- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02131675
Detection of C-peptide in Youth With Longstanding Type 1 Diabetes Mellitus
2. maj 2014 opdateret af: Icahn School of Medicine at Mount Sinai
Observational Study of C-peptide Levels in Youth With Longstanding Type 1 Diabetes Mellitus as Detected by an Ultrasensitive Assay
Background Type 1 diabetes is characterized by pancreatic beta-cell destruction and an inability to synthesize insulin.
Connecting peptide (C-peptide) is formed from the same precursor as insulin and is produced in equimolar amounts as insulin.
There are several clinical trials currently being performed to explore the possibility of beta-cell preservation or regeneration.
Most children are not eligible for these trials because it is often presumed that C-peptide levels will decrease and become undetectable after years of having type 1 diabetes.
Several studies in the adult population have demonstrated that C-peptide may remain measureable in patients who have had diabetes for up to 50 years after diagnosis.
Recently, it was demonstrated that 10% of adult patients who have had type 1 diabetes for 31-40 years have measureable levels of serum C-peptide if measured with an ultrasensitive assay.
The levels were lower in patients who had diabetes for a longer time.
This pattern was also demonstrated in the Diabetes Control and Complications Trial (DCCT) and NHANES trial.
No studies have been performed exclusively in pediatric patients Hypothesis The investigators hypothesize that C-peptide should be detectable in the sera of pediatric patients who have had type 1 diabetes for greater than 1 year and as far out as > 20 years after diagnosis.
The investigators also hypothesize that since their patient population has had diabetes for less time as compared to adults, the levels of C-peptide should be higher than reported for adults and that a greater proportion of patients in the pediatric population will have detectable C-peptide levels as compared to adults.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
1) Objectives:
- To determine if C-peptide is detectable in the sera of children that have had type 1 diabetes for more than 1 year using an ultrasensitive assay.
- To correlate C-peptide levels with duration since diagnosis, current age, antibody titers at diagnosis, hemoglobin A1c, total daily insulin dosage.
- To determine responsiveness of residual C-peptide to mixed-meal testing.
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
50
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
New York
-
New York, New York, Forenede Stater, 11103
- Icahn School of Medicine at Mount Sinai
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
1 år til 21 år (Barn, Voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Subjects will be recruited from the population of patients seen in the Division of Pediatric Endocrinology and Diabetes.
These patients must have type 1 diabetes and must have been diagnosed more than 1 year prior to their recruitment.
Potential subjects will be identified by reaching out to the physicians in the division and asking that they inform the investigators of patients that they see with type 1 diabetes.
Those patients will have their information reviewed by the investigators using EPIC, the electronic medical record at The Mount Sinai Hospital.
Beskrivelse
Inclusion Criteria:
- Male or female
- 1-25 years of age
- Have had type 1 diabetes for more than 1 year.
Exclusion Criteria:
- Does not meet inclusion criteria
- Foster children
- Patients without primary caregiver
- Pregnant
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
Boost shake
children that have had type 1 diabetes for more than 1 year
|
Blood draw after mixed-meal consumption
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
C-peptide level
Tidsramme: Day 1
|
Day 1
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Hemoglobin A1c
Tidsramme: Day 1
|
Hemoglobin A1c at diabetes diagnosis and at most recent medical visit will be correlated with C-peptide level
|
Day 1
|
|
Total daily dose of insulin
Tidsramme: Day 1
|
Total daily dose of insulin per kilogram will be correlated with C-peptide level
|
Day 1
|
|
Age at diabetes diagnosis
Tidsramme: Day 1
|
Age at diabetes diagnosis will be correlated with C-peptide level
|
Day 1
|
|
Duration of diabetes
Tidsramme: Day 1
|
Duration of diabetes will be correlated with C-peptide level
|
Day 1
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Robert Rapaport, MD, Icahn School of Medicine at Mount Sinai
- Ledende efterforsker: Evan Graber, DO, Icahn School of Medicine at Mount Sinai
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Wherrett DK, Bundy B, Becker DJ, DiMeglio LA, Gitelman SE, Goland R, Gottlieb PA, Greenbaum CJ, Herold KC, Marks JB, Monzavi R, Moran A, Orban T, Palmer JP, Raskin P, Rodriguez H, Schatz D, Wilson DM, Krischer JP, Skyler JS; Type 1 Diabetes TrialNet GAD Study Group. Antigen-based therapy with glutamic acid decarboxylase (GAD) vaccine in patients with recent-onset type 1 diabetes: a randomised double-blind trial. Lancet. 2011 Jul 23;378(9788):319-27. doi: 10.1016/S0140-6736(11)60895-7. Epub 2011 Jun 27.
