US2017156387A1PendingUtilityA1

Continuous monitoring of blood glucose production and ongoing targeting of blood glucose production via nutritional support

Individually held — no corporate assignee on recordPriority: Oct 25, 2012Filed: Dec 31, 2016Published: Jun 8, 2017

Est. expiryOct 25, 2032(~6.2 yrs left)· nominal 20-yr term from priority

Inventors:George A. Brooks Michael A. Horning

A61P 3/08A61K 31/155A23L 33/30A61K 31/225A61K 31/7004A61K 31/22G01N 33/66A61K 31/047A23V 2002/00A61K 47/02Y10T436/144444A61K 31/198A61K 31/19A23L 33/10A61K 31/221G01N 33/58A61K 9/0029

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References

Claims

Abstract

Systems, techniques and methods for estimating the metabolic state or flux, e.g., the body energy state (“BES”) of a patient, are disclosed. The BES provides deep insight into the nutritional needs of the patient, thus allowing for a sort of exquisite glycemic control with regard to the patient. The invention discloses systems and methods for estimating fractional gluconeogenesis, which is the % of glucose production that comes from gluconeogenesis (“GNG”), as opposed to glycogenolysis (“GLY”), the other form of glucose production. Nutritional formulations, materials, cocktails and methods for feeding patients by parenteral and other means are disclosed. The amount, type and rate of such nutritional feeding are typically based upon the above estimating. The invention discloses formulations that contain labels, such as deuterium, for medical diagnostics, such as for estimating BES and fractional gluconeogenesis. The invention is suitable for any sort of patient, including those who are injured, such as with traumatic brain injury, ill, or have other conditions that stress the metabolic system.

Claims

exact text as granted — not AI-modified

What is claimed is:

1 . A method of ongoing monitoring of nutritional status and ongoing administering of a nutritional support to a human patient, the method comprising:
obtaining a value or set of values for a fractional gluconeogenesis from a single mass spectrometric reading on a blood sample from the patient; based on the obtained value or set of values, if the fractional gluconeogenesis is above about 15-30%, administering the nutritional support to the patient; and repeating the obtaining and the administering at least once;

2 . The method of claim 1 wherein the patient is injured or ill.

3 . The method of claim 1 wherein the administering a nutritional support includes:
beginning to administer the support if the support was not previously given; or
continuing to administer the support in a same rate or amount or a different rate or amount, if the support was previously given.

4 . The method of claim 1 wherein the nutritional support comprises a gluconeogenic precursor or monocarboxylic compound or both.

5 . The method of claim 1 wherein the nutritional support is administered if the fractional gluconeogenesis is above about 20-25%.

6 . The method of claim 1 wherein the nutritional support comprises one or more salts.

7 . The method of claim 1 wherein the nutritional support comprises one or more of the following: Na + , K + , Ca ++ , Mg ++ , HPO 4 −2 and H 2 PO 4 − .

8 . The method of claim 1 wherein the nutritional support comprises a molecular label.

9 . The method of claim 1 wherein the nutritional support comprises a deuterium label.

10 . The method of claim 1 wherein the nutritional has a milliosmolality of less than about 1000.

11 . The method of claim 1 wherein the nutritional support comprises a gluconeogenic precursor or monocarboxylic compound other than lactate.

12 . The method of claim 1 wherein the nutritional support comprises an amino acid.

13 . The method of claim 1 wherein the nutritional support comprises one or more the following:
glycerol, glycerol tri-lactate or arginyl lactate.

14 . The method of claim 1 wherein the nutritional support is administered at a rate of about 3 mg/kg/min, where kg is kg of patient body weight and 3 mg is the amount of gluconeogenic precursor or monocarboxylic compound in the formulation.

15 . The method of claim 1 wherein the nutritional support is administered at a rate of about 50 micromoles/kg/min, where kg is kg of patient body weight and 50 micromoles is the amount of gluconeogenic precursor or monocarboxylic compound in the formulation.

16 . The method of claim 1 wherein the nutritional support is one or more of the following: oral, parenteral, or enteral.

