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Completed

NCT Number: NCT05370560

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

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.

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Plasma transthyretin concentration

Other

Plasma transthyretin concentrations were measured by BS 200 Autoanalyser (Mindray, Shenzhen, China) using immunoturbidimetric method.

Primary outcomes

  1. Type 2 diabetes mellitus

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Liegang Liu

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2016
Study completion
2020
First posted
May 11, 2022
Registry last updated
May 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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