NCT07288372
The CGM-OGTT Glycemic Homeostasis Study
Not Yet Recruiting · Not specified · Shanghai 6th People's Hospital · registry updated 2025-12-23
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
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)....
Inclusion
- 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
- 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.