Clinical Evaluation of Salivary 1,5-Anhydroglucitol in Diabetes

N/ANot Yet RecruitingNCT07781683

Shanghai 6th People's Hospital180 enrolled

Overview

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.

Serum 1,5-anhydroglucitol (1,5-AG) is a marker of short-term glycemic status and is particularly sensitive to recent hyperglycemic excursions. Saliva offers a noninvasive and convenient alternative for repeated metabolic monitoring, but the clinical application of salivary 1,5-AG has been limited by challenges in detection accuracy and standardization. This study therefore aims to evaluate the clinical value of salivary 1,5-AG and a novel noninvasive detection approach. First, the study will assess salivary 1,5-AG levels and compare the novel detection approach with reference measurements. Second, it will evaluate the relationships of salivary 1,5-AG with serum 1,5-AG and continuous glucose monitoring (CGM) metrics to determine its potential for reflecting short-term glycemic fluctuations and glycemic control.

Study Type

OBSERVATIONAL

Enrollment

180

Conditions

Type 2 Diabetes (T2DM)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Aged between 18 and 80 years. 2. Individuals without a history of diabetes, or patients with type 2 diabetes mellitus. Exclusion Criteria: 1. History of systemic glucocorticoid treatment within the previous 6 weeks. 2. Presence of acute infection. 3. Presence of severe oral conditions that may affect saliva collection or measurement. 4. Presence of severe hepatic or renal dysfunction. 5. History of alcohol abuse or psychiatric disorders, including depression. 6. Current treatment with sodium-glucose cotransporter 2 (SGLT2) inhibitors.

Locations (1)

Shanghai Sixth People's Hospital

Shanghai, Shanghai Municipality, China

Outcomes

Primary Outcomes

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: Screening

Secondary Outcomes

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: Screening

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 week

Central Contacts

Hang Su, MD

CONTACT

+86-021-64369181 suhang@shsmu.edu.cn

Data from ClinicalTrials.gov

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