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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Diabetes Mellitus
• Intervention / Treatment: Other: No intervention

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 Type: Observational
• Enrollment (Estimated): 400

Contacts and Locations

• Study Contact: Name: Volker Burkart, PhD; Phone Number: 641 +49-211-3382; Email: volker.burkart@ddz.de

Study Locations

• Germany
  • NRW
    • Düsseldorf, NRW, Germany, 40225
      • Recruiting
      • German Diabetes Center
      • Contact: Volker Burkart, PhD; Phone Number: 641 +49-211-3382; Email: volker.burkart@ddz.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

patients with or without diabetes who undergo (partial) pancreatectomy

Description

Inclusion Criteria:

ability to give informed consent

Exclusion Criteria:

denial of informed consent

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Type 2 diabetes; Patients with type 2 diabetes undergoing (partial) pancreatectomy	Other: No intervention; The participants did not receive any study-specific intervention
Type 3 diabetes; Patients with type 3 diabetes undergoing (partial) pancreatectomy	Other: No intervention; The participants did not receive any study-specific intervention
Non-diabetic controls; Patients with normal glucose metabolism undergoing (partial) pancreatectomy	Other: No intervention; The participants did not receive any study-specific intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glycated hemoglobin	Proportion of glycated HbA1c (in %) as determined from pre-operative serum samples	1 year

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: German Diabetes Center
• Collaborators: Heinrich-Heine University, Duesseldorf; Lukas Hospital, Neuss, Germany; Florence Nightingale Hospital, Düsseldorf, Germany
• Investigators: Principal Investigator: Michael Roden, Prof MD, German Diabetes Center

Publications and helpful links

General 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

Study record dates

Study Major Dates

• Study Start (Actual): August 21, 2012
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2035

Study Registration Dates

• First Submitted: September 12, 2019
• First Submitted That Met QC Criteria: November 27, 2023
• First Posted (Actual): November 29, 2023

Study Record Updates

• Last Update Posted (Actual): November 29, 2023
• Last Update Submitted That Met QC Criteria: November 27, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: Pancreatic-Islet-Study-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No