Clinical Evaluation of Salivary 1,5-Anhydroglucitol in Diabetes
ConditionType 2 Diabetes (T2DM)
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorShanghai 6th People's Hospital
About this trial
The goal of this observational study is to evaluate the clinical value of salivary 1,5-anhydroglucitol (1,5-AG) and assess a novel noninvasive detection approach in individuals with and without type 2 diabetes. Additionally, the study will examine the relationships of salivary 1,5-AG with serum 1,5-AG and continuous glucose monitoring (CGM) measures of short-term glycemic control and fluctuations.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged between 18 and 80 years.
Individuals without a history of diabetes, or patients with type 2 diabetes mellitus.
Disqualifiers
History of systemic glucocorticoid treatment within the previous 6 weeks.
Presence of acute infection.
Presence of severe oral conditions that may affect saliva collection or measurement.
Presence of severe hepatic or renal dysfunction.
Trial population
The participants are enrolled from the Department of Endocrinology and Metabolism from Shanghai Sixth People's Hospital.
Trial design
Design model
Case-only
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Correlation Between Salivary 1,5-Anhydroglucitol and Glycemic Levels
Salivary 1,5-anhydroglucitol (1,5-AG) will be measured by liquid chromatography-mass spectrometry or enzymatic assay. Glycemic levels will be assessed by fasting plasma glucose (mmol/L), glycated hemoglobin A1c (HbA1c, %), and glycated albumin (GA, %). Pearson or Spearman correlation coefficients will be used to assess their correlations with salivary 1,5-AG.
Time frame
ScreeningSecondary outcomes
1
Correlation Between Salivary and Serum 1,5-Anhydroglucitol Levels
Salivary 1,5-AG will be measured by LC-MS or enzymatic assay, and serum 1,5-AG will be measured by enzymatic assay. Pearson or Spearman correlation coefficients will be calculated.
Time frame
Screening2
Correlation Between Salivary 1,5-Anhydroglucitol and Continuous Glucose Monitoring Metrics
Salivary 1,5-AG will be measured by LC-MS or enzymatic assay. CGM metrics will include time in range (TIR), time in tight range (TITR), and time above range (TAR), expressed as percentages.
Time frame
One weekSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: