NCT07288372Not yet recruiting
The CGM-OGTT Glycemic Homeostasis Study
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)
Source: ClinicalTrials.gov · Last updated 23 Dec 2025
Brief summary (registry, in English)
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).
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 225 (estimated)
- First submitted
- 4 Dec 2025
- Start date
- 18 Dec 2025
- Primary completion date
- 1 Jan 2027
- Lead sponsor
- Shanghai 6th People's Hospital
- Diseases
- Type 2 diabetes
- NCT number
- NCT07288372
What you commit to
- Study type: Observational
- Planned participants: 225
- From 18 Dec 2025 to the primary completion date, 1 Jan 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previously diagnosed with diabetes.
Other illness
- History of gastrointestinal surgery (e.g., gastrectomy) or chronic pancreatic disease.
- Known allergy to soy (as the standardized meal may contain soy-based components).
Lab values
- 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.
- Presence of severe hepatic or renal impairment (e.g., ALT \> 3 times the upper limit of normal, or eGFR \< 45 mL/min/1.73m²).
Other
- An individual who meets ANY of the following criteria will be excluded from participation in this study:
- Pregnant or lactating women, or women planning to become pregnant during the study period.
Who the study is looking for
- 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.
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.