1. To determine the reliability and performance of the Dexcom G6® continuous glucose
monitoring (CGM) system in patients with diabetes undergoing hyperbaric oxygen (HBO2)
exposure. The study-specific blood glucose meter and CGM system are approved by the FDA
(U.S. Food and Drug Administration).
2. To determine whether HBO2 exposure causes blood glucose to drop as a result of the
treatment.
3. To determine whether HBO2 causes a change in blood glucagon (a hormone that raises blood
glucose).
Investigators will be comparing changes in blood glucose and glucagon in volunteers with
diabetes who will be exposed to a single hyperbaric oxygen treatment (pressurization to 2.4
atmospheres absolute for 90 minutes) to a control period of 2 hours where volunteers will
simulate a hyperbaric treatment while sitting in an examination room breathing room air at
sea level pressure. Investigators will be measuring blood glucose with a variety of devices
including a continuous glucose monitor, two point-of-care glucometers, and the hospital
inpatient laboratory measurement of venous blood.
This study evaluates the effect of additional hyperbaric oxygen therapy after lower extremity
amputation. The patients will be randomized after amputation to either a treatment group
receiving hyperbaric oxygen therapy, or control group.
In a recent series of studies performed by our group, we have shown that exposure to
hyperbaric oxygen (HBO) leads to an increase in insulin sensitivity in male subjects with
type-2 diabetes (T2DM) and in obese and overweight men without diabetes. The aim of this
study is to investigate the relationship between pressure and oxygen in producing this
effect, specifically, is this effect measurable in hyperbaric air or is some higher pressure
of oxygen required?
Aims:
1. To determine whether the insulin sensitising effect of HBO is apparent in hyperbaric air
at the same pressure as HBO.
2. To examine mechanisms underpinning the increase in insulin sensitivity following HBO.
An urgent need exists to identify effective interventions to arrest or reverse dementia and
cognitive loss at its earliest stages. The proposed pilot randomized clinical trial will
investigate the short and long-term effects of hyperbaric oxygen therapy on cognitive
functioning, cerebral blood flow, and glucose uptake in diabetic elderly with mild cognitive
impairment. and provide the basis for a large-scale multi-center study of hyperbaric oxygen
therapy effects on cognition in diabetes. The potential to preserve, or even enhance,
cognition in elderly at high risk of cognitive decline and dementia has major implications
for the affected individuals and their support systems that bear the social and financial
burdens of long-term caregiving.
Hyperbaric oxygenation (HBO) involves breathing of 100% oxygen under elevated ambient
pressure. In correlation to the pressure level oxygen dissolves in the plasma resulting in an
increase of total oxygen in the body. The elevated tissue levels of oxygen may persist for
hours, instigating healing processes in wounds caused by disturbances in of perfusion in
small vessels, a condition often found in patient with diabetes.
We plan a prospective, double-blind randomized clinical study in 80 patients with chronic
diabetic ulcer. All will have optimum treatment of diabetes. The HBO group will be given HBO
at 2.4 bar, 90 min., 30 sessions, controls will have sham HBO. Routine wound care will be
identical in both groups. Before, during and after treatment (3, 6 and 12 months), a number
of monitoring and imaging procedures will be done, cells in the bloodstream indicating
improved healing will be determined.
Hypothesis: HBO will instigate the healing process in the majority of patients with chronic
diabetic leg ulcer, provided the patency of the large vessels is given.
The purpose of this study is to determine if HBOT plus standard wound care is more effective
than standard wound care alone at preventing the need for major amputation (metatarsal and
up) in patients with diabetes mellitus (Type 1 or 2) with moderate to sever chronic wounds of
lower limbs.
