Assay for the Pancreatic Polypeptide: an Help for Clinical Practice Guidelines in Classification of the Diabetes (DIAPP)

April 16, 2021 updated by: Assistance Publique - Hôpitaux de Paris
The purpose of this study is to evaluate global endocrine function within type 1 and type 3c diabetic patients, helping pancreatic polypeptide measurement.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

All diabetes are the result of endrocrine deficiency. The endocrine deficiency may be absolute, as in type 1 diabetes, considered as an elective and exclusive attack of pancreatic Beta cell, or it could be relative, as un type 2 diabetes.

More rarely, diabetes fit into a broader context of pancreatic failure, with diffuse involvement of the exocrine and endocrine function, suggesting an impairment of the whole endocrine secretion of the pancreas, affecting the entire islet of Langerhans, such as in type 3c diabetes, whose prototypes are total pancreatectomy, chronic alcoholic pancreatitis, cystic fibrosis.

The diagnostic of type 3c diabetes is not always obvious, with several clinical presentations, without biological specific disease tag. Moreover, it also appears that the common form of diabetes, type 1 and type 2, may be associated with an exocrine function deficit and with a decrease of the pancreatic volume correlated with exocrine function abnormalities, and a decrease of insulin secretion capacity. The consequences of a spread of the disease beyond the Beta cells remain uncertain, but they could be linked, as in type 3c diabetes, with severe form of hypoglycaemia, due to glucagon deficiency, or nutritional deficiency due to the exocrine deficiency.

The pancreatic polypeptide belongs to the neuropeptide Y family, it is produced by the endocrine pancreatic F cells, located in the hook and the head of the pancreas. Food intake stimulates its secretion. The role of the pancreatic polypeptide in human is uncertain.

Investigators propose to study the pancreatic polypeptide in type 1 and type 3c diabetes before and after a mixed meal in order to study the other endocrine functions of the islet of Langerhans, to evaluate the possibility, or not, of a more diffuse pancreatic involvement in type 1 diabetes, considered as an elective pathology of the pancreatic Beta cell.

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75014
        • Cochin Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients aged 18 years or older
  • Patients with type 1 diabetes with anti-GAD and / or IA2 and / or Znt8 positive antibodies, or characteristic clinical history, with and without exocrine deficiency (*)
  • Patients with chronic alcoholic pancreatitis or cystic fibrosis origin (type 3c diabetes), complicated with diabetes defined by HbA1c> 6.5% or treated with oral anti-diabetic and / or insulin
  • Patients who have given informed and written consent to participate in research
  • Patients affiliated to a social security scheme (*): The exocrine deficiency is defined by an assay of fecal elastase:
  • without deficit of exocrine function = fecal elastase = /> 100 μg / g
  • with deficit of exocrine function = fecal elastase <100 μg / g

Exclusion Criteria:

  • Pregnancy
  • Severe renal impairment (eDFG <45 mL / min / 1.73 m²)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Type1diabetes with exocrine pancreatic function insufficiency
12 ml total blood tubes volume Fecal sample
Other: 12 ml total blood tubes volume
12 ml total blood tubes at 0, +60, + 90, + 120 minutes before and after a mixed meal
Other: Fecal sample
Fecal sample at inclusion
Experimental: Type1diabetes without exocrine pancreatic function insuficienc
12 ml total blood tubes volume Fecal sample
Other: 12 ml total blood tubes volume
12 ml total blood tubes at 0, +60, + 90, + 120 minutes before and after a mixed meal
Other: Fecal sample
Fecal sample at inclusion
Active Comparator: Type 3c diabetes
12 ml total blood tubes volume Fecal sample
Other: 12 ml total blood tubes volume
12 ml total blood tubes at 0, +60, + 90, + 120 minutes before and after a mixed meal
Other: Fecal sample
Fecal sample at inclusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement of pancreatic polypeptide for calculating the area under the curve
Time Frame: 1 day
physiological parameters
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement of C-peptide levels
Time Frame: 1 day
physiological parameters
1 day
Measurement of fecal elastase level
Time Frame: at inclusion
physiological parameters
at inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

Cochin Hospital's Hormonology Laboratory

Investigators

  • Study Chair: Etienne LARGER, MD, PhD, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 14, 2018

Primary Completion (Actual)

December 18, 2019

Study Completion (Actual)

December 18, 2019

Study Registration Dates

First Submitted

November 17, 2017

First Submitted That Met QC Criteria

January 4, 2018

First Posted (Actual)

January 10, 2018

Study Record Updates

Last Update Posted (Actual)

April 19, 2021

Last Update Submitted That Met QC Criteria

April 16, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • K160403J
  • 2017-A00612-51 (Registry Identifier: ID-RCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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