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CompletedNCT03396146DIAPPUpdated Jan 15, 2026

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

An interventional study of 12 ml total blood tubes volume and Fecal sample in Type1diabetes, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-15.

Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
36
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Type1diabetes

Keywords

  • Pancreatic polypeptide
  • Type 1 diabetes
  • Chronic pancreatitis
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

Exclusion Criteria:

  • Pregnancy
  • Severe renal impairment (eDFG \<45 mL / min / 1.73 m²)
04

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
36 participants (actual)

Study arms

  • Experimental
    Type1diabetes with exocrine pancreatic function insufficiency

    12 ml total blood tubes volume Fecal sample

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

  • Experimental
    Type1diabetes without exocrine pancreatic function insuficienc

    12 ml total blood tubes volume Fecal sample

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

  • Active comparator
    Type 3c diabetes

    12 ml total blood tubes volume Fecal sample

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

Interventions

  • Other12 ml total blood tubes volume

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

  • OtherFecal sample

    Fecal sample at inclusion

05

What researchers measure

Primary outcomes

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

    physiological parameters

    Time frame: 1 day

Secondary outcomes

  1. Measurement of C-peptide levels

    physiological parameters

    Time frame: 1 day

  2. Measurement of fecal elastase level

    physiological parameters

    Time frame: at inclusion

06

Study locations

1 site
  • Cochin Hospital
    Paris, Paris 75014, France
07

References and documents

Publications

  • Larger E, Philippe MF, Barbot-Trystram L, Radu A, Rotariu M, Nobecourt E, Boitard C. Pancreatic exocrine function in patients with diabetes. Diabet Med. 2012 Aug;29(8):1047-54. doi: 10.1111/j.1464-5491.2012.03597.x. PubMed 22273174 ↗
  • Philippe MF, Benabadji S, Barbot-Trystram L, Vadrot D, Boitard C, Larger E. Pancreatic volume and endocrine and exocrine functions in patients with diabetes. Pancreas. 2011 Apr;40(3):359-63. doi: 10.1097/MPA.0b013e3182072032. PubMed 21283038 ↗
  • Rickels MR, Bellin M, Toledo FG, Robertson RP, Andersen DK, Chari ST, Brand R, Frulloni L, Anderson MA, Whitcomb DC; PancreasFest Recommendation Conference Participants. Detection, evaluation and treatment of diabetes mellitus in chronic pancreatitis: recommendations from PancreasFest 2012. Pancreatology. 2013 Jul-Aug;13(4):336-42. doi: 10.1016/j.pan.2013.05.002. Epub 2013 May 17. PubMed 23890130 ↗
  • Khandekar N, Berning BA, Sainsbury A, Lin S. The role of pancreatic polypeptide in the regulation of energy homeostasis. Mol Cell Endocrinol. 2015 Dec 15;418 Pt 1:33-41. doi: 10.1016/j.mce.2015.06.028. Epub 2015 Jun 27. PubMed 26123585 ↗
  • Hennig R, Kekis PB, Friess H, Adrian TE, Buchler MW. Pancreatic polypeptide in pancreatitis. Peptides. 2002 Feb;23(2):331-8. doi: 10.1016/s0196-9781(01)00605-2. PubMed 11825647 ↗
  • Wang X, Zielinski MC, Misawa R, Wen P, Wang TY, Wang CZ, Witkowski P, Hara M. Quantitative analysis of pancreatic polypeptide cell distribution in the human pancreas. PLoS One. 2013;8(1):e55501. doi: 10.1371/journal.pone.0055501. Epub 2013 Jan 31. PubMed 23383206 ↗
