Clinical trial NCT06150690: Study on Pancreatic Islets in Patients Undergoing (Partial) Pancreatectomy (PRECISE)
Official title: Study on the Function of Insulin-producing Beta Cells in the Human Pancreas
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Diabetes Mellitus
Lead sponsor: German Diabetes Center
Sponsor class: OTHER
Collaborators: name: Lukas Hospital, Neuss, Germany
name: Heinrich-Heine University, Duesseldorf
name: Florence Nightingale Hospital, Düsseldorf, Germany
First posted: 2023-11-29
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with or without diabetes who undergo (partial) pancreatectomy

Brief 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.

Eligibility criteria: Inclusion Criteria:

ability to give informed consent

Exclusion Criteria:

denial of informed consent

Primary outcomes:
measure: Glycated hemoglobin
timeFrame: 1 year
Secondary outcomes:
measure: Islet area
timeFrame: 1 year
Other outcomes:
Locations:
city: Düsseldorf
country: Germany
facility: German Diabetes Center
state: NRW
Study officials:
affiliation: German Diabetes Center
name: Michael Roden, Prof MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Böddeker J-S, Burkart V, Strassburger K, Goretzki P, Knoefel W-T, Möbius C, Bug R, Hinsch N, Esposito I, Gerharz CD, Roden M, Müssig K. Diabetes in Patients with Pancreatic Cancer: Relationship of Tumor Grade with Glycemic Control. Diabetes 2019; 68 (Suppl 1) DOI: https://doi.org/10.2337/db19-434-P