17 . The method of claim 1 wherein the value or set of values in is obtained from analysis of a single glucose derivative.

18 . The method of claim 1 wherein the value or set of is obtained from a penta-acetate glucose derivative.

19 . The method of claim 1 wherein the method further obtains a value or set of values for glucose rate of appearance.

20 . The method of claim 1 wherein the method further obtains a blood lactate concentration.

21 . A method of ongoing monitoring of nutritional status and ongoing administering of a nutritional support to a human patient, the method comprising:
receiving a value or set of values for a fractional gluconeogenesis from a single mass spectrometric reading on a blood sample from the patient; based on the received value or set of values, if the fractional gluconeogenesis is above about 15-30%, administering the nutritional support to the patient; and repeating the obtaining and the administering at least once;

22 . The method of claim 21 wherein the patient is injured or ill.

23 . The method of claim 21 wherein the administering a nutritional support includes:
beginning to administer the support if the support was not previously given; or
continuing to administer the support in a same rate or amount or a different rate or amount, if the support was previously given.

24 . The method of claim 21 wherein the nutritional support comprises a gluconeogenic precursor or monocarboxylic compound or both.

25 . The method of claim 21 wherein the nutritional support is administered if the fractional gluconeogenesis is above about 20-25%.

26 . The method of claim 21 wherein the nutritional support comprises one or more salts.

27 . The method of claim 21 wherein the nutritional support comprises one or more of the following: Na + , K + , Ca ++ , Mg ++ , HPO 4 −2 and H 2 PO 4 − .

28 . The method of claim 21 wherein the nutritional support comprises a molecular label.

29 . The method of claim 21 wherein the nutritional support comprises a deuterium label.

30 . The method of claim 21 wherein the nutritional has a milliosmolality of less than about 1000.

31 . The method of claim 21 wherein the nutritional support comprises a gluconeogenic precursor or monocarboxylic compound other than lactate.

32 . The method of claim 21 wherein the nutritional support comprises an amino acid.

33 . The method of claim 21 wherein the nutritional support comprises one or more the following:
glycerol, glycerol tri-lactate or arginyl lactate.

34 . The method of claim 21 wherein the nutritional support is administered at a rate of about 3 mg/kg/min, where kg is kg of patient body weight and 3 mg is the amount of gluconeogenic precursor or monocarboxylic compound in the formulation.

35 . The method of claim 21 wherein the nutritional support is administered at a rate of about 50 micromoles/kg/min, where kg is kg of patient body weight and 50 micromoles is the amount of gluconeogenic precursor or monocarboxylic compound in the formulation.

36 . The method of claim 21 wherein the nutritional support is one or more of the following: oral, parenteral, or enteral.

37 . The method of claim 21 wherein the value or set of values in is obtained from analysis of a single glucose derivative.

38 . The method of claim 21 wherein the value or set of is obtained from a penta-acetate glucose derivative.

39 . The method of claim 21 wherein the method further obtains a value or set of values for glucose rate of appearance.

40 . The method of claim 21 wherein the method further obtains a blood lactate concentration.

41 . A method of targeting a fractional gluconeogenesis range in a patient, the method comprising:
obtaining a value or set of values for a fractional gluconeogenesis from a single mass spectrometric reading on a blood sample from the patient; based on the obtained value or set of values, targeting a fractional gluconeogenesis range of about 15-30% by administering a nutritional support to the patient.

42 . The method of claim 41 wherein the patient is injured or ill.

43 . The method of claim 41 wherein the administering a nutritional support includes:
beginning to administer the support if the support was not previously given; or
continuing to administer the support in a same rate or amount or a different rate or amount, if the support was previously given.

44 . The method of claim 41 wherein the nutritional support comprises a gluconeogenic precursor or monocarboxylic compound or both.

45 . The method of claim 41 wherein the nutritional support is administered if the fractional gluconeogenesis is above about 20-25%.

46 . The method of claim 41 wherein the nutritional support comprises one or more salts.

47 . The method of claim 41 wherein the nutritional support comprises one or more of the following: Na + , K + , Ca ++ , Mg ++ , HPO 4 −2 and H 2 PO 4 − .

