NCT07117188尚未招募不适用
Observational Analysis of the Associational Between Dietary Factors and Postprandial Glucose Fluctuations
Shanghai Zhongshan Hospital1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2025年8月5日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- postprandial glycemic response
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
postprandial glycemic response
时间窗: 14 days
postprandial glycemic response (PPGR) : PPGR refers to the dynamic changes in blood sugar levels after eating, reflecting the extent to which food affects blood sugar. PPGR is mainly determined by calculating the area under the Incremental curve (Incremental AUC, iAUC) of blood glucose.
次要结局
- postprandial blood glucose peak(14 days)
研究者
研究点 (1)
Loading locations...
相似试验
招募中
不适用
Glucose and Glycogen Dynamics in PrediabetesPre DiabetesNCT06317142Maastricht University Medical Center45
已完成
不适用
A Clinical Study to Investigate and Compare the Impact of High Protein Pasta, Lower Protein Pasta and White Rice on Blood Sugar Control in People With Type 1 Diabetes Mellitus (T1DM)Diabetes Mellitus, Type 1NCT03362151Sansum Diabetes Research Institute14
Unknown
不适用
Relationship Between Blood Glucose Variability and Prognosis in Critically Ill PatientsDiabetesNCT03629704Nanjing First Hospital, Nanjing Medical University200
尚未招募
不适用
Diabetes Self-management With Continuous Glucose MonitoringType 1 DiabetesNCT06453434Nordsjaellands Hospital500
已完成
不适用
Determination of the PPG and Insulin Responses of Rice Alone and Rice Consumed With Sugardown™Postprandial HyperglycemiaNCT03375398Boston Therapeutics10