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NCT07288372Toborzás még nem indult

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)

Forrás: ClinicalTrials.gov · Utoljára frissítve: 2025. dec. 23.

Rövid összefoglaló (regiszter, angolul)

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).

Állapot (regiszter)
Toborzás még nem indult
Vizsgálattípus
Megfigyeléses
Résztvevők száma
225 (tervezett)
Első benyújtás
2025. dec. 4.
Kezdés
2025. dec. 18.
Elsődleges befejezés
2027. jan. 1.
Fő szponzor
Shanghai 6th People's Hospital
NCT-szám
NCT07288372

Mit vállalsz

  • Vizsgálat típusa: Megfigyeléses
  • Tervezett résztvevők: 225
  • 2025. dec. 18. és az elsődleges befejezés (2027. jan. 1.) között
  • Nincs megadott helyszín, ország nélkül
  • Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket

A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.

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Korábbi kezelés

  • Previously diagnosed with diabetes.

Más betegség

  • History of gastrointestinal surgery (e.g., gastrectomy) or chronic pancreatic disease.
  • Known allergy to soy (as the standardized meal may contain soy-based components).

Laborértékek

  • 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).

Egyéb

  • 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.

Kiket keres a vizsgálat

  • 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.

Életkor a regiszterben: 18 év – 70 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad

A teljes feltétellista: ClinicalTrials.gov

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