The Impact of Diabetes Remission on Aging
The Ameliorative Role of Diabetes Remission in Aging: A Real-World-Based Prospective Clinical Cohort Study
研究概览
详细说明
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Pengfei Shan
- 电话号码:86-0571-87783777
- 邮箱:pengfeishan@zju.edu.cn
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:Comprehensive Lifestyle Intervention
|
Participants will receive a 24-week comprehensive lifestyle intervention:
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in DunedinPACE epigenetic clock from baseline to 24 weeks.
大体时间: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).
|
Baseline to 24 weeks
|
合作者和调查者
调查人员
- 首席研究员:Pengfei Shan、Second Affiliated Hospital, School of Medicine, Zhejiang University
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- 2026-0812
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
药物和器械信息、研究文件
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