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Recruiting NCT06150690

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

Observational Diabetes Mellitus

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: No intervention.
Who it may be relevant to
Registry conditions: Diabetes Mellitus. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • Other No intervention
    The participants did not receive any study-specific intervention

Primary outcome measures

  • Glycated hemoglobin [Time frame: 1 year]
Secondary outcome measures (1)
  • Islet area [Time frame: 1 year]

Eligibility criteria

Inclusion criteria

ability to give informed consent

Exclusion criteria

denial of informed consent

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-control

Study locations

Germany · 1 center
  • German Diabetes Center — Düsseldorf

Publications

  • 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

Identifiers

NCT: NCT06150690 · Pancreatic-Islet-Study-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