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

Recruiting

• Conditions: Diabetes Mellitus
• Interventions: Other: No intervention

• Registration Number: NCT06150690
• Lead Sponsor: German Diabetes Center

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.

Study Timeline

• Study Start: 2012-08-21
• Study First Submitted: 2019-09-12
• Status Verified: 2023-11
• Study First Submitted QC: 2023-11-27
• Last Update Submitted: 2023-11-27
• Study First Posted: 2023-11-29
• Last Update Posted: 2023-11-29
• Primary Completion: 2030-12-31
• Study Completion: 2035-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

ability to give informed consent

Exclusion Criteria

denial of informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Non-diabetic controls	No intervention	Patients with normal glucose metabolism undergoing (partial) pancreatectomy
Type 2 diabetes	No intervention	Patients with type 2 diabetes undergoing (partial) pancreatectomy
Type 3 diabetes	No intervention	Patients with type 3 diabetes undergoing (partial) pancreatectomy

Primary Outcome Measures

Name	Time	Method
Glycated hemoglobin	1 year	Proportion of glycated HbA1c (in %) as determined from pre-operative serum samples

Secondary Outcome Measures

Name	Time	Method
Islet area	1 year	Size of pancreatic islets of Langerhans (in square micrometers) as determined by microscopic/morphometric analyses of appropriately stained thin sections of pancreatic tissue samples

Trial Locations

Locations (1)

German Diabetes Center; 🇩🇪 Düsseldorf, NRW, Germany