This study will evaluate the efficacy and safety of 2 dose levels of NTRA-2112 on intestinal malabsorption in preterm infants as compared to placebo. NTRA-2112 is a powder of insulin formulation for reconstitution in breast milk, infant formula, normal and half-normal saline administered with the preterm infant's formula, donor breast milk, or own mother's breast milk for local gastrointestinal (GI) therapy. The effect on intestinal malabsorption will be evaluated by comparing the ability of preterm infants to achieve full enteral (EN) feeding for 3 consecutive days.
The study will enroll preterm infants weighing at least 500g born between 26 and 32 weeks of pregnancy who meet inclusion and exclusion criteria. Infants will be treated for 28 days or until discharged from the hospital, whichever happens first. Patients will be randomly-assigned to one of three treatment arms: Treatment A 400 ?U/ml ? equivalent dose of insulin or NTRA-2112; Treatment B to
obtain 2000 ?U/ml dose of insulin; or placebo as calculated according to planned daily enteral intake. During the treatment period, infants will undergo daily evaluation of nutrition, general growth, gastric residuals, development progression, and any side effects.
Patients will be evaluated at day of discharge along with follow-up clinic visits performed at 3 months, 12 months, and 24 months corrected age.
The purpose of this research study is to learn more about the outcomes of total pancreatectomy with islet autotransplantation (TPIAT). Total pancreatectomy is the removal of the pancreas and islet autotransplantation is the placement of the insulin producing cells back into you to prevent diabetes. This study is looking to enroll patients who are scheduled to have a TPIAT surgery to treat pancreatitis (inflammation and scarring of the pancreas).
In addition to the routine care for pancreatitis and TPIAT surgery, participation in this study will involve completion of some brief surveys about the subject's health before TPIAT, at 6 months after TPIAT, and each year after the TPIAT surgery for 4 years, as well as a lab test conducted at each of the follow-up visits.
The purpose of this study is to test whether treatment with a drug called alpha 1 antitrypsin (AAT, Prolastin, Grilfols, Inc.) can reduce the chance of getting diabetes in a specific situation. Sometimes patients have their pancreas gland removed for pain. Since the pancreas makes insulin from cells called islet cells, these are removed from the pancreas and returned to the body to try decrease the chance of diabetes. The only participants invited to this study are those individuals getting ready to have the pancreas surgery.
This study is providing annual blood tests looking at diabetes autoantibodies for first degree relatives of patients diagnosed with type 1 diabetes who are between the ages of 1 and 45. It will also provide "diabetes screening" for second and third degree relatives age 1-20. Often parents and/or relatives wonder "if they will get diabetes" down the road or if additional offspring are "at risk" for type 1 diabetes. This study aims at assisting families with free blood testing. If positive, participants will be eligible for "prevention studies". MUSC is currently only participating in the "screening" portion of TrialNet.