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Research Article
Volume 6 Issue 4 - 2021
Pulsatile Insulin Infusion as a Treatment Option for Patients with Type 2 Diabetes and Stage III Kidney Failure - Results from a Pilot Study
Manessis A1,2, Hanna MR3,4, Sachsenheimer D3, Do L2, Lewin JC4, Steiner SS4, McCormack S4, Demircik F5 and Pfützner A3,4,6*
1NYU Grossman School of Medicine, NY, USA
2Endocrine Associates of Western Village, NY, USA
3Pfützner Science and Health Institute, Mainz, Germany
4Diakard Inc., Franklin, TN, USA
5Sciema GmbH, Mainz, Germany
6Institute for Internal Medicine and Laboratory Medicine, University for Digital Technologies in Medicine and Dentistry, Wiltz, Luxemb
*Corresponding Author: Pfützner A, Pfützner Science and Health Institute, Mainz, Germany.
Received: March 31, 2021; Published: March 31, 2021


Introduction: Mimicking the physiological pancreatic pulsatile insulin secretion has led to the concept of pulsatile insulin infusion therapy (PIT).

Methods: This pilot study investigated the effect of once weekly PIT for 3 months on kidney function in patients with type 2 diabetes and chronic renal failure (glomerular filtration rate (GFR) < 60 mL/min or GFR < 75 mL/min with macroproteinurea).

Results: Of 22 enrolled type 2 patients, 17 completed the trial per protocol (7 women, 10 men, age: 69 ± 7 yrs., HbA1c: 7.9 ± 1.0%). After 3 months, mean GFR improved by 12% (from 47.6 ± 10.0 mL/min to 53.3 ± 11.9 mL/min, p < 0.01) and mean serum creatinine decreased by 7% (1.4 ± 0.3 mg/dL/1.3 ± 0.3 mg/dL, p < 0.05). Systolic blood pressure improved by 6% (p < 0.05), while HbA1c and body weight remained stable. The treatment satisfaction score improved from 3.7 ± 2.7 to 2.7 ± 2.1 (p < 0.005). The PIT procedures were well tolerated and only few cases of muscle cramps were considered to be related to the treatments.

Conclusion: Improvements in kidney function, systolic blood pressure and treatment satisfaction were observed after 3 months of PIT in patients with type 2 diabetes and renal failure in this pilot trial. These results will now be used to plan for appropriately designed controlled confirmatory studies.

Keywords: Pulsatile Insulin Infusion Therapy (PIT); Type 2 Diabetes; Stage III Kidney Failure


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Citation: Pfützner A., et al. “Pulsatile Insulin Infusion as a Treatment Option for Patients with Type 2 Diabetes and Stage III Kidney Failure - Results from a Pilot Study”. EC Gastroenterology and Digestive System 6.4 (2021): 49-54.

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