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

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ClinicalTrials.gov Identifier: NCT03396146
Recruitment Status : Recruiting
First Posted : January 10, 2018
Last Update Posted : September 5, 2018
Sponsor:
Collaborator:
Cochin Hospital's Hormonology Laboratory
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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
Type1diabetes Other: 12 ml total blood tubes volume Other: Fecal sample Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 40 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 : June 14, 2018
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

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 -10, 0, +30, +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 -10, 0, +30, +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 -10, 0, +30, +60, + 90, + 120 minutes before and after a mixed meal

Other: Fecal sample
Fecal sample at inclusion




Primary Outcome Measures :
  1. Measurement of pancreatic polypeptide for calculating the area under the curve [ Time Frame: 1 day ]
    physiological parameters


Secondary Outcome Measures :
  1. Measurement of C-peptide levels [ Time Frame: 1 day ]
    physiological parameters

  2. Measurement of fecal elastase level [ Time Frame: at inclusion ]
    physiological parameters



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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03396146


Contacts
Contact: Léa DEHGHANI, MD, PhD + 33 1 58 41 39 63 lea.dehghani@aphp.fr
Contact: Christelle AUGER + 33 1 58 41 11 86 christelle.auger@aphp.fr

Locations
France
Cochin Hospital Recruiting
Paris, France, 75014
Contact: Léa DEHGHANI, MD, PhD    + 33 1 58 41 39 63    lea.dehghani@aphp.fr   
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

Publications:

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03396146     History of Changes
Other Study ID Numbers: K160403J
2017-A00612-51 ( Registry Identifier: ID-RCB )
First Posted: January 10, 2018    Key Record Dates
Last Update Posted: September 5, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
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
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Pancreatic Polypeptide
Gastrointestinal Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs