NCT06150690

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
116mo left

Started Aug 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress59%
Aug 2012Dec 2035

Study Start

First participant enrolled

August 21, 2012

Completed
7.1 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2019

Completed
4.2 years until next milestone

First Posted

Study publicly available on registry

November 29, 2023

Completed
7.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2030

Expected
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2035

Last Updated

November 29, 2023

Status Verified

November 1, 2023

Enrollment Period

18.4 years

First QC Date

September 12, 2019

Last Update Submit

November 27, 2023

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • Glycated hemoglobin

    Proportion of glycated HbA1c (in %) as determined from pre-operative serum samples

    1 year

Secondary Outcomes (1)

  • Islet area

    1 year

Study Arms (3)

Type 2 diabetes

Patients with type 2 diabetes undergoing (partial) pancreatectomy

Other: No intervention

Type 3 diabetes

Patients with type 3 diabetes undergoing (partial) pancreatectomy

Other: No intervention

Non-diabetic controls

Patients with normal glucose metabolism undergoing (partial) pancreatectomy

Other: No intervention

Interventions

No interventionOTHER

The participants did not receive any study-specific intervention

Non-diabetic controlsType 2 diabetesType 3 diabetes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with or without diabetes who undergo (partial) pancreatectomy

You may qualify if:

  • ability to give informed consent

You may not qualify if:

  • denial of informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

German Diabetes Center

Düsseldorf, North Rhine-Westphalia, 40225, Germany

RECRUITING

Related 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 (Suppl 1) DOI: https://doi.org/10.2337/db19-434-P

    RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

Pancreatic tissue, visceral adipose tissue and serum samples

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Michael Roden, Prof MD

    German Diabetes Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Volker Burkart, PhD

CONTACT

+49-211-3382volker.burkart@ddz.de

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2019

First Posted

November 29, 2023

Study Start

August 21, 2012

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

December 31, 2035

Last Updated

November 29, 2023

Record last verified: 2023-11

Locations

DE(1)