System
(VAPAHCS) today announced positive data from their 10-week study of the
Cyclic Variations in Altitude Conditioning(TM) (CVAC(TM)) process, CVAC
Systems Inc.'s new modality being researched for insulin resistance and
diabetes. The blinded, controlled clinical trial, which exposed subjects
to the CVAC process for 40 minutes, three times a week for 10 weeks, found
that the subject group receiving active CVAC exposure demonstrated a
significant reduction in fasting blood glucose and a significant decrease
in blood glucose during an oral glucose tolerance test (OGTT) following the
10 weeks of exposure. There was no significant change in the control
group. No significant safety concerns were observed during the study.
"The data from this study are very promising and suggest that CVAC could
provide a unique way to lower blood glucose levels in certain individuals,"
said principal investigator Dr. Anne Friedlander, Director of the Major
Project on Mobility at the Stanford Center on Longevity and a VAPAHCS
research scientist. "Given that these positive results were achieved in
middle-aged, non-diabetic volunteers, we are hopeful that CVAC will prove
even more effective in diabetic subjects with higher initial fasting
glucose levels. These data are consistent with our understanding of the
mechanism by which hypoxia (or low oxygen levels) could impact glucose
metabolism."
The study was conducted at VAPAHCS by Stanford and VA researchers. The
study enrolled 21 healthy male subjects between the ages of 40 and 60.
Fasting glucose levels were reduced from a baseline average reading of 96
to 90 mg/dl in the CVAC group (p < 0.05), while fasting glucose increased
from 94 to 97 mg/dl in the control group. In addition, the change in OGTT
area-under-the-curve values for blood glucose were significantly reduced in
the CVAC group relative to the control group (p < 0.03). Dr. Friedlander
has submitted an abstract describing the study and the data for
presentation at the 6th Annual World Congress on the Insulin Resistance
Syndrome to be held September 25-27, 2008 at the Hilton, Universal City,
Los Angeles, CA.
"While we expect outstanding results from the application of CVAC in
diabetes, our next clinical trial is in diabetic neuropathy," said Allen
Ruszkowski, president and CEO of CVAC Systems, Inc. "Diabetic neuropathy
afflicts 70 percent of the Type 2 diabetics in the US, with two-million
patients displaying symptomatic neuropathy, which is often an extremely
painful condition with no effective treatment. Furthermore, diabetic
neuropathy is associated with more than 1000 amputations per week in the
US, demonstrating a large, unmet clinical need for an effective therapy.
Based on preliminary studies, we expect CVAC will do much more than
alleviate pain. We expect the planned course of clinical studies to show
that regular, long-term CVAC use restores the health and function of the
damaged tissues in addition to alleviating pain."
The clinical protocol for the diabetic neuropathy trial was approved by the
Stanford University Human Studies Review Board.
"We are excited about the potential for the CVAC process to produce an
improvement in both the condition and quality of life for diabetes and
diabetic neuropathy patients," added Dr. Friedlander. "We are still
researching the mechanism, but if use of CVAC attenuates insulin
resistance, it is possible that CVAC could also be useful in treating other
disorders related to insulin resistance and the aging process."
The CVAC Process: A New Modality for the Mitigation of Insulin Resistance,
Diabetes, and Related Conditions
The patent-pending CVAC process for the treatment of insulin resistance,
diabetes, and related conditions involves the use of an altitude simulator
in which users sit and are exposed to various levels of atmospheric
pressure. Evidence exists that such changes in pressure levels, when
combined with the intermittent hypoxia that occurs as a result of reduced
atmospheric pressure, increase cellular mitochondrial density, nitric oxide
concentrations and glucose transfer proteins. Such cellular level changes
may explain the effectiveness of the CVAC process in reducing glucose
levels.
About the Stanford Center on Longevity
The goal of the Stanford Center on Longevity (SCL) is to transform the
culture of aging by combining scientific and technological discoveries with
swift entrepreneurial action. The SCL links top scholars in their fields
with government, business and the media to focus on practical solutions to
assure that people arrive in their later years physically fit, mentally
sharp, and financially secure.
About the U.S. Department of Veterans Affairs Palo Alto Health Care System
The U.S. Department of Veterans Affairs Palo Alto Health Care System is a
teaching hospital, providing a full range of patient care services, with
state-of-the-art technology, as well as education and research. VAPAHCS
has 897 operating beds, including a 300-bed hospital, three nursing homes
and a 100-bed homeless domiciliary. VAPAHCS is home to a variety of
regional treatment centers, including a Spinal Cord Injury Center, a
Polytrauma Rehabilitation Center, the Western Blind Rehabilitation Center,
a Geriatric Research, Educational and Clinical Center, a Homeless Veterans
Rehabilitation program and the National Center for PTSD. It also supports
the third largest research program in the VA.
About CVAC Systems, Inc.
CVAC Systems, Inc. is a privately held medical device company headquartered
in Temecula, CA focused on the application of its Cyclic Variations in
Altitude Conditioning process to diseases and disorders associated with
aging, including insulin resistance, diabetes, neuropathy, cardiovascular
disease, Alzheimer's and declining testosterone levels. In addition to
these medical applications, the company has scientific validation of the
effectiveness of the CVAC process at improving physical performance and is
developing studies to demonstrate improvements in cognitive ability. The
company is currently partnered with revenue-producing sites in California,
Arizona, and New Mexico for improving fitness and is seeking to place CVAC
systems at key luminary research sites for the development of several
patent-pending applications such as performance enhancement, disease
prevention, therapy and advanced health. The company is also currently in
discussions with potential partners for applications in executive health
and wellness.
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