Monitoring method of renal lesions without clinical signs

Details Monitoring method of renal lesions without clinical signs Monitoring method of renal lesions without clinical signs

1995-09-19

1997-09-02

Mendez, Manuel

Surgery

Means for introducing or removing material from body for...

Material introduced into and removed from body through...

A61K 3800

Patent

active

056626045

DESCRIPTION:

BRIEF SUMMARY
FIELD OF THE INVENTION

This invention relates to a novel screening method for renal lesions in diabetic patients not yet exhibiting symptoms of nephropathy, comprising administering a predetermined amount of parathyroid hormone, analogue thereof or derivative thereof (hereinafter sometimes simply designated as PTH) to patients with diabetes mellitus having an albumin excretion rate (AER) of less than 15 .mu.g/min, measuring urinary excreted N-acetyl-.beta.-D-glucosaminidase (NAG) and urinary creatinine in urinary samples taken 60.+-.10 minutes prior to and after administration of PTH, and monitoring the ratio of urinary excreted NAG (U/g Cr) after administration of PTH to the urinary excreted NAG (U/g Cr) prior to administration of PTH for a value of less than 2.3.
More particularly, the present invention relates to method for early detection of diabetic nephropathy using a preparation essentially consisting of active ingredient of PTH.


BACKGROUND OF THE INVENTION

Disease of diabetes mellitus is primarily due to an insufficiency of insulin action. Clinical diagnosis of diabetes is defined generally by typical symptoms of diabetes mellitus showing thirsty, polyuria and weight loss, with hyperglycemia and overflow glycosuria, indicating a plasma glucose level of over 200 mg/dl, or if the above symptoms are found by a blood sugar determination with generally a glucose tolerance test. Diabetes mellitus is often accompanied with various complication and a prognosis of diabetes mellitus is influenced by the complications. Angiopathy, a major complication of diabetes mellitus, is mainly classified in the micro angiopathy including diabetic retinopathy and diabetic nephropathy, and the macroangiopathy including ischemic heart disease and cerebrovascular disorder.
Diabetic nephropathy is an important chronic complication for the prognosis of diabetes mellitus. Accordingly, an early detection of diabetic nephropathyand an early prevention of its progress would be extremely desirable. Symptoms of diabetic nephropathy are defined, as illustrated in the reference [Diabetic Nephropathy, Ed. Friedman, E. A., p.75 (1986), FIGS. 5-8], by observing the level of urinary protein in the patients, as a term of temporary increase in exercise-induced microalbumin excretion followed by detecting persistent proteinuria with a yearly increase in protein and a gradual decrease in creatinine clearance as a result of progressing nephropathy.
Heretofore diabetic nephropathy in patients having diabetes mellitus has been diagnosed by appearance of clinically detectable proteinurea. In this clinical stage, histopathological changes markedly progressed with decreased renal function and the lesions appeared to be irreversible [Diabetes, Vol. 32, Suppl. 2, p.64 (183) and Diabetic Nephropathy, Ed, Friedman, E. A., p.65 (1986)].
Recently, trace urinaryalbumin could be detected by radioimmunoassay, and nephropathycan be diagnosed at an early stage prior to detecting persistent proteinurea [Diabetes, Vol. 32, Suppl. 2, p. 64 (1983)]. In the event that urinary trace albumin is detected, then further continued progress of 6-14 years persistent proteinuria can be observed. Urinary trace albumin is generally expressed by AER from timed excretion of urine, and has a threshold value of 15-30 .mu.g/min. The overflow value is defined as microalbuminuria and is diagnosed as diabetic nephropathy [Acta Endocrinol., 100:550 (1982), New Eng. J. Med., 331:89 (1983) and Lancet, 26:1430 (1982)].
Conventionally used parameters for reflecting renal function are urinary .beta.2-microglubulin and urinary NAG [J. Clin. Invest., 48:1189 (1969) and Toxicology, 23:99 (1982)]. However, these parameters are not sensitive markers for early diagnosis of diabetic nephropathy.
In patients of early diabetic nephropathy with detected microalbuminuria, there is a known mechanism for affecting a glomerular filtration barrier. Transglomerular passage of plasma proteins depends on the following factors, including 1) structural changes of glomerular membrane, 2) changes in renal

REFERENCES:
patent: 4469681 (1984-09-01), Brownlee et al.
patent: 5494905 (1996-02-01), Hesse et al.
T. Kawagishi et al., "Calcium Metabolism in Diabetes Mellitus", J. Nutr. Sci. Vitaminol, vol. 37, (Suppl.), 1991, pp. S51-S56.
Y. Furukawa, "Special/Calcium Metabolism Abnormality Pseudohypoparathyroidism", Hormone and Clinical, vol. 40, No. 6, 1992, pp. 585-592.
E. Morita et al., "Clinical Significance of Urinary Enzymes in Diabetes Mellitus", J. UOEH. Occup. Environ. Heal, vol. 12, No. 2, 1990, pp. 197-205.

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