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

NCT ID: NCT06150690

Last Updated: 2023-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-08-21

Study Completion Date

2035-12-31

Brief Summary

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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

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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.

Conditions

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Diabetes Mellitus

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Type 2 diabetes

Patients with type 2 diabetes undergoing (partial) pancreatectomy

No intervention

Intervention Type OTHER

The participants did not receive any study-specific intervention

Type 3 diabetes

Patients with type 3 diabetes undergoing (partial) pancreatectomy

No intervention

Intervention Type OTHER

The participants did not receive any study-specific intervention

Non-diabetic controls

Patients with normal glucose metabolism undergoing (partial) pancreatectomy

No intervention

Intervention Type OTHER

The participants did not receive any study-specific intervention

Interventions

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No intervention

The participants did not receive any study-specific intervention

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

ability to give informed consent

Exclusion Criteria

denial of informed consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Lukas Hospital, Neuss, Germany

UNKNOWN

Sponsor Role collaborator

Heinrich-Heine University, Duesseldorf

OTHER

Sponsor Role collaborator

Florence Nightingale Hospital, Düsseldorf, Germany

UNKNOWN

Sponsor Role collaborator

German Diabetes Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael Roden, Prof MD

Role: PRINCIPAL_INVESTIGATOR

German Diabetes Center

Locations

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German Diabetes Center

Düsseldorf, North Rhine-Westphalia, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Volker Burkart, PhD

Role: CONTACT

Phone: +49-211-3382

Email: [email protected]

Facility Contacts

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Volker Burkart, PhD

Role: primary

References

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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

Reference Type RESULT

Other Identifiers

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Pancreatic-Islet-Study-01

Identifier Type: -

Identifier Source: org_study_id