Pre-diabetes mellitus, diabetes mellitus
Conditions
Interventions
Pre-DM Group:Study candidates who are qualified will receive the vaccination of the 4th dose of BioNTech, attend 3 online questionnaires, 1 baseline assessment visit, and provide 2 sets of blood (both
DM Group:Study candidates who are qualified will receive the vaccination of the 4th dose of BioNTech, attend 3 online questionnaires, 1 baseline assessment visit, and provide 2 sets of blood (both mal
Healthy Control:Study candidates who are qualified will receive the vaccination of the 4th dose of BioNTech, attend 3 online questionnaires, 1 baseline assessment visit, and provide 2 sets of blood (b
Sponsors
School of Chinese Medicine, Hong Kong Baptist University
Eligibility
Sex/Gender
Male
Age
30 Years to 65 Years
Inclusion criteria
Inclusion criteria: - Aged 30-65 years. - Negative results by either PCR test or rapid antigen test 1 day prior to; and at the commencement of the study. - Have received 3 doses of BioNTech vaccines only prior to commencement of the study. - Individuals who intend to receive the 4th dose of BioNTech vaccine. - Either: 1) Healthy controls without known COVID infection history 2) Pre-diabetes mellitus patients without known COVID infection history 3) Diabetes mellitus patients without known COVID infection history - Fully understand what is involved in this study and give documented consent to participate in the study. - Able to understand and be able to follow written and oral instructions in Chinese.
Exclusion criteria
Exclusion criteria: - Individuals with any serious commodities, such as cardio-/cerebro-vascular, respiratory, digestive, hepatic, renal, haematological disease(s) or abnormalities of other organs and systems; malignancies, major infectious disease(s) or neuropsychiatric disorders. - Pregnant and nursing women as well as those who are suspected of being pregnant. - Vulnerable adults (i.e. mentally or physically disabled who cannot take care of himself/herself). - Individuals who have received non-BioNTech vaccines. - Individuals who have received the 4th dose of vaccine. - Individuals with known COVID infection history. - Others whom the investigator or co-investigator considered to be inappropriate for enrolment (justifiable reason(s) must be provided).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HOMA-IR index (including fasting plasma insulin and fasting plasma glucose level); | — |
Secondary
| Measure | Time frame |
|---|---|
| TyG index (including fasting triglyceride and fasting plasma glucose level);HOMA-beta index (fasting plasma glucose and insulin level);Glycated haemoglobin (HbA1c);Fasting high-density lipoprotein (HDL);Fasting low-density lipoprotein (LDL);Fasting cholesterol (TC);Body mass index;Incidences of adverse events following immunisation; | — |
Countries
China
Contacts
Public ContactZhaoxiang Bian
School of Chinese Medicine, Hong Kong Baptist University
Outcome results
None listed