• Diabetes Mellitus
• Diabetes & Endocrinology Clinical Trials

• Endocrinology
• Diabetes & Metabolic Syndrome
• Diabetes Mellitus
• Diabetes & Endocrinology Clinical Trials

Researchers have demonstrated in a decadelong study that pancreas transplantation alone (PTA) can be effective and safe for patients with type 1 diabetes mellitus (T1DM), with the caveat that this advance benefits select, not all, patients with T1DM. The findings were reported by Margherita Occhipinti, MD, University of Pisa, Pisa, Italy.

PTA was first reported in the late 1960s. Advances in areas including immunosuppressive therapy have considerably improved patient outcomes [Gruessner RWG, Gruessner AC. Diabetes Care 2013]. Still, the long-term outlook is unclear. In the Pisa group, experience with pancreas and kidney transplantation dates back to the development of PTA, with 355 PTA procedures having been performed in 337 patients. This study sought to determine the actual 10-year PTA results in this single center.

The study involved 34 patients (17 men, 17 women) who underwent PTA from December 2000 to December 2003. The patients were aged 37 ± 9 years, had a body mass index of 23.5 ± 3.3 kg/m² and a duration of diabetes of 23 ± 10 years, and received 47 ± 10 U of insulin daily. All patients were transplanted by use of the portal-enteric drainage approach. Immunosuppressive therapy consisted of basiliximab (20 mg on Days 0 and 4) and high-dose steroids. Maintenance therapy consisted of tacrolimus, mycophenolate, and low-dose steroids.

The 10-year data revealed patient and pancreas survival rates of 97.0% and 63.6%, respectively, representing 1 death due to stroke (graft functional at time of death) and 12 cases of graft failure due to acute rejection in 2 patients and chronic rejection in 10 patients.

Blood levels of tacrolimus at 6 months and 10 years were 11.53 ng/mL and 8.72 ng/mL, respectively. Mycophenolate mofetil was used exclusively through 6 months (2000 mg/day), but by 10 years sodium mycophenolate 750 mg/day was used in 60% and mycophenolate mofetil 1250 mg/day in 40% of patients. Steroid use declined from 97% of patients at 6 months to 88% of patients at 5 years to 42% of patients at 10 years. C-peptide increased markedly from commencement of treatment in the first year and remained the same thereafter. Fasting plasma glucose and HbA1C declined at about 1 year and then remained constant. Comparisons of patients prior to surgery and at 10 years revealed significant decreases in total cholesterol and low-density lipoprotein cholesterol (LDL-C; p< .001 for both), with insignificant declines in high-density lipoprotein cholesterol and triglyceride.

Blood pressure (BP) measurements demonstrated significant declines from baseline in systolic BP at 1 and 5 years, and in diastolic BP only at 1 year. The left ventricular ejection fraction (LVEF) significantly increased from 54% at baseline to 59% at 10 years (p< .001). Kidney function declined by a mean 1.8 ± 2 mL/min annually; the overall decrease was not significant.

In this 10-year study, pancreas transplant alone was associated with satisfactory long-term patient and graft control, long-term restoration of endogenous insulin secretion and normalization of glycemic control, significant improvement in levels of total cholesterol and low-density lipoprotein, improved left ventricular ejection fraction, and a level of kidney function judged to be reasonable. Thus, the approach was concluded to be safe and effective for selected patients with T1DM.

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