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The CGM-OGTT Glycemic Homeostasis Study

NCT07288372 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 225

Last updated 2025-12-23

No results posted yet for this study

Summary

This is a prospective, exploratory, observational study aimed at investigating the mechanisms of glycemic homeostasis by comparing continuous glucose monitoring (CGM) data with results from the oral glucose tolerance test (OGTT).

The study plans to enroll approximately 225 participants aged 18-70 years who are at risk for or suspected of having glucose metabolism disorders, but without a prior diagnosis of diabetes. Participants will be equipped with a blinded CGM device for 10-14 days. During this period, they will perform two standardized mixed-meal tolerance tests (MMTT) at home. Subsequently, they will undergo a standard 75g OGTT at the hospital, where blood samples will be collected at multiple time points to measure glucose, insulin, C-peptide, and gastrointestinal hormones (GLP-1, GIP).

Based on the 2-hour blood glucose value from the OGTT, participants will be naturally categorized into three groups for comparative analysis: Normal Glucose Tolerance (NGT), Pre-diabetes (Pre-DM), and Newly Diagnosed Type 2 Diabetes (T2DM).

The primary objective is to establish a quantitative relationship between CGM-derived parameters (e.g., glycemic variability, time-in-range) after the MMTT and the OGTT diagnostic results. Secondary objectives include assessing the feasibility and correlation between home-based MMTT and standard OGTT, exploring the impact of gastrointestinal hormone responses on daily glucose fluctuations, and investigating the association between postprandial glucose dynamics and vascular reactivity (e.g., postprandial hypotension).

Conditions

Sponsors & Collaborators

  • Shanghai 6th People's Hospital

    lead OTHER

Principal Investigators

  • Jian Zhou · Shanghai Sixth People's Hospital, Shanghai, Shanghai 200233

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-18
Primary Completion
2027-01-01
Completion
2027-08-10

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07288372 on ClinicalTrials.gov