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

Primary Purpose

Type1diabetes

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
12 ml total blood tubes volume
Fecal sample
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Type1diabetes focused on measuring Pancreatic polypeptide, Type 1 diabetes, Chronic pancreatitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Cochin Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Type1diabetes with exocrine pancreatic function insufficiency

Type1diabetes without exocrine pancreatic function insuficienc

Type 3c diabetes

Arm Description

12 ml total blood tubes volume Fecal sample

12 ml total blood tubes volume Fecal sample

12 ml total blood tubes volume Fecal sample

Outcomes

Primary Outcome Measures

Measurement of pancreatic polypeptide for calculating the area under the curve
physiological parameters

Secondary Outcome Measures

Measurement of C-peptide levels
physiological parameters
Measurement of fecal elastase level
physiological parameters

Full Information

First Posted
November 17, 2017
Last Updated
April 16, 2021
Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Cochin Hospital's Hormonology Laboratory
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1. Study Identification

Unique Protocol Identification Number
NCT03396146
Brief Title
Assay for the Pancreatic Polypeptide: an Help for Clinical Practice Guidelines in Classification of the Diabetes
Acronym
DIAPP
Official Title
Assay for the Pancreatic Polypeptide: an Help for Clinical Practice Guidelines in Classification of the Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
June 14, 2018 (Actual)
Primary Completion Date
December 18, 2019 (Actual)
Study Completion Date
December 18, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Cochin Hospital's Hormonology Laboratory

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate global endocrine function within type 1 and type 3c diabetic patients, helping pancreatic polypeptide measurement.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type1diabetes
Keywords
Pancreatic polypeptide, Type 1 diabetes, Chronic pancreatitis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Type1diabetes with exocrine pancreatic function insufficiency
Arm Type
Experimental
Arm Description
12 ml total blood tubes volume Fecal sample
Arm Title
Type1diabetes without exocrine pancreatic function insuficienc
Arm Type
Experimental
Arm Description
12 ml total blood tubes volume Fecal sample
Arm Title
Type 3c diabetes
Arm Type
Active Comparator
Arm Description
12 ml total blood tubes volume Fecal sample
Intervention Type
Other
Intervention Name(s)
12 ml total blood tubes volume
Intervention Description
12 ml total blood tubes at 0, +60, + 90, + 120 minutes before and after a mixed meal
Intervention Type
Other
Intervention Name(s)
Fecal sample
Intervention Description
Fecal sample at inclusion
Primary Outcome Measure Information:
Title
Measurement of pancreatic polypeptide for calculating the area under the curve
Description
physiological parameters
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Measurement of C-peptide levels
Description
physiological parameters
Time Frame
1 day
Title
Measurement of fecal elastase level
Description
physiological parameters
Time Frame
at inclusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Etienne LARGER, MD, PhD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Study Chair
Facility Information:
Facility Name
Cochin Hospital
City
Paris
ZIP/Postal Code
75014
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
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Assay for the Pancreatic Polypeptide: an Help for Clinical Practice Guidelines in Classification of the Diabetes

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