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

NCT ID: NCT05370560

Last Updated: 2022-05-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 3325 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-12-01
• Study Completion Date: 2020-06-30

Brief Summary

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.

Conditions

Type 2 Diabetes; Impaired Glucose Regulation

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

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 concentration

Intervention Type: OTHER

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 concentration

Intervention Type: OTHER

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 concentration

Intervention Type: OTHER

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

Interventions

Plasma transthyretin concentration

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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 24 Years
• Maximum Eligible Age: 82 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Liegang Liu

OTHER

Sponsor Role: lead

Responsible Party

Liegang Liu

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Other Identifiers

YR202205

Identifier Type: -

Identifier Source: org_study_id