The CGM-OGTT Glycemic Homeostasis Study

NCT ID: NCT07288372

Last Updated: 2025-12-23

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 225 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-12-18
• Study Completion Date: 2027-08-10

Brief 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).

Detailed Description

Background and Rationale:

The oral glucose tolerance test (OGTT) is the gold standard for diagnosing diabetes but has limitations, including its inability to reflect daily glycemic variability and the discomfort caused by a high glucose load, which may not represent physiological conditions. Continuous glucose monitoring (CGM) captures comprehensive glycemic fluctuations in free-living settings. The mixed-meal tolerance test (MMTT), containing macronutrients like fat and protein, better simulates a physiological meal and may be better tolerated. However, the quantitative relationship between CGM-derived parameters from home-based MMTTs and the diagnostic outcomes of the standard OGTT remains unclear. Furthermore, the role of gastrointestinal hormone responses (e.g., GLP-1, GIP) during an OGTT in modulating subsequent daily glycemic homeostasis is an area of exploratory interest. This study aims to bridge these gaps by synergistically utilizing CGM, MMTT, and OGTT to investigate the mechanisms of glycemic regulation.

Study Design and Methodology:

This is a single-center, prospective, exploratory, observational study. Participants will wear a blinded CGM sensor for 10-14 days to prevent behavioral bias. The study comprises three sequential phases:

At-home MMTT Phase (Day 2 and another day prior to hospital visit): Participants will perform two standardized MMTTs (a standard formula and a high-protein formula) at home after an overnight fast. Adherence and any adverse events will be monitored remotely via a dedicated mini-program and daily communication.

In-hospital OGTT and Biomarker Assessment Phase (Day 10-14): Participants will undergo a standard 75g OGTT at the clinic. Venous blood samples will be collected at fasting, 30, 60, 120, and 180 minutes for measuring glucose, insulin, C-peptide, GLP-1, GIP, and blood pressure/heart rate.

Group Allocation:

This is an observational study with no interventional allocation. After completion, participants will be categorized into three groups based solely on their 2-hour plasma glucose (2hPG) value from the OGTT, following WHO criteria: Normal Glucose Tolerance (NGT, 2hPG <7.8 mmol/L), Pre-diabetes (Pre-DM, 7.8 ≤ 2hPG <11.1 mmol/L), and Type 2 Diabetes (T2DM, 2hPG ≥11.1 mmol/L). Comparative analyses will be conducted across these naturally formed groups.

Statistical Considerations:

The sample size of 225 was calculated using G*Power for an ANOVA model (effect size f=0.25, α=0.05, power=0.80), accounting for a 20% dropout rate. The primary analysis will use the Full Analysis Set (FAS). Statistical methods will include Spearman correlation to assess the relationship between MMTT-induced CGM parameters and OGTT glucose values, Analysis of Covariance (ANCOVA) to compare CGM metrics across the three glycemic groups (adjusting for covariates like age and BMI), and Receiver Operating Characteristic (ROC) curve analysis to evaluate the predictive power of CGM parameters for OGTT-based diagnosis.

Scientific Value:

This study is designed as a mechanism-exploratory investigation. It seeks to validate a novel, patient-centric approach (home-based MMTT with CGM) against the diagnostic gold standard (OGTT) and to provide deeper insights into the integrated physiology of glycemic homeostasis, including the role of incretin hormones and its potential link to vascular responses like postprandial hypotension.

Conditions

Type 2 Diabetes; Glucose Metabolism Disorders

Keywords

Continuous Glucose Monitoring; CGM; Oral Glucose Tolerance Test; OGTT; Mixed-Meal Tolerance Test; Glycemic Variability; Incretins; Home-Based Testing; GLP-1; GIP

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Normal Glucose Tolerance (NGT)

Participants with normal glucose tolerance as defined by a 2-hour plasma glucose value \< 7.8 mmol/L during the oral glucose tolerance test (OGTT).

No interventions assigned to this group

Pre-diabetes (Pre-DM)

Participants with pre-diabetes (intermediate hyperglycemia) as defined by a 2-hour plasma glucose value between 7.8 mmol/L and 11.0 mmol/L during the OGTT.

No interventions assigned to this group

Newly Diagnosed Type 2 Diabetes (T2DM)

Participants with newly diagnosed type 2 diabetes as defined by a 2-hour plasma glucose value ≥ 11.1 mmol/L during the OGTT.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

To be eligible to participate in this study, an individual must meet ALL of the following criteria:

• Is aged between 18 and 70 years, inclusive.
• And meets at least ONE of the following conditions:

• Presents with diabetes-related clinical symptoms or signs (e.g., unexplained ·polydipsia, polyphagia, polyuria, weight loss) and has been advised by a ·clinician to undergo an OGTT for diagnostic clarification.
• Has indicators of abnormal glucose metabolism:Impaired Fasting Glucose (IFG): Fasting venous plasma glucose ≥ 6.1 mmol/L and < 7.0 mmol/L.and/or Glycated hemoglobin (HbA1c) in the pre-diabetes range of 5.7% to 6.4%.
• Has at least one of the following diabetes risk factors:Body Mass Index (BMI) ≥ 24 kg/m²；Has a first-degree relative (parent, sibling, or child) with a history of diabetes；Has a history of hypertension (or undergoing antihypertensive treatment) or dyslipidemia.

Exclusion Criteria

• An individual who meets ANY of the following criteria will be excluded from participation in this study:
• Previously diagnosed with diabetes.
• Use of medications that significantly affect glucose metabolism or gastrointestinal hormones (e.g., GLP-1 receptor agonists, DPP-4 inhibitors, glucocorticoids) within a specified washout period prior to enrollment.
• History of gastrointestinal surgery (e.g., gastrectomy) or chronic pancreatic disease.
• Presence of severe hepatic or renal impairment (e.g., ALT > 3 times the upper limit of normal, or eGFR < 45 mL/min/1.73m²).
• Pregnant or lactating women, or women planning to become pregnant during the study period.
• Known allergy to soy (as the standardized meal may contain soy-based components).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai 6th People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jian Zhou

Principal Investigator, Professor, Chief Physician, Head of Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jian Zhou

Role: STUDY_CHAIR

Shanghai Sixth People's Hospital, Shanghai, Shanghai 200233

Central Contacts

Jian Zhou, PhD

Role: CONTACT

Phone: +86 021 24056515

Email: zhoujian@sjtu.edu.cn

Yue Zhang, Master's Degree

Role: CONTACT

Phone: +86 17851180860

Email: zyzy931@sjtu.edu.cn

Other Identifiers

20251120

Identifier Type: -

Identifier Source: org_study_id