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eGFR improved by 10.8% and creatinine decreased by 6.8% in patients who received PIT procedures.
Pulsatile insulin treatment (PIT) results in marked improvements kidney function in type 2 diabetes patients suffering from renal failure.
In a late-breaking poster presented during the 2021 American Diabetes Association Virtual Meeting, a team, led by Sophia Quach, clinical assistant at the Endocrine Associates of West Village, investigated the effect of once weekly PIT for 2 or 3 hour procedures over a 3 month period on the parameters of kidney function in patients with type 2 diabetes and chronic renal failure.
“In healthy individuals, insulin is secreted by the pancreatic ß-cells in a pulsatile fashion with about 10-12 pulses/hour,” the authors wrote. “Loss of this pulsatility is one of the first indications of ß-cell dysfunction leading to type 2 diabetes. This pulsatility of insulin secretion is considered a trigger mechanism for the regulation of hepatic gluconeogenesis and for maintaining the sensitivity of peripheral metabolic and vascular insulin receptors.”
There have been several attempts over the last 3 decades to pulsatile i.v. insulin infusion therapy to treat diabetes, as well as secondary complications.
In the prospective randomized pilot study, the researchers examined 17 patients with type 2 diabetes who received a total of 10 PIT procedures. The investigators measured observation parameters at baseline, with endpoints of HbA1c, GFR, body weight, blood pressure, creatinine, nerve perception thresholds, and treatment satisfaction.
At the conclusion of the study there was not significant differences found between the 2 groups, while GFR improved by 10.8% and creatinine decreased by 6.8%.
The investigators also found stable results for HbA1c, body weight, and blood pressure, with no changes seen in nerve perception thresholds of any of the investigated sensory fiber qualities.
The treatments were also well-tolerated, but there were 8 treatment events of muscle cramps reported by 5 patients during the PIT procedures.
“In conclusion, an improvement in kidney function and treatment satisfaction was observed after 3 months of PIT in patients with type 2 diabetes and renal failure, irrespective of the duration of the procedure,” the authors wrote. “The results of this pilot trial will now be used to design an appropriate confirmatory study to investigate the effect of PIT when given in addition to standard of care treatment vs. standard of care alone.”
Recently, Bayer released new cardiovascular outcomes from a phase 3 trial testing finerenone as an addition to standard of care treatment in patients with chronic kidney disease and type 2 diabetes.
The company announced researchers have met the primary endpoint in the FIGARO-DKD study showing finerenone significantly reduced the composite risk of time to first occurrence of cardiovascular death or non-fatal cardiovascular events including myocardial infarction, stroke, or hospitalization for heart failure.
Finerenone is an investigational, non-steroidal, selective mineralocorticoid receptor antagonist (MRA). The treatment has shown promise in reducing the harmful effects of mineralocorticoid receptor (MR) overactivation, a known driver of kidney and cardiovascular damage through inflammatory and fibrotic processes.
The study, “Pulsatile Insulin Treatment as a Treatment Option for Patients with Type 2 Diabetes and Stage 3 Kidney Failure,” was published online by ADA.