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

Diabetes Mellitus Clinical Trial

— PRECISE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06150690
• Other study ID #: Pancreatic-Islet-Study-01
• Status: Recruiting
• Start date: August 21, 2012
• Est. completion date: December 31, 2035

Study information

• Verified date: November 2023
• Source: German Diabetes Center
• Contact: Volker Burkart, PhD
• Phone: +49-211-3382
• Email: volker.burkart[@]ddz.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 31, 2035
• Est. primary completion date: December 31, 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

ability to give informed consent

Exclusion Criteria:

denial of informed consent

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

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

Locations

Country	Name	City	State
Germany	German Diabetes Center	Düsseldorf	NRW

Sponsors (4)

Lead Sponsor	Collaborator
German Diabetes Center	Florence Nightingale Hospital, Düsseldorf, Germany, Heinrich-Heine University, Duesseldorf, Lukas Hospital, Neuss, Germany

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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 (Supp

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycated hemoglobin	Proportion of glycated HbA1c (in %) as determined from pre-operative serum samples	1 year
Secondary	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