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Phenotyping Individuals With Neo-diagnosed Type 2 Diabetes at Risk for All-cause Mortality

29. juni 2020 opdateret af: Anna Solini, University of Pisa

Determining All Cause Morality and Cardiovascular Mortality Risk in Individuals With Neo-diagnosed Type 2 Diabetes

Prevalence of type 2 diabetes (T2D) is increasing worldwide over the last two decades; in these patients the rate of all-cause and cardiovascular (CV) mortality is several folds higher than in the general population, configuring a major public health problem. The clinical phenotype is the main determinant of such high mortality risk; however, a relevant role is played by the disease duration, with a significant interaction with metabolic control. However, for T2D the diagnosis does not correspond to the true onset of the disease, and a high lethality rate also in patients with recent onset of the disease cannot be excluded. Robust evidence supports this hypothesis, showing as in subjects with new-onset T2D, the mortality risk is superimposable, and even higher, than that observed in people with overt and long-term T2D. In this complex scenario, it would be desirable an early identification of high-risk patients, in which an accurate estimation of risk of complications, coupled with appropriate and timely interventions, might help in reducing the risk of encountering premature mortality. The present study was design to address this specific issue.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Patients referring for the first time to the outpatient diabetes clinic in the department of Internal Medicine between January 2008 and December 2015 and matching the inclusion criteria were recruited.

Diagnosis was confirmed on the basis of the Oral Glucose Tolerance Test (OGTT) or HbA1c ≥6.5% plus fasting blood glucose ≥126 mg/dl.

Anthropometric measurements were recorded, arterial pressure and vital parameters were registered, and blood samples were collected for routine analyses. Complete blood count, glucose, HbA1c, Serum Glutamic Oxaloacetic Transaminase (sGOT), Serum Glutamic Pyruvic Transaminase (sGPT), uric acid, were determined by standard techniques. Total and HDL cholesterol and triglycerides were assayed through the automated spectrophotometer, enzymatic colorimetric method, COBAS INTEGRA using commercial kits (Roche Diagnostics). Serum creatinine was measured by Jaffe' method, and estimated glomerular filtration rate (eGFR) was calculated according to the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula.

Previous major acute CV events, including myocardial infarction, stroke, foot ulcer/gangrene/amputation and coronary, carotid and lower limb revascularisation, were adjudicated based on hospital discharge records.

At the end of the baseline visit, patients were treated according to the good clinical practice recommended by the international guidelines, and followed a six-month or an yearly calendar of follow-up visits, until death or until 31 December 2018. All-cause mortality was assessed by checking the vital status of study participants on 31 December 2018; to this aim, investigators interrogated the Italian Health Card database, which provides updated information on all current Italian residents.

Incident major acute cardiovascular events were registered on the basis of clinical records every year; retinopathy onset was assessed by fundoscopy on a yearly basis.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

300

Kontakter og lokationer

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Studiesteder

  • Italien
      • Pisa, Italien, 56125
        • University of Pisa

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

30 år til 85 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Patients referring for the first time to the outpatient diabetes clinic in the department of Internal Medicine between January 2008 and December 2015 and matching the inclusion criteria.

Beskrivelse

Inclusion Criteria:

  • age ≥30 years
  • personal history of known T2D lasting not more than six months
  • diagnosis confirmed on the basis of the OGTT or HbA1c ≥6.5% plus fasting blood glucose ≥126 mg/dl

Exclusion Criteria:

  • longstanding disease duration
  • type 1 diabetes
  • diabetes secondary to steroid therapy
  • active cancer

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: Kohorte
  • Tidsperspektiver: Fremadrettet

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Patients with neo-diagnosed type 2 diabetes
Patients referring for the first time to the outpatient diabetes clinic in the department of Internal Medicine between January 2008 and December 2015 and matching the inclusion criteria.
Andet: standard treatments
patients were treated according to the good clinical practice recommended by the international guidelines, and followed a six-month or an yearly calendar of follow-up visits

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of participants who died during the study
Tidsramme: At 31 December 2018
The number of participants who died during the study was assessed by checking the vital status of study participants on 31 December 2018; to this aim, we interrogated the Italian Health Card database, which provides updated information on all current Italian residents.
At 31 December 2018
Incidence of cardiovascular disease
Tidsramme: At 31 December 2018
Incident major acute cardiovascular events were registered on the basis of clinical records every year
At 31 December 2018
Incidence of microvascular complication
Tidsramme: At 31 December 2018
Retinopathy onset was assessed by fundoscopy on a yearly basis.
At 31 December 2018

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change of renal function through study completion (an average of 5 year)
Tidsramme: From baseline until the end of observation or the date of death from any cause, whichever came first, assessed up to 60 months.
Serum creatinine was measured by Jaffe' method and expressed by mg/dl. It was used to calculate eGFR according to the CKD-EPI formula.
From baseline until the end of observation or the date of death from any cause, whichever came first, assessed up to 60 months.
Change of blood glucose through study completion (an average of 5 year)
Tidsramme: From baseline until the end of observation or the date of death from any cause, whichever came first, assessed up to 60 months.
Blood glucose was expressed in mg/dl and was determined by standard techniques.
From baseline until the end of observation or the date of death from any cause, whichever came first, assessed up to 60 months.
Change of HbA1c through study completion (an average of 5 year)
Tidsramme: From baseline until the end of observation or the date of death from any cause, whichever came first, assessed up to 60 months.
HbA1c was expressed as percentage or mmol/l and was determined by standard techniques.
From baseline until the end of observation or the date of death from any cause, whichever came first, assessed up to 60 months.

Samarbejdspartnere og efterforskere

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Sponsor

University of Pisa

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

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 (Faktiske)

1. januar 2008

Primær færdiggørelse (Faktiske)

31. december 2015

Studieafslutning (Faktiske)

31. december 2018

Datoer for studieregistrering

Først indsendt

7. maj 2020

Først indsendt, der opfyldte QC-kriterier

29. juni 2020

Først opslået (Faktiske)

1. juli 2020

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

1. juli 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. juni 2020

Sidst verificeret

1. juni 2020

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • AS0006

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