The Ameliorative Role of Diabetes Remission in Aging: A Real-World-Based Prospective Clinical Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 主要终点
- Change in DunedinPACE epigenetic clock from baseline to 24 weeks.
研究概览
简要总结
This study is a real-world, prospective clinical cohort study. It will enroll Chinese patients with type 2 diabetes. The aim is to assess the changes in aging biomarkers, primarily DunedinPACE, from baseline to post-remission, and to compare these biomarkers between patients who achieve successful remission and those who do not.
详细描述
This prospective real-world cohort study will enroll 100 Chinese patients with type 2 diabetes, aged 35-70 years. All participants will receive a 24-week multimodal intervention comprising caloric restriction, dietary counseling, exercise training, and adjustment of glucose-lowering medications. DNA methylation levels will be assessed using the Illumina Epic array to calculate the epigenetic aging clock (DunedinPACE), enabling evaluation of changes in biological aging from baseline to 24 weeks, as well as comparisons between patients with and without successful remission. In addition, changes in inflammatory cytokines, metabolic parameters, body composition, and other aging-related biomarkers will be monitored. The findings are expected to provide novel evidence for the benefits of type 2 diabetes remission.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 35 to 70 years.
- •Diagnosis of type 2 diabetes mellitus according to WHO criteria, with disease duration ≤6 years.
- •HbA1c between 7.0% and 9.5%, OR currently on glucose-lowering medications.
- •Fasting C-peptide ≥1.0 ng/mL.
- •Fasting plasma glucose <13.3 mmol/L.
- •BMI between 25 and 45 kg/m².
- •Willing and able to provide informed consent and comply with study procedures
排除标准
- •Diabetes mellitus secondary to other causes (e.g., Cushing's syndrome, hypothyroidism, glucagonoma, drug-induced, or genetic factors).
- •BMI <25 kg/m² or >45 kg/m²; weight loss >5% within the last 3 months; actively trying to lose weight within the last 3 months; use of weight-loss agents, contraceptives, glucocorticoids, or any medication other than antidiabetic drugs that may affect study outcome measurements within the last 3 months; history of bariatric surgery.
- •Type 1 diabetes; type 2 diabetes duration >10 years; gestational diabetes; other specific types of diabetes.
- •Diagnosis of acute metabolic diabetic complications (e.g., diabetic ketoacidosis or hyperosmolar hyperglycemic state) or diabetes insipidus within 30 days, or history thereof.
- •Blood pressure ≥180/110 mmHg or malignant hypertension.
- •History of severe gastrointestinal disease; significant cardiac, hepatic, renal, or other systemic organ dysfunction (NYHA functional class ≥II; ALT and/or AST >4× upper limit of normal; GFR <60 mL/min); anemia or other hematological disorders; history of malignancy.
- •History of bariatric surgery or other gastrointestinal surgery causing chronic malabsorption within the past 2 years.
- •Use within 3 months prior to screening of any of the following:
- •i. GLP-1 receptor agonists, GLP-1R/GCGR agonists, GIPR/GLP-1R agonists, or GIPR/GLP-1R/GCGR agonists; ii. Medications affecting body weight, including systemic corticosteroids (intravenous, oral, or intra-articular), tricyclic antidepressants, psychiatric medications, or sedatives (e.g., imipramine, amitriptyline, mirtazapine, paroxetine, phenelzine, chlorpromazine, thioridazine, clozapine, olanzapine, valproic acid, valproate derivatives, lithium); iii. Chinese herbal medicines, dietary supplements, or meal replacements that affect body weight; iv. Previous or current use of anti-obesity drugs such as sibutramine, orlistat, phentermine, phenylpropanolamine, mazindol, diethylpropion, lorcaserin, phentermine/topiramate, naltrexone/bupropion; consumption of any alcoholic product within 48 hours prior to screening, or a positive alcohol screening test.
- •Drug abuse or alcohol dependence; severe psychiatric or neurological disorders.
- •Pregnant or breastfeeding women, or women planning to become pregnant within 1 year.
- •Special dietary requirements, or allergy to soy, dairy, or other foods.
- •Current participation in another clinical trial; unwillingness to comply with the lifestyle management and follow-up of this study; or judged by the investigator to be unsuitable for participation.
- •Unwilling or unable to provide informed consent.
结局指标
主要结局
Change in DunedinPACE epigenetic clock from baseline to 24 weeks.
时间窗: Baseline to 24 weeks
DunedinPACE is derived from Illumina Epic DNA methylation data. The change score is compared between participants with and without diabetes remission (remission defined as HbA1c \<6.5% off glucose-lowering drugs for ≥3 months).
次要结局
未报告次要终点