Study: NCT05659147

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: Research MRI without administration of intravenous secretin
Description: Participants will undergo a research MRI examination. MRI images will be quantitatively analyzed and will be compared to / used to predict diabetes.

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: Research MRI with administration of intravenous secretin
Description: Participants will undergo a research MRI examination with intravenous administration of secretin. MRI images will be quantitatively analyzed and will be compared to / used to predict exocrine and endocrine pancreatic insufficiency based on the reference standards of ePFTs or fecal elastase and blood hemoglobin A1c (HbA1c) and fasting glucose, respectively.

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: Research MRI with administration of intravenous secretin
Description: Participants will undergo a research MRI examination with intravenous administration of secretin. MRI images will be quantitatively analyzed and will be compared to / used to predict exocrine and endocrine pancreatic insufficiency based on the reference standards of ePFTs or fecal elastase and blood hemoglobin A1c (HbA1c) and fasting glucose, respectively.

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: Research MRI with administration of intravenous secretin
Description: Participants will undergo a research MRI examination with intravenous administration of secretin. MRI images will be quantitatively analyzed and will be compared to / used to predict exocrine and endocrine pancreatic insufficiency based on the reference standards of ePFTs or fecal elastase and blood hemoglobin A1c (HbA1c) and fasting glucose, respectively.

Intervention type: GENETIC
Group type: EXPERIMENTAL
Intervention: Genetic Sequencing
Description: Blood will be drawn to enable gene sequencing for gene mutations associated with heritable pancreatitis. We will assess the association between identified gene variants and the presence of diabetes and will construct models based on identified variants to predict progression to diabetes.

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: Blood Tests
Description: Research blood draw (for markers of pancreatic endocrine insufficiency)

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: Blood Tests
Description: Research blood draw (for markers of pancreatic endocrine insufficiency)

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: Blood Tests
Description: Research blood draw (for markers of pancreatic endocrine insufficiency)

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: Stool Tests
Description: Research stool collection (for fecal elastase as a marker of exocrine insufficiency)

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: Stool Tests
Description: Research stool collection (for fecal elastase as a marker of exocrine insufficiency)

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Survey Completion
Description: Participants will be contacted to complete a survey and their charts will be reviewed annually after research MRI to identify any evidence of subsequent development of pancreatic endocrine insufficiency or progression of pancreatitis. Survey and chart review will occur within +/- 14 days of the anniversary date.

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Survey Completion
Description: Participants will be contacted to complete a survey and their charts will be reviewed annually after research MRI to identify any evidence of subsequent development of pancreatic endocrine insufficiency or progression of pancreatitis. Survey and chart review will occur within +/- 14 days of the anniversary date.

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Survey Completion
Description: Participants will be contacted to complete a survey and their charts will be reviewed annually after research MRI to identify any evidence of subsequent development of pancreatic endocrine insufficiency or progression of pancreatitis. Survey and chart review will occur within +/- 14 days of the anniversary date.

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: Endoscopic pancreatic function tests (ePFTs)
Description: At least two duodenal fluid aspirates will be collected over 15 minutes following secretin administration. Aspirates will be immediately pH tested and will be submitted for analysis of bicarbonate, enzyme (trypsin, amylase, lipase, chymotrypsin) activity, and total protein.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Secretin
Description: Participants enrolled in Aim 1, Aim 3, and Aim 4 will receive intravenous secretin at a dose of 0.2 mcg/kg (maximum 16 mcg).~Participants in Aim 1 will receive two doses (1 during endoscopy and 1 during MRI). Participants in Aim 3 will receive one dose during MRI.~Participants in Aim 4 will receive two doses (1 during each MRI).~Secretin for intravenous use is FDA-approved for stimulation of pancreatic secretions, including bicarbonate, to aid in the diagnosis of exocrine pancreas dysfunction. Safety and effectiveness of secretin in pediatrics have not been established. However, secretin is routinely used in children at CCHMC at the same dose at which it will be administered for this study.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Secretin
Description: Participants enrolled in Aim 1, Aim 3, and Aim 4 will receive intravenous secretin at a dose of 0.2 mcg/kg (maximum 16 mcg).~Participants in Aim 1 will receive two doses (1 during endoscopy and 1 during MRI). Participants in Aim 3 will receive one dose during MRI.~Participants in Aim 4 will receive two doses (1 during each MRI).~Secretin for intravenous use is FDA-approved for stimulation of pancreatic secretions, including bicarbonate, to aid in the diagnosis of exocrine pancreas dysfunction. Safety and effectiveness of secretin in pediatrics have not been established. However, secretin is routinely used in children at CCHMC at the same dose at which it will be administered for this study.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Secretin
Description: Participants enrolled in Aim 1, Aim 3, and Aim 4 will receive intravenous secretin at a dose of 0.2 mcg/kg (maximum 16 mcg).~Participants in Aim 1 will receive two doses (1 during endoscopy and 1 during MRI). Participants in Aim 3 will receive one dose during MRI.~Participants in Aim 4 will receive two doses (1 during each MRI).~Secretin for intravenous use is FDA-approved for stimulation of pancreatic secretions, including bicarbonate, to aid in the diagnosis of exocrine pancreas dysfunction. Safety and effectiveness of secretin in pediatrics have not been established. However, secretin is routinely used in children at CCHMC at the same dose at which it will be administered for this study.