Clinical Evaluation of Salivary 1,5-Anhydroglucitol in Diabetes

NCT07781683 | Not Yet Recruiting DMC

• 1 other identifier: 20260820
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type 2 Diabetes (T2DM)

Outcome Measures

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.

  Screening

Secondary Outcomes (2)

• Correlation Between Salivary and Serum 1,5-Anhydroglucitol Levels

  Screening

• Correlation Between Salivary 1,5-Anhydroglucitol and Continuous Glucose Monitoring Metrics

  One week

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The participants are enrolled from the Department of Endocrinology and Metabolism from Shanghai Sixth People's Hospital.

You may qualify if:

• Aged between 18 and 80 years.
• Individuals without a history of diabetes, or patients with type 2 diabetes mellitus.

You may not qualify if:

• 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.
• History of alcohol abuse or psychiatric disorders, including depression.
• Current treatment with sodium-glucose cotransporter 2 (SGLT2) inhibitors.

Sponsors & Collaborators

• Shanghai 6th People's Hospital: lead

Study Sites (1)

Shanghai Sixth People's Hospital

Shanghai, Shanghai Municipality, 200233, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Hang Su, MD

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Chief Physician, Director

Study Record Dates

• First Submitted: August 20, 2026
• First Posted: August 24, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: August 25, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)