Study on Pancreatic Islets in Patients Undergoing (Partial) Pancreatectomy (PRECISE)
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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 Design
Arms and Interventions
| Arm | 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
|
Outcome Measures
Primary Outcome Measures
- Glycated hemoglobin [1 year]
Proportion of glycated HbA1c (in %) as determined from pre-operative serum samples
Secondary Outcome Measures
- Islet area [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
Eligibility Criteria
Criteria
Inclusion Criteria:
ability to give informed consent
Exclusion Criteria:
denial of informed consent
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | German Diabetes Center | Düsseldorf | NRW | Germany | 40225 |
Sponsors and Collaborators
- German Diabetes Center
- Lukas Hospital, Neuss, Germany
- Heinrich-Heine University, Duesseldorf
- Florence Nightingale Hospital, Düsseldorf, Germany
Investigators
- Principal Investigator: Michael Roden, Prof MD, German Diabetes Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Pancreatic-Islet-Study-01