NCT06150690

Study on Pancreatic Islets in Patients Undergoing (Partial) Pancreatectomy (PRECISE)

Study on the Function of Insulin-producing Beta Cells in the Human Pancreas

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 400 (estimated)
• Sponsor: German Diabetes Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study investigates the mechanisms underlying the pathogenesis of diabetes by examining structural and functional properties of islets of Langerhans in pancreas specimen from patients undergoing (partial) pancreatectomy.

Detailed description

The study aims at elucidating the mechanisms underlying the pathogenesis of diabetes. In particular, the study focusses on detailed analyses of morphological and functional properties of pancreatic islets/insulin-producing beta cells in order to identify diabetes-associated alterations on cellular and molecular levels. To directly address the role of the endocrine (and exocrine) pancreas in the complex process of diabetes development, the examinations are performed in samples of human pancreatic tissue. To this end, biopsy specimen of pancreas and visceral adipose tissue are collected from patients with or without diabetes who undergo (partial) pancreatectomy. The samples are analysed for morphological alterations (e.g. size and distribution of pancreatic islets and beta cells, size of adipocytes) and functional changes (e.g. gene expression patterns as assessed from beta-cell derived RNA). In addition, patient characteristics such as age and disease duration are documented and clinical data including fasting concentrations of blood glucose, insulin and free fatty acids are collected. Specific diabetes-associated alterations of pancreatic islet / beta cells are assessed by associating variables of glucose- and lipid-homeostasis with parameters of beta cell function. The expected outcomes of the study will contribute to improve our knowledge of the so far largely unknown molecular and cellular mechanisms involved in the pathogenesis of diabetes.

Conditions

• Diabetes Mellitus

Interventions

Type	Name	Description
OTHER	No intervention	The participants did not receive any study-specific intervention

Timeline

• Start date: 2012-08-21
• Primary completion: 2030-12-31
• Completion: 2035-12-31
• First posted: 2023-11-29
• Last updated: 2023-11-29

Locations

1 site across 1 country: Germany