  • Simonian HP, Kresge KM, Boden GH, Parkman HP. Differential effects of sham feeding and meal ingestion on ghrelin and pancreatic polypeptide levels: evidence for vagal efferent stimulation mediating ghrelin release. Neurogastroenterol Motil. 2005 Jun;17(3):348-54. doi: 10.1111/j.1365-2982.2004.00634.x. PubMed 15916622 ↗
  • Veedfald S, Plamboeck A, Hartmann B, Svendsen LB, Vilsboll T, Knop FK, Holst JJ. Pancreatic polypeptide responses to isoglycemic oral and intravenous glucose in humans with and without intact vagal innervation. Peptides. 2015 Sep;71:229-31. doi: 10.1016/j.peptides.2015.07.020. Epub 2015 Jul 26. PubMed 26218807 ↗
  • Batterham RL, Le Roux CW, Cohen MA, Park AJ, Ellis SM, Patterson M, Frost GS, Ghatei MA, Bloom SR. Pancreatic polypeptide reduces appetite and food intake in humans. J Clin Endocrinol Metab. 2003 Aug;88(8):3989-92. doi: 10.1210/jc.2003-030630. PubMed 12915697 ↗
  • Brunicardi FC, Chaiken RL, Ryan AS, Seymour NE, Hoffmann JA, Lebovitz HE, Chance RE, Gingerich RL, Andersen DK, Elahi D. Pancreatic polypeptide administration improves abnormal glucose metabolism in patients with chronic pancreatitis. J Clin Endocrinol Metab. 1996 Oct;81(10):3566-72. doi: 10.1210/jcem.81.10.8855802. PubMed 8855802 ↗
  • Rabiee A, Galiatsatos P, Salas-Carrillo R, Thompson MJ, Andersen DK, Elahi D. Pancreatic polypeptide administration enhances insulin sensitivity and reduces the insulin requirement of patients on insulin pump therapy. J Diabetes Sci Technol. 2011 Nov 1;5(6):1521-8. doi: 10.1177/193229681100500629. PubMed 22226275 ↗
  • Henquin JC, Rahier J. Pancreatic alpha cell mass in European subjects with type 2 diabetes. Diabetologia. 2011 Jul;54(7):1720-5. doi: 10.1007/s00125-011-2118-4. Epub 2011 Apr 5. PubMed 21465328 ↗
  • Diedisheim M, Mallone R, Boitard C, Larger E. beta-cell Mass in Nondiabetic Autoantibody-Positive Subjects: An Analysis Based on the Network for Pancreatic Organ Donors Database. J Clin Endocrinol Metab. 2016 Apr;101(4):1390-7. doi: 10.1210/jc.2015-3756. Epub 2016 Feb 1. PubMed 26829442 ↗
  • Gerich JE, Langlois M, Noacco C, Karam JH, Forsham PH. Lack of glucagon response to hypoglycemia in diabetes: evidence for an intrinsic pancreatic alpha cell defect. Science. 1973 Oct 12;182(4108):171-3. doi: 10.1126/science.182.4108.171. PubMed 4581053 ↗
  • Lund A, Bagger JI, Wewer Albrechtsen NJ, Christensen M, Grondahl M, Hartmann B, Mathiesen ER, Hansen CP, Storkholm JH, van Hall G, Rehfeld JF, Hornburg D, Meissner F, Mann M, Larsen S, Holst JJ, Vilsboll T, Knop FK. Evidence of Extrapancreatic Glucagon Secretion in Man. Diabetes. 2016 Mar;65(3):585-97. doi: 10.2337/db15-1541. Epub 2015 Dec 15. PubMed 26672094 ↗
  • Tiengo A, Bessioud M, Valverde I, Tabbi-Anneni A, Delprato S, Alexandre J, Assan R. Absence of islet alpha cell function in pancreatectomized patients. Diabetologia. 1982 Jan;22(1):25-32. doi: 10.1007/BF00253865. PubMed 6120875 ↗
  • Haldorsen IS, Raeder H, Vesterhus M, Molven A, Njolstad PR. The role of pancreatic imaging in monogenic diabetes mellitus. Nat Rev Endocrinol. 2011 Nov 29;8(3):148-59. doi: 10.1038/nrendo.2011.197. PubMed 22124438 ↗
  • Bellanne-Chantelot C, Chauveau D, Gautier JF, Dubois-Laforgue D, Clauin S, Beaufils S, Wilhelm JM, Boitard C, Noel LH, Velho G, Timsit J. Clinical spectrum associated with hepatocyte nuclear factor-1beta mutations. Ann Intern Med. 2004 Apr 6;140(7):510-7. doi: 10.7326/0003-4819-140-7-200404060-00009. PubMed 15068978 ↗
