Type 2 DiabetesNCT07288372
The CGM-OGTT Glycemic Homeostasis Study
An observational study of Type 2 Diabetes and Glucose Metabolism Disorders, run by Shanghai 6th People's Hospital.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Type 2 Diabetes, Glucose Metabolism Disorders
- Type of treatment
- Pill or oral medicine
- How many people
- 225 participants
- Where
- No sites listed yet
- Study dates
- 18 Dec 2025to 10 Aug 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This monocentric, prospective, observational study will enroll 225 adult participants (aged 18-70 years) who are at high risk for diabetes or present with abnormal glucose metabolism, but have not been previously diagnosed with diabetes. Participants must meet specific eligibility criteria, including having diabetes-related symptoms, impaired fasting glucose, elevated HbA1c in the pre-diabetes range, or established risk factors (e.g., obesity, family history of diabetes, hypertension, or dyslipidemia). Key Exclusion Criteria include a prior diagnosis of diabetes, use of medications affecting glucose metabolism, significant organ dysfunction, or pregnancy. Upon enrollment, all participants will undergo a standardized 75g Oral Glucose Tolerance Test (OGTT). Based on the OGTT results, they will be retrospectively categorized into three natural groups for comparative analysis: Normal Glucose Tolerance (NGT), Pre-Diabetes (Pre-DM), and Newly Diagnosed Type 2 Diabetes (T2DM).
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: An Exploratory Investigation Into the Mechanism of Glycemic Homeostasis Regulation Under the Synergistic Conditions of Continuous Glucose Monitoring (CGM) and Oral Glucose Tolerance Test (OGTT)
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).
Read more
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).
Read the 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
- Medical subject headings
- Diabetes Mellitus, Type 2, Glucose Metabolism Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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). | |
| 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. | |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between MMTT-induced glucose AUC and OGTT plasma glucose values
To establish a quantitative relationship by assessing the correlation between the area under the curve (AUC) of postprandial glucose derived from Continuous Glucose Monitoring (CGM) after a standardized Mixed-Meal Tolerance Test (MMTT) and the plasma glucose values at all standard time points during the Oral Glucose Tolerance Test (OGTT).
Measured: MMTT: 0-3 hours post-meal (for AUC calculation). OGTT: 0, 30, 60, 120, and 180 minutes (for plasma glucose values).
Secondary outcomes (23)
Glycemic Variability (GV)
Coefficient of variation (CV) of glucose levels, calculated from Continuous Glucose Monitoring (CGM) data.
Measured: Entire CGM monitoring period (10-14 days)
Dietary Macronutrient Intake Composition
The daily intake proportion of macronutrients (carbohydrates, protein, and fat), expressed as a percentage of total caloric intake, assessed via a dietary logging application.
Measured: From enrollment until the completion of the in-clinic OGTT (approximately 10-14 days).
Caloric Intake per Meal
The average energy intake (in kilocalories) per meal, estimated using a dietary logging application.
Measured: From enrollment until the completion of the in-clinic OGTT (approximately 10-14 days).
Mean Amplitude of Glycemic Excursions (MAGE)
Mean Amplitude of Glycemic Excursions, calculated from CGM data to quantify major glucose swings.
Measured: Entire CGM monitoring period (10-14 days)
Complexity of Glucose Time Series
Complexity of glucose time series (e.g., using multiscale entropy or similar indices) derived from CGM data.
Measured: Entire CGM monitoring period (10-14 days)
Glucose AUC after MMTT
Area under the curve of glucose levels after each Mixed-Meal Tolerance Test (MMTT), measured by CGM.
Measured: 0-3 hours after each MMTT
Glucose Levels During OGTT
Plasma levels of glucose at OGTT time points
Measured: OGTT: 0, 30, 60, 120, 180 minutes
Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
Insulin resistance index calculated from fasting glucose and fasting insulin levels.
Measured: Baseline (OGTT 0-minute sample)
Incidence of Postprandial Hypotension during OGTT
Occurrence of postprandial hypotension, defined as a maximum decrease in systolic blood pressure ≥ 20 mmHg from baseline after the OGTT.
Measured: OGTT: 0, 30, 60, 120, 180 minutes
Maximum reduction in systolic blood pressure (SBP) during OGTT
The maximum decrease (Δ) in systolic blood pressure from the baseline (pre-glucose ingestion) value at any standard time point during the Oral Glucose Tolerance Test.
Measured: OGTT: 0, 30, 60, 120, 180 minutes
Completion Rate of Home-based MMTT
Proportion of participants who successfully complete both home-based MMTTs.
Measured: Through study completion (up to 14 days)
Adverse Events during OGTT /MMTT
Incidence of adverse events (e.g., nausea, vomiting, bloating) occurring during the OGTT/MMTT procedure.
Measured: During the OGTT/MMTT procedure (approximately 3 hours)
GLP-1 serum concentration during OGTT
Serum concentration of Glucagon-like peptide-1 (GLP-1) at each standard time point in response to the Oral Glucose Tolerance Test (OGTT).
