Healthy and patients with type 2 diabetes mellitus in various severity Type 2 diabetes mellitus
Conditions
Interventions
Age-match with group B healthy control participants and 1)
within-normal level of FPG (less than 100 mg/dl) and HbA1C (less than 5.7%)
Healthy control is defined as a non-diabetic subject. Other medi
Healthy control,Level 1 Prediabetes condition,Level 2 T2DM without microvascular complication,Level 3 T2DM with microvascular complications
Sponsors
Office of the National Economic and Social Development Council
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Participants aged at least 18 years old (inclusive). 2. Age-match healthy volunteers (control) or participants diagnosed with type 2 diabetes mellitus in various severity (case) as detailed in the target population. 3. Must give informed consent before enrolment and study procedures. 4. Must comply with study procedures and be available for all study visits. 5. Must be in general good health based on medical history determined by the investigator(s) at screening. 6. History of medication, FPG, and HbA1C results as inclusion criteria. The results will be performed within 90 days prior to enrolment. 7. Adequate organ function as defined by the following criteria - ANC more than 1.5x109/L - Platelet count more than 100x109/L - Haemoglobin more than 9 g/dL without growth factor or blood component replacement - Serum AST and ALT less than 3 x upper limit of normal (ULN) - Serum bilirubin less than 1.5 x upper limit of normal (ULN)
Exclusion criteria
Exclusion criteria: 1. Presence of self-reported or medically documented significant medical or psychiatric condition(s) as judged by the investigator(s) that it may not be in the participants interest to participate in the study. 2. Presence of an acute illness, as determined by the PI(s), with or without fever (forehead temperature measured with validated device more than or equal to 37.5 Celsius) at screening or enrolment. 3. Current participation in any other interventional clinical trial or previously enrolled in an interventional clinical trial, which, in the opinion of the PI(s), may interfere with the interpretation of the trial results 4. History of recent antibiotic treatment within 30 days prior to enrolment. 5. Close affiliation with the PI(s), person(s) working at the trial site(s), or an employee of the sponsor (for example, a close relative). 6. Presence of a history of any invasive cancer except in situ cervical cancer, non melanoma, or remission of a minimum of 5 years from the date of randomization. 7. Presence of cardiovascular or stroke event.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Genetic of patients with type 2 diabetes mellitus risk 7 days SNP analysis | — |
Secondary
| Measure | Time frame |
|---|---|
| Stool microbiome of patients with type 2 diabetes mellitus risk 7 days SNP analysis,Exhale metabolite profiling of patients with type 2 diabetes mellitus risk 7 days Biomarker identification | — |
Countries
Thailand
Contacts
Public ContactThipaporn Tharavanij
Endocrinology and Metabolism Division, Department of Medicine, Faculty of Medicine, Thammasat University
Outcome results
None listed