Diabetic nephropathy: Study results on proteomic analysis do not show benefit

July 06, 2020

One of the consequences of diabetes mellitus, particularly if accompanied by high blood pressure (hypertension), can be a chronic kidney disease (diabetic nephropathy), which can lead to permanent failure of the kidneys (end-stage renal disease). The German Institute for Quality and Efficiency in Health Care (IQWiG) now produced a rapid report to investigate the advantages or disadvantages of a diagnostic-therapeutic strategy using a proteomic analysis of the urine in comparison with a conventional diagnostic-therapeutic strategy to prevent renal disorders by early diagnosis and therapy.

This investigation was prompted by the results of the first randomized trial on an early therapy of patients who, according to the proteomic analysis, had a high risk of a kidney disease. These patients received either treatment with spironolactone or placebo. However, the study results did not suggest any advantages or disadvantages of an early proteomic analysis in combination with the administration of spironolactone for any of the patient-relevant outcomes.

This conclusion is the update of an earlier benefit assessment of proteomic analysis conducted by IQWiG in 2015 (D13-01).

Proteomic analysis aims to detect impending diabetic nephropathy earlier

When clear symptoms occur, diabetic nephropathy (DN) is already far progressed. Proteomic analysis determines the concentration of several biomarkers in the urine by means of mass spectrometry. The values calculated in this analysis are supposed to allow earlier and more precise clinical conclusions on the development of DN than conventional diagnostic methods.

However, the PRIORITY study provided no hint of a benefit or harm of spironolactone administration based on a proteomic analysis regarding the following patient-relevant outcomes: all-cause mortality, chronic kidney disease, cardiovascular morbidity (ischaemic heart disease, stroke, cardiac failure, etc.), damage to the retina of the eyes in need of treatment (retinopathy), and serious adverse events. There were no data on health-related quality of life.

With the results of the PRIORITY study, it is therefore still unknown which therapeutic consequence from the test result of the proteomic analysis could offer a benefit for patients. Further ongoing or planned studies on proteomic analysis in people with diabetes and hypertension were not identified.

Process of report production

IQWiG had sent the first benefit assessment on proteomic analysis as final report D13-01 in September 2015 to the commissioning agency, the Federal Joint Committee (G-BA). The G-BA then suspended its decision on proteomic analysis in patients with diabetes mellitus and arterial hypertension with the provision that the hitherto unanswered questions had to be answered on the basis of informative scientific documents.

The G-BA resumed the assessment procedure in 2019, and commissioned IQWiG in December 2019 with the assessment of the benefit of proteomic analysis in patients with diabetes mellitus and arterial hypertension, particularly under consideration of the results of the PRIORITY study, which had been completed in the meantime. IQWiG was to prepare the report in an accelerated process, known as a "rapid report". Interim products were therefore not published and were not the subject of a hearing.
-end-


Institute for Quality and Efficiency in Health Care

Related Diabetes Articles from Brightsurf:

New diabetes medication reduced heart event risk in those with diabetes and kidney disease
Sotagliflozin - a type of medication known as an SGLT2 inhibitor primarily prescribed for Type 2 diabetes - reduces the risk of adverse cardiovascular events for patients with diabetes and kidney disease.

Diabetes drug boosts survival in patients with type 2 diabetes and COVID-19 pneumonia
Sitagliptin, a drug to lower blood sugar in type 2 diabetes, also improves survival in diabetic patients hospitalized with COVID-19, suggests a multicenter observational study in Italy.

Making sense of diabetes
Throughout her 38-year nursing career, Laurel Despins has progressed from a bedside nurse to a clinical nurse specialist and has worked in medical, surgical and cardiac intensive care units.

Helping teens with type 1 diabetes improve diabetes control with MyDiaText
Adolescence is a difficult period of development, made more complex for those with Type 1 diabetes mellitus (T1DM).

Diabetes-in-a-dish model uncovers new insights into the cause of type 2 diabetes
Researchers have developed a novel 'disease-in-a-dish' model to study the basic molecular factors that lead to the development of type 2 diabetes, uncovering the potential existence of major signaling defects both inside and outside of the classical insulin signaling cascade, and providing new perspectives on the mechanisms behind insulin resistance in type 2 diabetes and possibly opportunities for the development of novel therapeutics for the disease.

Tele-diabetes to manage new-onset diabetes during COVID-19 pandemic
Two new case studies highlight the use of tele-diabetes to manage new-onset type 1 diabetes in an adult and an infant during the COVID-19 pandemic.

Genetic profile may predict type 2 diabetes risk among women with gestational diabetes
Women who go on to develop type 2 diabetes after having gestational, or pregnancy-related, diabetes are more likely to have particular genetic profiles, suggests an analysis by researchers at the National Institutes of Health and other institutions.

Maternal gestational diabetes linked to diabetes in children
Children and youth of mothers who had gestational diabetes during pregnancy are at increased risk of diabetes themselves, according to new research published in CMAJ (Canadian Medical Association Journal).

Two diabetes medications don't slow progression of type 2 diabetes in youth
In youth with impaired glucose tolerance or recent-onset type 2 diabetes, neither initial treatment with long-acting insulin followed by the drug metformin, nor metformin alone preserved the body's ability to make insulin, according to results published online June 25 in Diabetes Care.

People with diabetes visit the dentist less frequently despite link between diabetes, oral health
Adults with diabetes are less likely to visit the dentist than people with prediabetes or without diabetes, finds a new study led by researchers at NYU Rory Meyers College of Nursing and East Carolina University's Brody School of Medicine.

Read More: Diabetes News and Diabetes Current Events
Brightsurf.com is a participant in the Amazon Services LLC Associates Program, an affiliate advertising program designed to provide a means for sites to earn advertising fees by advertising and linking to Amazon.com.