Measured: OGTT: 0, 30, 60, 120, and 180 minutes
GIP serum concentration during OGTT
Serum concentration of Glucose-dependent insulinotropic polypeptide (GIP) at each standard time point in response to the Oral Glucose Tolerance Test (OGTT).
Measured: OGTT: 0, 30, 60, 120, and 180 minutes
Insulin serum concentration during OGTT
Plasma insulin concentration at each time point of the Oral Glucose Tolerance Test (OGTT).
Measured: OGTT: 0, 30, 60, 120, 180 minutes
C-peptide serum concentration during OGTT
Plasma C-peptide concentration at each time point of the Oral Glucose Tolerance Test (OGTT).
Measured: OGTT: 0, 30, 60, 120, 180 minutes
Total GLP-1 AUC during OGTT
Total area under the curve (AUC) for the Glucagon-like peptide-1 (GLP-1) serum concentration profile in response to the Oral Glucose Tolerance Test (OGTT).
Measured: OGTT: 0, 30, 60, 120, and 180 minutes
Total GIP AUC during OGTT
Total area under the curve (AUC) for the Glucose-dependent insulinotropic polypeptide (GIP) serum concentration profile in response to the Oral Glucose Tolerance Test (OGTT).
Measured: OGTT: 0, 30, 60, 120, and 180 minutes
Association between Incretin Secretion and Glycemic Complexity
An exploratory analysis using multiple linear regression to assess the influence of GLP-1 AUC and GIP AUC (during OGTT) on the complexity of the glycemic time series (e.g., CGI) during the OGTT period, adjusting for covariates such as age, sex, and BMI.
Measured: During the in-clinic OGTT （0 to 180 minutes）
Time to Peak Glucose after Each Meal
The time (in minutes) from the start of a meal to the maximum postprandial glucose concentration, as determined by CGM data. The average for breakfast, lunch, and dinner will be calculated.
Measured: Throughout the CGM monitoring period (10-14 days), following each main meal.
Maximum reduction in diastolic blood pressure (DBP) during OGTT
The maximum decrease (Δ) in diastolic blood pressure from the baseline (pre-glucose ingestion) value at any standard time point during the Oral Glucose Tolerance Test.
Measured: OGTT: 0, 30, 60, 120, and 180 minutes
Glycated hemoglobin (HbA1c) level
The concentration of glycated hemoglobin (HbA1c) in venous blood samples collected on the day of the Oral Glucose Tolerance Test (OGTT). HbA1c reflects the average blood glucose level over the preceding 2 to 3 months
Measured: OGTT day (single time point, e.g., at the fasting blood draw)
Glycated albumin (GA) level
The concentration of glycated albumin (GA) in venous blood samples collected on the day of the Oral Glucose Tolerance Test (OGTT). GA reflects the average blood glucose level over the preceding 2 to 3 weeks
Measured: OGTT day (single time point, e.g., at the fasting blood draw)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2025
- Study start18 Dec 2025 (estimated)
- Primary completion1 Jan 2027 (estimated)
- Study completion10 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 225 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai 6th People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jian Zhou, Shanghai 6th People's Hospital
- Investigators
- Jian Zhou, Study chair, Shanghai Sixth People's Hospital, Shanghai, Shanghai 200233
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07288372
- Sponsor's protocol ID
- 20251120
- Status last verified
- Dec 2025
- First submitted
- 4 Dec 2025
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The individual participant data (IPD) collected in this study are highly sensitive, containing detailed glycemic profiles, hormone levels, and personal health information. To protect participant confidentiality and privacy as strictly stipulated in the informed consent form and approved by the ethics committee, the IPD will not be made publicly available. The data will be de-identified and stored securely for analysis by the principal investigative team only. In the future, requests for access to anonymized data may be considered on a case-by-case basis for legitimate scientific collaboration, subject to a formal data sharing agreement and approval from the institutional ethics committee.
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Investigation Into the Mechanism of Glycemic Homeostasis Regulation Under the Synergistic Conditions of Continuous Glucose Monitoring (CGM) and Oral Glucose Tolerance Test (OGTT)
- ClinicalTrials.gov ID
- NCT07288372
- Acronym / sponsor ID
- 20251120
- 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
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 225 participants (estimated)
- Lead sponsor
- Shanghai 6th People's HospitalUniversity, hospital or other
- Study start
- 18 Dec 2025 (estimated)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 10 Aug 2027 (estimated)
- First posted
- 17 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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). |
| 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. |
| 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This monocentric, prospective, observational study will enroll 225 adult participants (aged 18-70 years) who are at high risk for diabetes or present with abnormal glucose metabolism, but have not been previously diagnosed with diabetes. Participants must meet specific eligibility criteria, including having diabetes-related symptoms, impaired fasting glucose, elevated HbA1c in the pre-diabetes range, or established risk factors (e.g., obesity, family history of diabetes, hypertension, or dyslipidemia). Key Exclusion Criteria include a prior diagnosis of diabetes, use of medications affecting glucose metabolism, significant organ dysfunction, or pregnancy. Upon enrollment, all participants will undergo a standardized 75g Oral Glucose Tolerance Test (OGTT). Based on the OGTT results, they will be retrospectively categorized into three natural groups for comparative analysis: Normal Glucose Tolerance (NGT), Pre-Diabetes (Pre-DM), and Newly Diagnosed Type 2 Diabetes (T2DM).
