Observational Analysis of the Associational Between Dietary Factors and Postprandial Glucose Fluctuations

Обзор

This study aims to observe the differences in postprandial blood glucose fluctuations in patients with type 2 diabetes and healthy individuals after consuming different dietary recipes through a prospective cohort study, in order to optimize individualized dietary strategies.

Первичные конечные точки

• postprandial glycemic response [Срок оценки: 14 days]

Вторичные конечные точки (1)

• postprandial blood glucose peak [Срок оценки: 14 days]

Критерии участия

Критерии включения

• For diabetes cohort:

• diagnosed with type 2 diabetes is more than one month
• Glycated hemoglobin (HbA1c) : 6.5%<HbA1c<10.5%(48 mmol/mol < HbA1c < 91.3 mmol/mol)
• Requirements for the blood glucose management plan: Within one month before the start of the trial, a simple lifestyle, and/or one or more oral hypoglycemic drugs (metformin, DPP-4 inhibitors, SGLT-2 inhibitors, TZD drugs, GLP-1 receptor agonists), and/or basal insulin treatment once a day were adopted, and the regimen was required to be maintained stably within 7 days before the start of the trial and during the trial.
• Take the test voluntarily and sign the informed consent form.
• For Non-diabetic cohort:

• Glycated hemoglobin (HbA1c) : HbA1c<5.7%
• Fasting blood glucose was between 3.9 and 5.6 mmol/L, and 2-hour postprandial blood glucose was less than 7.8mmol/L
• Take the test voluntarily and sign the informed consent form.

Критерии исключения

• Skin damage, scars, redness and swelling at the wearing site, or those with subcutaneous edema at the wearing site of an infected person, or those allergic to disinfectants, medical adhesive tapes or patches.
• Epilepsy or cognitive impairment, immunosuppressive disorders, and systemic neurological diseases.
• Required emergency or inpatient treatment due to severe hypoglycemia (blood glucose < 3.0mmol/L with consciousness disorder), diabetic ketoacidosis, or non-ketotic hyperosmolar syndrome in the past six months.
• Severe circulatory disorders.
• Long-term gastrointestinal diseases (such as celiac disease, gastroparesis, etc.), or eating disorders or having undergone bariatric surgery (such as gastric bypass surgery); Has a history of severe infection within the past month; History of malignant tumors (except skin cancer); Mental illnesses such as depression; Severe liver and kidney dysfunction (renal function: estimated eGFR<30mL/min or maintenance dialysis required;) Liver function: ALT and AST>3 times the upper limit of the normal value or active liver disease. History of severe cardiovascular disease (NYHA cardiac function classification III-IV or BNP >400 pg/mL).
• Technical or language barriers: Inability to use research applications or understand text; Unable to cooperate with the use of research equipment such as continuous blood glucose monitors and accelerometers.
• Drug use: Immunosuppressants, proton pump inhibitors, or steroid drugs have been used in the past 4 weeks or are planned to be used during the study period.
• BMI<16.5 kg/m².
• Magnetic resonance imaging (MRI) examination is planned or conducted within 16 days of product use.
• Pregnant and lactating women, and those planning to become pregnant during the study period.
• Those whom the researchers consider unsuitable to participate in this clinical study.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 1 центр

• Zhongshan Hospital Fudan University — Шанхай

Идентификаторы

NCT: NCT07117188 · 20250519040454800

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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