48 . The method of claim 41 wherein the nutritional support comprises a molecular label.

49 . The method of claim 41 wherein the nutritional support comprises a deuterium label.

50 . The method of claim 41 wherein the nutritional has a milliosmolality of less than about 1000.

51 . The method of claim 41 wherein the nutritional support comprises a gluconeogenic precursor or monocarboxylic compound other than lactate.

52 . The method of claim 41 wherein the nutritional support comprises an amino acid.

53 . The method of claim 41 wherein the nutritional support comprises one or more the following:
glycerol, glycerol tri-lactate or arginyl lactate.

54 . The method of claim 41 wherein the nutritional support is administered at a rate of about 3 mg/kg/min, where kg is kg of patient body weight and 3 mg is the amount of gluconeogenic precursor or monocarboxylic compound in the formulation.

55 . The method of claim 41 wherein the nutritional support is administered at a rate of about 50 micromoles/kg/min, where kg is kg of patient body weight and 50 micromoles is the amount of gluconeogenic precursor or monocarboxylic compound in the formulation.

56 . The method of claim 41 wherein the nutritional support is one or more of the following: oral, parenteral, or enteral.

57 . The method of claim 41 wherein the value or set of values in is obtained from analysis of a single glucose derivative.

58 . The method of claim 41 wherein the value or set of is obtained from a penta-acetate glucose derivative.

59 . The method of claim 41 wherein the method further obtains a value or set of values for glucose rate of appearance.

60 . The method of claim 41 wherein the method further obtains a blood lactate concentration.

61 . A method of targeting a fractional gluconeogenesis range in a patient, the method comprising:
receiving a value or set of values for a fractional gluconeogenesis from a single mass spectrometric reading on a blood sample from the patient; based on the received value or set of values, targeting a fractional gluconeogenesis range of about 15-30% by administering a nutritional support to the patient.

62 . The method of claim 61 wherein the patient is injured or ill.

63 . The method of claim 61 wherein the administering a nutritional support includes:
beginning to administer the support if the support was not previously given; or
continuing to administer the support in a same rate or amount or a different rate or amount, if the support was previously given.

64 . The method of claim 61 wherein the nutritional support comprises a gluconeogenic precursor or monocarboxylic compound or both.

65 . The method of claim 61 wherein the nutritional support is administered if the fractional gluconeogenesis is above about 20-25%.

66 . The method of claim 61 wherein the nutritional support comprises one or more salts.

67 . The method of claim 61 wherein the nutritional support comprises one or more of the following: Na + , K + , Ca ++ , Mg ++ , HPO 4 −2 and H 2 PO 4 − .

68 . The method of claim 61 wherein the nutritional support comprises a molecular label.

69 . The method of claim 61 wherein the nutritional support comprises a deuterium label.

70 . The method of claim 61 wherein the nutritional has a milliosmolality of less than about 1000.

71 . The method of claim 61 wherein the nutritional support comprises a gluconeogenic precursor or monocarboxylic compound other than lactate.

72 . The method of claim 61 wherein the nutritional support comprises an amino acid.

73 . The method of claim 61 wherein the nutritional support comprises one or more the following:
glycerol, glycerol tri-lactate or arginyl lactate.

74 . The method of claim 61 wherein the nutritional support is administered at a rate of about 3 mg/kg/min, where kg is kg of patient body weight and 3 mg is the amount of gluconeogenic precursor or monocarboxylic compound in the formulation.

75 . The method of claim 61 wherein the nutritional support is administered at a rate of about 50 micromoles/kg/min, where kg is kg of patient body weight and 50 micromoles is the amount of gluconeogenic precursor or monocarboxylic compound in the formulation.

76 . The method of claim 61 wherein the nutritional support is one or more of the following: oral, parenteral, or enteral.

77 . The method of claim 61 wherein the value or set of values in is obtained from analysis of a single glucose derivative.

78 . The method of claim 61 wherein the value or set of is obtained from a penta-acetate glucose derivative.

79 . The method of claim 61 wherein the method further obtains a value or set of values for glucose rate of appearance.

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