An isolate from the leaves of Gymnema sylvestre, having
a specified molecular weight, is useful for the treatment of diabetes.
The isolate has a molecular weight at least about 3000 Daltons as determined
by molecular weight cut-off filtration. Glucose metabolism in a human patient
is regulated by dosage forms that contain the aforesaid isolate from the
leaves of Gymnema sylvestre, optionally in combination with a non-metabolizable
polysaccharide such as the exudate of Sterculia urens.
The concentration of glucose in the human bloodstream
must be controlled within a relatively tight range (60-120 milligrams per
deciliter of blood) to maintain normal health. If blood glucose drops too
low, a condition known as hypoglycemia results, with symptoms such as faintness,
weakness, headache, confusion and personality changes. Severe hypoglycemia
can progress to convulsions, coma and death. Excessive blood glucose, or
hyperglycemia, causes excess urine production, thirst, weight loss, fatigue,
and in the most severe cases, dehydration, coma and death. Chronic hyperglycemia
causes tissue damage due to the chemical reactions between the excess glucose
and proteins in cells, tissues, and organs. This damage is thought to cause
the diabetic complications of blindness, kidney failure, impotence, atherosclerosis,
and increased vulnerability to infection.
[0003] The pancreas makes hormones that regulate the concentration
of glucose in the blood. Insulin lowers blood glucose levels; when glucose
level rises after a meal, the pancreas secretes insulin, which causes muscle
and other tissues to take up glucose from the blood stream. Glucagon raises
blood glucose levels; when blood glucose levels fall, the pancreas secretes
glucagon to signal the liver to make stored glucose available.
[0004] A third glucose-regulating hormone, amylin, was
discovered in 1987. Physiologists now generally consider that all three
hormones play a role in the complex aspects of glucose metabolism. The
chemical structure of amylin and its metabolic action on muscle and pancreas
tissue has recently been elucidated. Amylin is said to work with insulin
to moderate the glucose-lowering effects of insulin under certain circumstances,
to help replenish liver glycogen after a meal, and to encourage the synthesis
of fat from excess glucose. As a result, amylin, like glucagon, can raise
the blood glucose level.
[0005] Diabetes mellitus is associated with continuous
and pathologically elevated blood glucose concentration; it is one of the
leading causes of death in the United States and is responsible for about
5% of all mortality. Diabetes is divided into two major sub-classes: Type
I, also known as juvenile diabetes, or Insulin-Dependent Diabetes Mellitus
(IDDM), and Type II, also known as adult onset diabetes, or Non-Insulin-Dependent
Diabetes Mellitus (NIDDM).
[0006] According to the American Diabetes Association,
there are over one million juvenile diabetics in the United States. Diabetes
is a form of autoimmune disease. Autoantibodies produced by the patients
completely or partially destroy the insulin producing cells of the pancreas.
Juvenile diabetics must, therefore, receive exogenous insulin during their
lifetime. Without treatment, excessive acidosis, dehydration, kidney damage,
and death may result. Even with treatment, complications such as blindness,
atherosclerosis, and impotence can occur.
[0007] There are more than five million Type II (adult
onset) diabetics diagnosed in the United States. Type II disease usually
begins during middle age; the exact cause is unknown. In Type II diabetics,
rising blood glucose levels after meals do not properly stimulate insulin
production by the pancreas. Additionally, peripheral tissues are generally
resistant to the effects of insulin. The resulting high blood glucose levels
(hyperglycemia) can cause extensive tissue damage. Type II diabetics are
often referred to as insulin resistant. They often have higher than normal
plasma insulin levels (hyperinsulinomia) as the body attempts to overcome
its insulin resistance. Some researchers now believe that hyperinsulinomia
may be a causative factor in the development of high blood pressure, high
levels of circulating low density lipo-proteins (LDLs), and lower than
normal levels of the beneficial high density lipo-proteins (HDLs). While
moderate insulin resistance can be compensated for in the early stages
of Type II diabetes by increased insulin secretion, in advanced disease
states insulin secretion is also impaired. Treatments of Type II diabetes
preferably address both insulin resistance and faulty insulin secretion.
[0008] Insulin resistance and hyperinsulinomia have also
been linked with two other metabolic disorders that pose considerable health
risks: impaired glucose tolerance and metabolic obesity. Impaired glucose
tolerance is characterized by normal glucose levels before eating, with
a tendency toward elevated levels (hyperglycemia) following a meal. According
to the World Health Organization, approximately 11% of the U.S. population
between the ages of 20 and 74 are estimated to have impaired glucose tolerance.
These individuals are considered to be at higher risk for diabetes and
coronary artery disease.
[0009] Obesity may also be associated with insulin resistance.