- Sperling MA, Weinzimer SA, Tamborlane WV. Diabetes Mellitus. In: Sperling MA ed. Pediatric Endocrinology. 3rd ed. Philadelphia, PA: Saunders Elsevier; 2008:385
- Orban T, Bundy B, Becker DJ, DiMeglio LA, Gitelman SE, Goland R, Gottlieb PA, Greenbaum CJ, Marks JB, Monzavi R, Moran A, Raskin P, Rodriguez H, Russell WE, Schatz D, Wherrett D, Wilson DM, Krischer JP, Skyler JS; Type 1 Diabetes TrialNet Abatacept Study Group. Co-stimulation modulation with abatacept in patients with recent-onset type 1 diabetes: a randomised, double-blind, placebo-controlled trial. Lancet. 2011 Jul 30;378(9789):412-9. doi: 10.1016/S0140-6736(11)60886-6. Epub 2011 Jun 28.
- Pescovitz MD, Greenbaum CJ, Krause-Steinrauf H, Becker DJ, Gitelman SE, Goland R, Gottlieb PA, Marks JB, McGee PF, Moran AM, Raskin P, Rodriguez H, Schatz DA, Wherrett D, Wilson DM, Lachin JM, Skyler JS; Type 1 Diabetes TrialNet Anti-CD20 Study Group. Rituximab, B-lymphocyte depletion, and preservation of beta-cell function. N Engl J Med. 2009 Nov 26;361(22):2143-52. doi: 10.1056/NEJMoa0904452.
- Gottlieb PA, Quinlan S, Krause-Steinrauf H, Greenbaum CJ, Wilson DM, Rodriguez H, Schatz DA, Moran AM, Lachin JM, Skyler JS; Type 1 Diabetes TrialNet MMF/DZB Study Group. Failure to preserve beta-cell function with mycophenolate mofetil and daclizumab combined therapy in patients with new- onset type 1 diabetes. Diabetes Care. 2010 Apr;33(4):826-32. doi: 10.2337/dc09-1349. Epub 2010 Jan 12.
- Wang L, Lovejoy NF, Faustman DL. Persistence of prolonged C-peptide production in type 1 diabetes as measured with an ultrasensitive C-peptide assay. Diabetes Care. 2012 Mar;35(3):465-70. doi: 10.2337/dc11-1236.
- Keenan HA, Sun JK, Levine J, Doria A, Aiello LP, Eisenbarth G, Bonner-Weir S, King GL. Residual insulin production and pancreatic ss-cell turnover after 50 years of diabetes: Joslin Medalist Study. Diabetes. 2010 Nov;59(11):2846-53. doi: 10.2337/db10-0676. Epub 2010 Aug 10.
- Effects of age, duration and treatment of insulin-dependent diabetes mellitus on residual beta-cell function: observations during eligibility testing for the Diabetes Control and Complications Trial (DCCT). The DCCT Research Group. J Clin Endocrinol Metab. 1987 Jul;65(1):30-6. doi: 10.1210/jcem-65-1-30.
