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Trial · Interventional

TerminatedNot applicableRegistry data

Pathophysiological Study of the Increase in Pancreatic Volume in Type 2 Diabetes Treatments.

NCTNCT02244164 (opens ClinicalTrials.gov in a new tab)Other idIncretine study
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Terminated
Phase
Not applicable
Enrollment
5 participants (actual)
Sponsor
Erasme University Hospital · Other
Design
Not randomized · Open label (no masking)
Countries
1 country

Belgium

Start
Oct 2014
Primary completion
13 Feb 2023
Completion
13 Feb 2023
First posted
18 Sept 2014 (estimated)
Last update posted
16 Feb 2023
Conditions
Type 2 Diabetes · Incretinomimetics · Pancreas

Timeline

1 trial · 1 stopped early

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201420162018202020222024
  1. N/A

    Pathophysiological Study of the Increase in Pancreatic Volume in Type 2 Diabetes Treatments.

    NCT02244164

    Oct 2014 to 13 Feb 2023

    Terminated

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

Incretinomimetics and inhibitors of dipeptidyl peptidase-4 (DPP-4) are new treatments for diabetes. Previous retrospective studies have shown that these treatments induced an increase in pancreatic mass with potentially a risk for pancreatitis and development of precancerous lesions. The aim of our study is to provide a better understanding of the pathophysiological mechanisms of increased volume and / or pancreatic exocrine secretion when exposed to certain treatment of type 2 diabetes.

Interventions

  • IncretinomimeticsDrug
  • DPP-4 inhibitorsDrug

Arms3

  • Active comparator

    Sulfonylurea

    Patient will received metformine with sulfonylurea

  • Active comparator

    Incretinomimectics

    Patients will received metformin with sulfonylurea with GLP-1 analogue

  • Active comparator

    DPP-4 inhibitors

    Patients will received metformin with DPP-4 inhibitors

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Volumetric measurement of the pancreas

    Time frame · 1 year

    Registry description

    A RMN will be done before and 1 year after the treatment. A comparative mesure of pancreatic volume will be performed.

Secondary outcomes(1)

  1. Quantitative response to secretin

    Time frame · 1 year

    Registry description

    A RMN with injection of secretin will be done before and after the treatment. A quantitative evaluation of secretin response will be performed.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies2

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Meta-analysis (pooled) · 2007

6 results

Efficacy and safety of incretin therapy in type 2 diabetes: systematic review and meta-analysis.

Amori et al. 2007JAMAcited by 755

PMID 17622601DOI 10.1001/jama.298.2.194PUB-17622601

Full text at the publisher6 results
Publisher pageSee results (6)

More studies

1 study on this page

Indexing hint: Review · 2006

The incretin system: glucagon-like peptide-1 receptor agonists and dipeptidyl peptidase-4 inhibitors in type 2 diabetes.

Drucker et al. 2006Lancet (London, England)cited by 2,833

PMID 17098089DOI 10.1016/s0140-6736(06)69705-5PUB-17098089

Full text at the publisher
Publisher page

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • ResultButler AE, Campbell-Thompson M, Gurlo T, Dawson DW, Atkinson M, Butler PC. Marked expansion of exocrine and endocrine pancreas with incretin therapy in humans with increased exocrine pancreas dysplasia and the potential for glucagon-producing neuroendocrine tumors. Diabetes. 2013 Jul;62(7):2595-604. doi: 10.2337/db12-1686. Epub 2013 Mar 22. PMID 23524641
  • ResultButler PC, Elashoff M, Elashoff R, Gale EA. A critical analysis of the clinical use of incretin-based therapies: Are the GLP-1 therapies safe? Diabetes Care. 2013 Jul;36(7):2118-25. doi: 10.2337/dc12-2713. Epub 2013 May 3. PMID 23645885

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 75 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Type 2 diabetes inadequately controlled or intolerant to metformin * Obtaining informed consent * Aged between 18 and 70 years * BMI between 20 and 45 kg / m² Exclusion Criteria: * Contraindication to nuclear magnetic resonance (NMR): * Carrying a metallic foreign body (pacemaker, valve, intraocular equipment, clips) * Allergy to Gadolinium / Secretin * Pregnancy or breastfeeding * Contraindication to treatment with incretinomimetic: * Hypersensitivity to the active substance or to any of the excipients * Severe Gastroparesis * Severe renal impairment * History of Surgery (gastroduodenal, pancreatic or ileocecal) * Presence or history of pancreatic disease * Active alcoholism

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