Pancreatic Volume in Preclinical Type 1 Diabetes
The purpose of the study is to determine differences in pancreatic volume between new-onset Type 1 Diabetes (T1D) patients, antibody positive subjects at increased risk for T1D, and healthy controls. It will also be used to determine if pancreatic volume correlates with indirect biochemical markers of endocrine and exocrine pancreatic function.
Type 1 diabetes is characterized by a progressive destruction of insulin producing beta cells, resulting in lifelong dependence on exogenous insulin. While beta cells make up less than 1% of the pancreas, studies have demonstrated that T1D is associated with a marked reduction of pancreatic mass at diagnosis and as the disease progresses. As such, if pancreatic volume assessment, by ultrasonography (US) or MRI (Magnetic Resonance Imaging), could be utilized as a marker of beta cell function in high risk patients, non-invasive pancreatic imaging could become an important part of staging diabetes risk.
This study will help researchers determine whether people who are at high risk of type 1 diabetes start out with smaller pancreas volume or whether the beginning of the onset of the disease causes the pancreas volume to shrink.
By using traditional, non-invasive tools such as MRI and ultrasound, UF Health researchers will measure and estimate the pancreas volumes of four sets of individuals between the ages of 10 and 45 years of age:
• People who have recently been diagnosed with Type 1 diabetes
• People at little risk of developing the disease who are matched with the other groups based on age, gender, and BMI.
• People at risk of developing Type 1 diabetes due to the presence of serum autoantibodies (those with single and multiple autoantibodies)
Researchers plan to recruit 100 patients per year for three years, from Florida and the southeast region. For more information on this study being conducted at UF Health, please contact Miriam Cintron at (352) 273-5580 or email@example.com.
Novartis Secukinumab Study
The purpose of this research study is to test whether a new compound called secukinumab is safe in adult and pediatric subjects with T1D and whether it can preserve the remaining beta cells. It is recommended that this compound be given as soon as a subject is diagnosed with T1D, no longer than 100 days from diagnosis in an attempt to preserve the remaining beta cells. Studies have shown that subjects who maintain some beta cells have a better control of their blood sugar in the long run and a lower risk of eye and kidney complications.
This is the first time secukinumab is being studied in people with type 1 diabetes mellitus. It is currently being tested in other diseases such as: rheumatoid arthritis, multiple sclerosis, psoriasis, ankylosing spondylitis, uveitis, and asthma. So far, more than 6,000 subjects have received secukinumab in clinical trials worldwide.
Initially this multicenter study will enroll persons recently diagnosed with T1D who are 18 through 35 years old. For more information on this study being conducted at UF Health, please contact Miriam Cintron at (352) 273-5580 or firstname.lastname@example.org.