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Completed

NCT Number: NCT03396146

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

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

12 ml total blood tubes volume

Other

12 ml total blood tubes at 0, +60, + 90, + 120 minutes before and after a mixed meal

Fecal sample

Other

Fecal sample at inclusion

Primary outcomes

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

    Time frame: 1 day

    physiological parameters

Secondary outcomes

  1. Measurement of C-peptide levels

    Time frame: 1 day

    physiological parameters

  2. Measurement of fecal elastase level

    Time frame: at inclusion

    physiological parameters

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • Cochin Hospital's Hormonology Laboratory
  • URC-CIC Paris Descartes Necker Cochin

Registry information

Acronym: DIAPP

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jan 10, 2018
Registry last updated
Jan 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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