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

NCT03396146 | Completed

• 2 other identifiers: K160403J2017-A00612-51
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Type1diabetes

Keywords

Pancreatic polypeptide; Type 1 diabetes; Chronic pancreatitis

Outcome Measures

Primary Outcomes (1)

• Measurement of pancreatic polypeptide for calculating the area under the curve

  physiological parameters

  1 day

Secondary Outcomes (2)

• Measurement of C-peptide levels

  1 day

• Measurement of fecal elastase level

  at inclusion

Study Arms (3)

Type1diabetes with exocrine pancreatic function insufficiency

EXPERIMENTAL

12 ml total blood tubes volume Fecal sample

Other: 12 ml total blood tubes volume; Other: Fecal sample

Type1diabetes without exocrine pancreatic function insuficienc

EXPERIMENTAL

12 ml total blood tubes volume Fecal sample

Other: 12 ml total blood tubes volume; Other: Fecal sample

Type 3c diabetes

ACTIVE COMPARATOR

12 ml total blood tubes volume Fecal sample

Other: 12 ml total blood tubes volume; Other: Fecal sample

Interventions

Fecal sample OTHER

Fecal sample at inclusion

Type 3c diabetes; Type1diabetes with exocrine pancreatic function insufficiency; Type1diabetes without exocrine pancreatic function insuficienc

12 ml total blood tubes volume OTHER

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

Type 3c diabetes; Type1diabetes with exocrine pancreatic function insufficiency; Type1diabetes without exocrine pancreatic function insuficienc

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• URC-CIC Paris Descartes Necker Cochin: collaborator
• Assistance Publique - Hôpitaux de Paris: lead
• Cochin Hospital's Hormonology Laboratory: collaborator

Study Sites (1)

Cochin Hospital

Paris, Paris, 75014, France

Location

Related Publications (29)

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  PMID: 41218735 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Pancreatitis, Chronic

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Pancreatitis; Pancreatic Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Etienne LARGER, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2017
• First Posted: January 10, 2018
• Study Start: June 14, 2018
• Primary Completion: December 18, 2019
• Study Completion: December 18, 2019
• Last Updated: January 15, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)