Key inclusion criteria (6 listed)
- 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:
Key exclusion criteria (7 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlation between MMTT-induced glucose AUC and OGTT plasma glucose values
Time frame: MMTT: 0-3 hours post-meal (for AUC calculation). OGTT: 0, 30, 60, 120, and 180 minutes (for plasma glucose values).
To establish a quantitative relationship by assessing the correlation between the area under the curve (AUC) of postprandial glucose derived from Continuous Glucose Monitoring (CGM) after a standardized Mixed-Meal Tolerance Test (MMTT) and the plasma glucose values at all standard time points during the Oral Glucose Tolerance Test (OGTT).
23 secondary outcomes
Glycemic Variability (GV)
Time frame: Entire CGM monitoring period (10-14 days)
Dietary Macronutrient Intake Composition
Time frame: From enrollment until the completion of the in-clinic OGTT (approximately 10-14 days).
Caloric Intake per Meal
Time frame: From enrollment until the completion of the in-clinic OGTT (approximately 10-14 days).
Mean Amplitude of Glycemic Excursions (MAGE)
Time frame: Entire CGM monitoring period (10-14 days)
Complexity of Glucose Time Series
Time frame: Entire CGM monitoring period (10-14 days)
Glucose AUC after MMTT
Time frame: 0-3 hours after each MMTT
Glucose Levels During OGTT
Time frame: OGTT: 0, 30, 60, 120, 180 minutes
Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
Time frame: Baseline (OGTT 0-minute sample)
Incidence of Postprandial Hypotension during OGTT
Time frame: OGTT: 0, 30, 60, 120, 180 minutes
Maximum reduction in systolic blood pressure (SBP) during OGTT
Time frame: OGTT: 0, 30, 60, 120, 180 minutes
Completion Rate of Home-based MMTT
Time frame: Through study completion (up to 14 days)
Adverse Events during OGTT /MMTT
Time frame: During the OGTT/MMTT procedure (approximately 3 hours)
GLP-1 serum concentration during OGTT
Time frame: OGTT: 0, 30, 60, 120, and 180 minutes
GIP serum concentration during OGTT
Time frame: OGTT: 0, 30, 60, 120, and 180 minutes
Insulin serum concentration during OGTT
Time frame: OGTT: 0, 30, 60, 120, 180 minutes
C-peptide serum concentration during OGTT
Time frame: OGTT: 0, 30, 60, 120, 180 minutes
Total GLP-1 AUC during OGTT
Time frame: OGTT: 0, 30, 60, 120, and 180 minutes
Total GIP AUC during OGTT
Time frame: OGTT: 0, 30, 60, 120, and 180 minutes
Association between Incretin Secretion and Glycemic Complexity
Time frame: During the in-clinic OGTT （0 to 180 minutes）
Time to Peak Glucose after Each Meal
Time frame: Throughout the CGM monitoring period (10-14 days), following each main meal.
Maximum reduction in diastolic blood pressure (DBP) during OGTT
Time frame: OGTT: 0, 30, 60, 120, and 180 minutes
Glycated hemoglobin (HbA1c) level
Time frame: OGTT day (single time point, e.g., at the fasting blood draw)
Glycated albumin (GA) level
Time frame: OGTT day (single time point, e.g., at the fasting blood draw)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
- Individual participant dataSharing planned: No. The individual participant data (IPD) collected in this study are highly sensitive, containing detailed glycemic profiles, hormone levels, and personal health information. To protect participant confidentiality and privacy as strictly stipulated in the informed consent form and approved by the ethics committee, the IPD will not be made publicly available. The data will be de-identified and stored securely for analysis by the principal investigative team only. In the future, requests for access to anonymized data may be considered on a case-by-case basis for legitimate scientific collaboration, subject to a formal data sharing agreement and approval from the institutional ethics committee.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jian Zhou study chair
Shanghai Sixth People's Hospital, Shanghai, Shanghai 200233
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes and Glucose Metabolism Disorders, run by Shanghai 6th People's Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jian Zhou, PhD (+86 021 24056515, zhoujian@sjtu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between MMTT-induced glucose AUC and OGTT plasma glucose values (time frame: MMTT: 0-3 hours post-meal (for AUC calculation). OGTT: 0, 30, 60, 120, and 180 minutes (for plasma glucose values).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2025.