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

NCT02244164 | Terminated

• 1 other identifier: Incretine study
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type 2 Diabetes; Incretinomimetics; Pancreas

Keywords

Type 2 Diabetes; Incretinomimetics; DPP-4 inhibitors; Pancreas; PanIN; RMN; Lipasemia

Outcome Measures

Primary Outcomes (1)

• Volumetric measurement of the pancreas

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

  1 year

Secondary Outcomes (1)

• Quantitative response to secretin

  1 year

Other Outcomes (14)

• Fasting glycemia

  1 year

• C-Peptide

  1 years

• HbA1c

  1 year

Study Arms (3)

Sulfonylurea

ACTIVE COMPARATOR

Patient will received metformine with sulfonylurea

Drug: Incretinomimetics; Drug: DPP-4 inhibitors

Incretinomimectics

ACTIVE COMPARATOR

Patients will received metformin with sulfonylurea with GLP-1 analogue

Drug: DPP-4 inhibitors

DPP-4 inhibitors

ACTIVE COMPARATOR

Patients will received metformin with DPP-4 inhibitors

Drug: Incretinomimetics

Interventions

Incretinomimetics DRUG

Also known as: - exenatide (Byetta®), - liraglutide (Victoza®), - lixisenatide (Lyxumia®), - exenatide extended-release (Bydureon®).

DPP-4 inhibitors; Sulfonylurea

DPP-4 inhibitors DRUG

Also known as: - sitagliptine (Januvia®), - vildagliptine (Galvus®), - saxagliptine (Onglyza®), - linagliptine (Trajenta®).

Incretinomimectics; Sulfonylurea

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Erasme University Hospital: lead

Study Sites (1)

Gastroenterology Department Erasme Hospital

Brussels, 1070, Belgium

Location

Related Publications (4)

• Drucker DJ, Nauck MA. The incretin system: glucagon-like peptide-1 receptor agonists and dipeptidyl peptidase-4 inhibitors in type 2 diabetes. Lancet. 2006 Nov 11;368(9548):1696-705. doi: 10.1016/S0140-6736(06)69705-5.

  PMID: 17098089 RESULT

• Amori RE, Lau J, Pittas AG. Efficacy and safety of incretin therapy in type 2 diabetes: systematic review and meta-analysis. JAMA. 2007 Jul 11;298(2):194-206. doi: 10.1001/jama.298.2.194.

  PMID: 17622601 RESULT

• Butler 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 RESULT

• Butler 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 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Exenatide; Liraglutide; lixisenatide; Dipeptidyl-Peptidase IV Inhibitors; Sitagliptin Phosphate; Vildagliptin; saxagliptin; Linagliptin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Peptides; Amino Acids, Peptides, and Proteins; Venoms; Complex Mixtures; Toxins, Biological; Biological Factors; Glucagon-Like Peptide 1; Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Protease Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Hypoglycemic Agents; Physiological Effects of Drugs; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines; Nitriles; Organic Chemicals; Pyrrolidines; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Quinazolines

Study Officials

• Vincent Huberty, MD

  Gastroenterology Department Erasme Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2014
• First Posted: September 18, 2014
• Study Start: October 1, 2014
• Primary Completion: February 13, 2023
• Study Completion: February 13, 2023
• Last Updated: February 16, 2023

Record last verified: 2023-02

Locations

BE (1)