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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06150690
Acronym
PRECISE
Enrollment
400
Registered
2023-11-29
Start date
2012-08-21
Completion date
2035-12-31
Last updated
2023-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus

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.

Interventions

OTHERNo intervention

The participants did not receive any study-specific intervention

Sponsors

Lukas Hospital, Neuss, Germany
CollaboratorUNKNOWN
Heinrich-Heine University, Duesseldorf
CollaboratorOTHER
Florence Nightingale Hospital, Düsseldorf, Germany
CollaboratorUNKNOWN
German Diabetes Center
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

ability to give informed consent

Exclusion criteria

denial of informed consent

Design outcomes

Primary

MeasureTime frameDescription
Glycated hemoglobin1 yearProportion of glycated HbA1c (in %) as determined from pre-operative serum samples

Secondary

MeasureTime frameDescription
Islet area1 yearSize of pancreatic islets of Langerhans (in square micrometers) as determined by microscopic/morphometric analyses of appropriately stained thin sections of pancreatic tissue samples

Countries

Germany

Contacts

Primary ContactVolker Burkart, PhD
volker.burkart@ddz.de+49-211-3382

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026