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NCT Number: NCT06150690

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

German Diabetes Center

Düsseldorf, North Rhine-Westphalia, 40225, Germany

Location status: Recruiting

Location contact

Volker Burkart, PhD

CONTACT

[email protected]

+49-211-3382 ext. 641

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

ability to give informed consent

Exclusion criteria

denial of informed consent

Treatment and study plan

No intervention

Other

The participants did not receive any study-specific intervention

Primary outcomes

  1. Glycated hemoglobin

    Time frame: 1 year

    Proportion of glycated HbA1c (in %) as determined from pre-operative serum samples

Secondary outcomes

  1. Islet area

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Volker Burkart, PhD

CONTACT

[email protected]

+49-211-3382 ext. 641

Sponsors and collaborators

Lead sponsor

German Diabetes Center

Other

Collaborators

  • Florence Nightingale Hospital, Düsseldorf, Germany
  • Heinrich-Heine University, Duesseldorf
  • Lukas Hospital, Neuss, Germany

Registry information

Official study title

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

Acronym: PRECISE

Important dates

Study start
2012
Primary completion
2030
Study completion
2035
First posted
Nov 29, 2023
Registry last updated
Nov 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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