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

Sponsor
Assistance Publique - Hôpitaux de Paris (Other)
Overall Status
Completed
CT.gov ID
NCT03396146
Collaborator
Cochin Hospital's Hormonology Laboratory (Other)
36
Enrollment
1
Location
3
Arms
18.1
Actual Duration (Months)
2
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: 12 ml total blood tubes volume
  • Other: Fecal sample
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
36 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Assay for the Pancreatic Polypeptide: an Help for Clinical Practice Guidelines in Classification of the Diabetes
Actual Study Start Date :
Jun 14, 2018
Actual Primary Completion Date :
Dec 18, 2019
Actual Study Completion Date :
Dec 18, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Measurement of pancreatic polypeptide for calculating the area under the curve [1 day]

    physiological parameters

Secondary Outcome Measures

  1. Measurement of C-peptide levels [1 day]

    physiological parameters

  2. Measurement of fecal elastase level [at inclusion]

    physiological parameters

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Cochin Hospital Paris France 75014

Sponsors and Collaborators

  • Assistance Publique - Hôpitaux de Paris
  • Cochin Hospital's Hormonology Laboratory

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT03396146
Other Study ID Numbers:
  • K160403J
  • 2017-A00612-51
First Posted:
Jan 10, 2018
Last Update Posted:
Apr 19, 2021
Last Verified:
Apr 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Assistance Publique - Hôpitaux de Paris
Pancreatic polypeptide
Type 1 diabetes
Chronic pancreatitis
Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1

Study Results

No Results Posted as of Apr 19, 2021