- Greenbaum CJ, Anderson AM, Dolan LM, Mayer-Davis EJ, Dabelea D, Imperatore G, Marcovina S, Pihoker C; SEARCH Study Group. Preservation of beta-cell function in autoantibody-positive youth with diabetes. Diabetes Care. 2009 Oct;32(10):1839-44. doi: 10.2337/dc08-2326. Epub 2009 Jul 8.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. oktober 2012
Primær færdiggørelse (Faktiske)
1. december 2013
Studieafslutning (Faktiske)
1. december 2013
Datoer for studieregistrering
Først indsendt
8. april 2014
Først indsendt, der opfyldte QC-kriterier
2. maj 2014
Først opslået (Skøn)
6. maj 2014
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
6. maj 2014
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
2. maj 2014
Sidst verificeret
1. maj 2014
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- GCO 12-1425
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Type 1 diabetes mellitus
-
Superior UniversityAktiv, ikke rekrutterendeType 2 Diabetes Mellitus 1Pakistan
-
Sultan Qaboos UniversityUniversity of Mosul; University of Child Health Sciences and Children's...Ikke rekrutterer endnuType 1 diabetes mellitus | T1DM | Type 1 diabetes mellitus (T1DM) | T1DM - Type 1 Diabetes Mellitus
-
University of Colorado, DenverMassachusetts General Hospital; Beta Bionics, Inc.AfsluttetDiabetes mellitus, type 1 | Type 1 diabetes | Diabetes type 1 | Type 1 diabetes mellitus | Autoimmun diabetes | Diabetes mellitus, insulinafhængig | Juvenil-Debut Diabetes | Diabetes, autoimmun | Insulinafhængig diabetes mellitus 1 | Diabetes mellitus, insulinafhængig, 1 | Diabetes mellitus, skør | Diabetes Mellitus... og andre forholdForenede Stater
-
University of California, San FranciscoJuvenile Diabetes Research FoundationAfsluttetType 1 diabetes mellitus | Diabetes mellitus, type I | Insulinafhængig diabetes mellitus 1 | Diabetes mellitus, insulinafhængig, 1 | IDDMForenede Stater, Australien
-
COUR Pharmaceutical Development Company, Inc.RekrutteringType 1 diabetes | Type 1 diabetes mellitus | T1DM | T1D | Type 1-diabetes i ungdomsårene | Type 1-diabetes hos børn | Type 1-diabetespatienter | Type 1 diabetes melitis | T1DM - Type 1 Diabetes Mellitus | Type 1-diabetes (juvenil debut)Forenede Stater
-
Capillary Biomedical, Inc.AfsluttetDiabetes mellitus, type 1 | Type 1 diabetes | Type 1 diabetes mellitus | Diabetes mellitus, insulinafhængig, 1Australien
-
Assiut UniversityIkke rekrutterer endnuDiBortes mellitus type 1
-
Liom Health AGDCB Research AGAfsluttetType 1 diabetes mellitus | Type 1 diabetes mellitus med hypoglykæmi | Type 1-diabetes mellitus med hyperglykæmiSchweiz
-
Medical College of WisconsinIkke rekrutterer endnuType 1 diabetes | Type 1 diabetes mellitus | type 1 diabetes | Ikke-næringsmæssigt sødemiddelForenede Stater
-
National Institute of Allergy and Infectious Diseases...PPD; Rho Federal Systems Division, Inc.; Immune Tolerance Network (ITN)AfsluttetType 1 diabetes mellitus | T1DM | T1D | Nyopstået type 1-diabetes mellitusForenede Stater, Australien
Kliniske forsøg med Boost shake
-
KU LeuvenJessa Hospital; University Hospital, Ghent; Vrije Universiteit Brussel; Revalidatieziekenhuis...Rekruttering
-
Erasmus Medical CenterUniversity Medical Center Groningen; Academisch Medisch Centrum - Universiteit... og andre samarbejdspartnereAktiv, ikke rekrutterendeCovid-19 vaccinationHolland
-
National Cancer Institute, EgyptUkendtBivirkning til strålebehandlingEgypten
-
University College, LondonNational Institute for Health Research, United KingdomUkendtTidlig brystkræftFrankrig, Korea, Republikken, Det Forenede Kongerige, Italien, Forenede Stater, Kina, Malaysia, Saudi Arabien, Sydafrika, Spanien, Schweiz, Thailand
-
Immunitor LLCUkendtGlioblastoma Multiforme | HjernegliomMongoliet
-
St George Hospital, AustraliaUkendt
-
University Hospitals, LeicesterNovartis; Medical Research Council; Public Health England; National Institute...AfsluttetInfluenzaDet Forenede Kongerige
-
Philips RespironicsAfsluttetSund og rask | Søvnmangel | Utilstrækkeligt søvnsyndromForenede Stater
-
City of Hope Medical CenterNational Cancer Institute (NCI)RekrutteringAnatomisk fase I brystkræft AJCC v8 | Anatomisk fase II brystkræft AJCC v8 | Anatomisk fase III brystkræft AJCC v8 | BrystkarcinomForenede Stater
-
University of AarhusAarhus University HospitalAfsluttet