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Plasma Transthyretin Levels and Risk of Type 2 Diabetes Mellitus and Impaired Glucose Regulation

7. maj 2022 opdateret af: Liegang Liu

Plasma Transthyretin Levels and Risk of Type 2 Diabetes Mellitus and Impaired Glucose Regulation in a Chinese Population

Objective: To investigate the association between plasma transthyretin levels and risk of newly diagnosed type 2 diabetes mellitus (T2DM) and impaired glucose regulation (IGR) in a Chinese population.

Design: We performed a case-control study, including 1,244 newly diagnosed T2DM patients, 837 newly diagnosed IGR patients, and 1,244 individuals with normal glucose tolerance (NGT). The diagnostic criteria were recommended by World Health Organization in 1999. All cases were recruited from patients who, for the first time, received a diagnosis of T2DM in the Department of Endocrinology, Tongji Hospital, Tongji Medical College, Wuhan, China, from December 2010 to December 2016. Concomitantly, general population undergoing a routine health checkup in the same hospital were enrolled as controls. The inclusion criteria were age ≥ 30 years, BMI < 40 kg/m2, and no history of diagnosis of diabetes or receiving pharmacological treatment for hypertension and hyperlipidemia. Participants with clinically significant neurological, endocrinological, psychological or other systemic diseases, as well as acute illness or chronic inflammatory or infectious diseases, were excluded from the present study. Written informed consent was obtained from each participant. Besides, cases were stringently matched to controls in a 1:1 ratio, based on sex and age (± 3 years). All participants enrolled were of Han ethnicity, and gave a commitment of taking no medication known affecting glucose tolerance or insulin secretion before participating in the study. Fasting blood samples were collected in EDTA-anticoagulative tubes and separated for plasma within 1 h. Then plasma was kept at -80℃ prior to analyses. Plasma transthyretin levels were measured by BS 200 Autoanalyser (Mindray, Shenzhen, China) using immunoturbidimetric method.

Studieoversigt

Status

Afsluttet

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

3325

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

24 år til 82 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

All the participants enrolled were of Chinese Han ethnicity. They gave informed written consent to the study and did not take any medication known to affect glucose tolerance or insulin secretion before participation.

Beskrivelse

Inclusion Criteria:

  • Age ≥ 30 years, BMI < 40 kg/m2, and no history of diagnosis of diabetes or receiving pharmacological treatment for hypertension and hyperlipidemia

Exclusion Criteria:

  • Clinically significant neurological, endocrinological, psychological or other systemic diseases, as well as acute illness or chronic inflammatory or infectious diseases.

Incomplete basic information.

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
Type 2 diabetes mellitus
In this case-control study, T2DM was diagnosed according to the diagnostic criteria recommended by the WHO in 1999. T2DM was confirmed when fasting plasma glucose (FPG) ≥ 7.0 mmol/L and/or 2-h post-glucose load (OGTT2h) ≥ 11.1 mmol/L.
Plasma transthyretin concentrations were measured by BS 200 Autoanalyser (Mindray, Shenzhen, China) using immunoturbidimetric method.
Impaired glucose regulation
In this case-control study, IGR was diagnosed according to the diagnostic criteria recommended by the WHO in 1999. IGR was defined as impaired fasting glucose ([FPG] ≥ 6.1 mmol/L and < 7.0 mmol/L, and [OGTT2h] < 7.8 mmol/L) and/or impaired glucose tolerance (FPG < 7.0 mmol/L, and OGTT2h ≥ 7.8 mmol/L and < 11.1 mmol/L).
Plasma transthyretin concentrations were measured by BS 200 Autoanalyser (Mindray, Shenzhen, China) using immunoturbidimetric method.
Control
Those with FPG < 6.1 mmol/L and OGTT2h < 7.8 mmol/L were considered controls.
Plasma transthyretin concentrations were measured by BS 200 Autoanalyser (Mindray, Shenzhen, China) using immunoturbidimetric method.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Type 2 diabetes mellitus
Tidsramme: From December 2010 to December 2016
In the case-control study, type 2 diabetes mellitus was diagnosed in accordance with the diagnostic criteria recommended by WHO in 1999.
From December 2010 to December 2016

Samarbejdspartnere og efterforskere

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Sponsor

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. december 2010

Primær færdiggørelse (Faktiske)

31. december 2016

Studieafslutning (Faktiske)

30. juni 2020

Datoer for studieregistrering

Først indsendt

7. maj 2022

Først indsendt, der opfyldte QC-kriterier

7. maj 2022

Først opslået (Faktiske)

11. maj 2022

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

11. maj 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

7. maj 2022

Sidst verificeret

1. maj 2022

Mere information

Begreber relateret til denne undersøgelse

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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Kliniske forsøg med Type 2 diabetes

Kliniske forsøg med Plasma transthyretin concentration

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