Method of treating insulin resistance, adult onset diabetes and metabolic syndrome x

a technology of metabolic syndrome and insulin resistance, applied in the field of treating insulin resistance, adult onset diabetes, metabolic syndrome x, can solve the problems of patient's blood sugar level often rising gradually, blood sugar level rising above the safety level, and body breaking down fat stores for energy, etc., to reduce the absorption of vitamin b12, reduce the risk of cardiac events, and reduce the effect of absorption

Inactive Publication Date: 2005-12-29
KURTZ SEYMOUR J
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0034] Although drug therapy has proven to be effective in reducing and treating insulin resistance, adult onset diabetes, and MS-X and its related complications, it leads to side effects, such as weight gain, water retention, slight risk of cardiac events and hypoglycemia, gastrointestinal problems including nausea, flatulence, and diarrhea, lactic acidosis, reduced absorption of vitamin B12 and folic acid, and reduced iron absorption.
[0035] Accordingly, there is a need to provide an improved method of treating the above-mentioned conditions that avoids or minimizes these side effects. There is a continuing need to provide an early method for treating these conditions to avoid the emergence of costly and disabling degenerative conditions, as described above.
[0036] The present invention is based on the discovery that treatment of mammalian subjects with intravenously administered liposomes of the type described herein results in a reduction of insulin resistance and improvement of symptoms of adult onset diabetes, and metabolic syndrome X and its related complications, with negligible or no side effects.

Problems solved by technology

Diabetes or diabetes mellitus is a disease that occurs when the body cannot make use of the glucose in the blood for energy because either the pancreas is not able to make enough insulin or the insulin that is available is not effective.
If the level of insulin is too low for a long period of time, the body begins to break down its stores of fat for energy.
This causes the body to release fatty acids which are then converted into ketone bodies or ketoacids that are toxic at high levels.
Because insulin is not available or is improperly used, the blood sugar level rises above the safety level.
The patient's blood sugar level often rises gradually, taking several years to reach unsafe levels and cause symptoms.
Over time however, insulin production often drops and resistance worsens.
However, the possible adverse effects of insulin on weight gain and the heart are troublesome.
However, when grouped together, they are increasingly atherogenic and enhance the risk of cardiovascular disease (CVD) at any low density lipoprotein cholesterol level.
Overproduction of insulin leads to hypertension.
Increased blood pressure independently increases the risk of atherosclerosis, presumably by promoting the entry of LDL into the subendothelial space, and may exacerbate other metabolic abnormalities.
Although drug therapy has proven to be effective in reducing and treating insulin resistance, adult onset diabetes, and MS-X and its related complications, it leads to side effects, such as weight gain, water retention, slight risk of cardiac events and hypoglycemia, gastrointestinal problems including nausea, flatulence, and diarrhea, lactic acidosis, reduced absorption of vitamin B12 and folic acid, and reduced iron absorption.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

example 1

Preparation of Small Unilamellar Vesicles by Sonication

[0095] Egg PC dissolved in chloroform was placed in a 100 ml vessel and dried to a thin film under an inert atmosphere of nitrogen. Sterile saline was added to the lipid film to a final concentration of about 100 mg / ml, and the lipid film was hydrated with swirling. The resulting multilamellar vesicle (MLV) suspension was then bath sonicated for 1 hour using a Heat System Sonicator, Model 375W, at a power setting of 40-50% full value. The temperature of the suspension was maintained at about 4° C. during sonication. Large vesicles or MLVs were separated from the sonicated suspension by ultracentrifugation at 100,000 g for 1 hour (Barenholz, Y. et al., Biochemistry (1977) 16:2806). The remaining suspension of SUVs, having a concentration of about 100 mg / ml, was then filter sterilized.

example 2

Preparation of Small Unilamellar Vesicles by Extrusion

[0096] Homogeneous small unilamellar vesicles (SUVs) of egg PC for human use with an average diameter of 65 nm±10 nm in size, in 0.15M NaCl, were prepared by extrusion using serial filtration through polycarbonate filters in a GH 76-400 pressure cell (Nucleopore) (Anselem, S., et al. In Gregoriadis, G. (ed). LIPOSOME TECHNOLOGY, pp. 501-524, CRC Press, Boca Raton, Fla. (1993)). These vesicles were empty SUVs.

[0097] Liposomal particle size was measured by Nicomp submicron laser particle sizer, by Quasielectric light scattering or comparable method. It can also be determined using a Coulter model N4 sub-micron particle analyzer equipped with a size distribution processor analyzer (Barenholz et al. In Gregoriadis, G. (ed), LIPOSOME TECHNOLOGY, pp. 524-607, CRC Press, Boca Raton, Fla. (1993)). The final extrusion step was through a 0.05 micrometer pore polycarbonate filter. Egg PC SUV's should be sterile and pyrogen-free and were s...

example 3

Alternative Preparation of Small Unilamellar Vesicles by Extrusion

[0112] Homogeneous small unilamellar vesicles (SUVs) of egg PC for human use with an average diameter of 60 nm±5 nm in size, were prepared by extrusion using filtration through polycarbonate membrane filters using an Aviston EmulsiFlex-C50 homogenizer with Supor Cap™ and SuporDCF™ serial layer disposable filters (220 nm, 180 nm and 80 nm). These vesicles were empty SUVs.

[0113] Liposomal particle size was measured by Solvias AG, Basel, Switzerland submicron laser particle sizer, by Quasielectric light scattering or comparable method. It can also be determined using a Coulter model N4 sub-micron particle analyzer equipped with a size distribution processor analyzer (Barenholz et al. In Gregoriadis, G. (ed), LIPOSOME TECHNOLOGY, pp. 524-607, CRC Press, Boca Raton, Fla. (1993)). The final extrusion step was through a 0.08 μm pore polycarbonate membrane filter. Egg PC SUv's should be sterile, endotoxin (LAL)-free and pyr...

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Abstract

A method of treating insulin resistance, adult onset diabetes, and metabolic syndrome X and its related complications, in mammalian subject is accomplished by intravenously administering to a mammalian subject, a therapeutically effective amount of a liposomal suspension of lipoprotein small unilamellar vesicles (SUVs) comprising predominantly phospholipids. The liposomal suspension is administered over a period of time, whereby in the levels of some or all of blood glucose, insulin, total cholesterol, LDL cholesterol, triglyceride, creatine kinase (CK), creatine kinase-MB (CK-MB), Hb-A1c, lipoprotein (a), SGOT and SGPT fall back within the normal range or are significantly reduced.

Description

FIELD OF THE INVENTION [0001] The present invention relates to a method of treating insulin resistance, adult onset diabetes, and metabolic syndrome X and its related complications in a mammal using a therapeutic liposomal suspension, comprising predominantly phospholipids. BACKGROUND OF THE INVENTION [0002] For maintenance of homeostasis, it is critical to keep a constant supply of glucose to the cells to avoid the occurrence of dysglycemia and its related metabolic imbalances. If left ignored or untreated, metabolic dysglycemia would lead to numerous metabolic diseases, including obesity, heart disease, hypertension, diabetes, chronic fatigue, accelerated aging, degenerative disease, as well as many mental and emotional problems. For this reason, it is important to identify and, at the same time, treat this condition early before costly and disabling degenerative conditions arise that can ruin the quality of life as well as shorten it. [0003] Dysglycemia and diabetes show up very ...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61KA61K9/00A61K9/127A61K38/17A61M
CPCA61K9/127A61K9/0019A61P3/00A61P3/10
Inventor KURTZ, SEYMOUR J
Owner KURTZ SEYMOUR J
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