A causal linkage among obesity, impaired glucose tolerance, and Type II
diabetes has been proposed, but a physiological basis has not yet been
established. Some researchers believe that impaired glucose tolerance and
diabetes are clinically observed and diagnosed only later in the disease
process after a person has developed insulin resistance and hyperinsulinomia.
[0010] Insulin resistance is frequently associated with
hypertension, coronary artery disease (arteriosclerosis), and lactic acidosis,
as well as related disease states. The fundamental relationship between
these disease states, and a method of treatment, has not been established.
[0011] Insulin and sulfonylureas (oral hypoglycemia therapeutic
agents) are the two major classes of diabetes medicines prescribed today
in the United States. Insulin is prescribed for both Type I and Type II
diabetes, while sulfonylureas are usually prescribed for Type II diabetics
only. Sulfonylureas stimulate natural insulin secretion and reduce insulin
resistance; these compounds do not replace the function of insulin in metabolism.
Approximately one-third of patients who receive sulfonylurea become resistant
to it. Some Type II diabetics do not respond to sulonylurea therapy. Of
patients who do respond to initial treatment with sulfonylureas, 5-10%
are likely to experience a loss of sulfonylurea effectiveness after about
ten years.
[0012] Insulin itself has a relatively narrow therapeutic
window. Relatively high insulin doses can produce hypoglycemic shock as
the blood glucose drops too low. Low or infrequent doses may result in
hyperglycemia.
[0013] In Europe, two other classes of oral hypoglycemic
agents are available, i.e., biguanides and alpha-glucosidase inhibitors.
Biguanides work by reducing glucose production in the liver and limiting
glucose absorption. Although biguanides are also used in Canada, they are
banned in the U.S. due to increased incidence of mortality. Alpha-glucosidase
inhibitors are sold in certain European countries, but have not obtained
FDA approval for use in the U.S. These drugs reduce high blood glucose
levels by slowing the uptake of ingested foods. Side effects include flatulence,
diarrhea, and abdominal pain.
[0014] U.S. Pat. No. 4,761,286 to Hiji discloses that
an aqueous extract derived from the leaves of Gymnema sylvestre can be
utilized in combination with a foodstuff that is absorbed as glucose by
the intestinal tract so as to inhibit glucose absorption. Chatterji, International
Patent Application No. WO 95/10292, reported that glucose metabolism in
a human patient can be effectively modulated by oral administration of
an extract derived from the leaves of G. sylvestre in combination with
a bio-inert polysaccharide, i.e., a polysaccharide that is non-metabolizable
by the patient.
[0015] It has now been found, however, that glucose metabolism
in a human patient can be effectively modulated by oral administration
of a relatively high molecular weight isolate derived from the leaves of
G. sylvestre , optionally in combination with a non-metabolizable polysaccharide.
DIABET GUARD is a combination
of 16 herbs. Taken one tea spoon 30 minutes before
major meals - twice a day it reduces blood sugar levels and keeps
it well under control. DIABET GUARD absorbs excess
sugar in the blood like a blotting paper.
Taken
over a period of 4- 8 month the DIABET GUARD will have following effects:
-
It
will reverse/prevent/make mild the diabetic condition.
-
Stimulate
and regenerate the beta cells in Langerhans islets of the pancreas and
make it produce sufficient amount of quality insulin.
-
Make
the body naturally more sensitive to insulin.
When
the blood glucose levels goes beyond the normal range even for a single
hour some damage is done to the vital parts of the body like nerve endings,
kidneys, heart, eyes, teeth and reproductive system. DIABET GUARD will
eliminate that risk by absorbing the excess sugar like a blotting paper.
If you are in pre diabetes
or borderline diabetes stage there is a very high possibility that with
DG
you may never develop full blown diabetes. If you are already diagnosed
with full blown diabetes - DG herbals formulation will make the diabetic
condition extremely mild where no damage is done to the vital parts of
the body.
.
Order -
DIABET GUARD
Each bottle contains 100
grams of the anti diabetic herbal mix. One bottle will be for 10 days.
The price is U.S.$8/Bottle - you can see the results (glucose lowering
effect) within 4-5 days. We recommend trying at
least 3 bottles which will be for a month.
 U.S.$8/Bottle
(There is a one time charge
of U.S.$10/- towards Packing, Shipping and FDA documentation. This charge
is same even if 50 or even 100 bottles of DIABET GUARD are ordered)
Delivery
within 12 days from the date of ordering
Dosage: 5
grams - Twice a day - 15 minutes before the 2 major meals. |
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.
US
FDA DSHEA – 1994 Disclaimer
Diabetics
taking this Herbal formulation are advised to be under the
care of
an Authorized Doctor in their locality as they have been before .
The effect
of DIABET GUARD has not been evaluated by US FDA. DIABET
GUARD is
not intended to Diagnose/treat or cure any ailment .
Individual
results may vary. |