  • Andersen BN, Hagen C, Klein HC, Stadil F, Worning H. Correlation between exocrine pancreatic secretion and serum concentration of human pancreatic polypeptide in chronic pancreatitis. Scand J Gastroenterol. 1980;15(6):699-704. doi: 10.3109/00365528009181517. PubMed 7209380 ↗
  • Matsumoto M, Wakasugi H, Ibayashi H. Plasma human pancreatic polypeptide response in chronic pancreatitis. Gastroenterol Jpn. 1982;17(1):25-30. doi: 10.1007/BF02774757. PubMed 7042449 ↗
  • Vu MK, Vecht J, Eddes EH, Biemond I, Lamers CB, Masclee AA. Antroduodenal motility in chronic pancreatitis: are abnormalities related to exocrine insufficiency? Am J Physiol Gastrointest Liver Physiol. 2000 Mar;278(3):G458-66. doi: 10.1152/ajpgi.2000.278.3.G458. PubMed 10712266 ↗
  • Sobngwi E, Boudou P, Mauvais-Jarvis F, Leblanc H, Velho G, Vexiau P, Porcher R, Hadjadj S, Pratley R, Tataranni PA, Calvo F, Gautier JF. Effect of a diabetic environment in utero on predisposition to type 2 diabetes. Lancet. 2003 May 31;361(9372):1861-5. doi: 10.1016/S0140-6736(03)13505-2. PubMed 12788573 ↗
  • Chia CW, Odetunde JO, Kim W, Carlson OD, Ferrucci L, Egan JM. GIP contributes to islet trihormonal abnormalities in type 2 diabetes. J Clin Endocrinol Metab. 2014 Jul;99(7):2477-85. doi: 10.1210/jc.2013-3994. Epub 2014 Apr 8. PubMed 24712564 ↗
  • Belinova L, Kahleova H, Malinska H, Topolcan O, Vrzalova J, Oliyarnyk O, Kazdova L, Hill M, Pelikanova T. Differential acute postprandial effects of processed meat and isocaloric vegan meals on the gastrointestinal hormone response in subjects suffering from type 2 diabetes and healthy controls: a randomized crossover study. PLoS One. 2014 Sep 15;9(9):e107561. doi: 10.1371/journal.pone.0107561. eCollection 2014. PubMed 25222490 ↗
  • Hart PA, Baichoo E, Bi Y, Hinton A, Kudva YC, Chari ST. Pancreatic polypeptide response to a mixed meal is blunted in pancreatic head cancer associated with diabetes mellitus. Pancreatology. 2015 Mar-Apr;15(2):162-6. doi: 10.1016/j.pan.2015.02.006. Epub 2015 Feb 24. PubMed 25766398 ↗
  • Sumithran P, Prendergast LA, Delbridge E, Purcell K, Shulkes A, Kriketos A, Proietto J. Long-term persistence of hormonal adaptations to weight loss. N Engl J Med. 2011 Oct 27;365(17):1597-604. doi: 10.1056/NEJMoa1105816. PubMed 22029981 ↗
  • Nealon WH, Townsend CM Jr, Thompson JC. The time course of beta cell dysfunction in chronic ethanol-induced pancreatitis: a prospective analysis. Surgery. 1988 Dec;104(6):1074-9. PubMed 3057670 ↗
  • Brunicardi FC, Druck P, Sun YS, Elahi D, Gingerich RL, Andersen DK. Regulation of pancreatic polypeptide secretion in the isolated perfused human pancreas. Am J Surg. 1988 Jan;155(1):63-9. doi: 10.1016/s0002-9610(88)80259-9. PubMed 3277467 ↗
  • Dehghani L, Bonnet-Serrano F, Abdul H, Alexandre-Heymann L, Guibourdenche J, Larger E. Pancreatic polypeptide in patients with type 1 diabetes and exocrine failure or chronic pancreatitis. The DIAPP study. Diabetes Metab. 2026 Jan;52(1):101712. doi: 10.1016/j.diabet.2025.101712. Epub 2025 Nov 9. PubMed 41218735 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03396146
Lead sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Cochin Hospital's Hormonology Laboratory, URC-CIC Paris Descartes Necker Cochin
Responsible party
Sponsor
First posted
Jan 10, 2018
Start date
Jun 14, 2018
Primary completion
Dec 18, 2019
Completion
Dec 18, 2019
Last update
Jan 15, 2026

Study contacts

Etienne LARGER, MD, PhD
study chair · Assistance Publique - Hôpitaux de Paris

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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