NCT07207980尚未招募不适用
Lifestyle Intervention Clinical Trial for the Remission of Type 2 Diabetes Mellitus in Primary Care (CREDOenAP)
Parc Sanitari Pere Virgili1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2026年1月11日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Presence of T2DM remission
研究概览
简要总结
The purpose of this clinical trial is to determine whether an intensive lifestyle intervention can achieve remission of type 2 diabetes mellitus (T2DM) in adult patients treated in primary care. The main questions the study seeks to answer are:
- What proportion of participants achieve diabetes remission after 6 months of intervention?
- How many participants maintain remission 12 months after completing the program (18 months total)?
Participants will:
- Follow a personalized dietary plan with carbohydrate restriction.
- Engage in moderate, accessible physical activity.
- Implement strategies to improve circadian rhythm regularity.
- Receive psychological counseling and support.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- 否
入选标准
- •Signed informed consent.
- •Men and women aged 18-80 years, inclusive.
- •Confirmed diagnosis of T2DM according to recognized diagnostic criteria
- •Most recent recorded hemoglobin A1c (HbA1c) > 6.5%.
- •Body Mass Index (BMI) greater than 27 kg/m².
排除标准
- •Failure to meet the diagnostic criteria for T2DM in the screening laboratory tests.
- •Being dependent for basic activities of daily living (Barthel score ≤ 90 points).
- •Lack of willingness to cooperate with the follow-up of the lifestyle intervention plan.
- •Presence of serious or terminal comorbidities significantly worsening short- to medium-term prognosis (active cancer, terminal chronic diseases, myocardial infarction within the last 6 months, acute heart failure or NYHA stage ≥ III, etc.).
- •History of ketoacidosis.
- •Presence of criteria or potential autoimmune insulinopenia (abnormal C-peptide, anti-GAD+ antibodies, pattern of basal and/or glucose-stimulated hypoinsulinemia).
- •Cognitive impairment.
- •Weight loss exceeding 5 kg in the past 6 months.
- •Significant changes in physical activity and/or dietary patterns in the past 6 months.
- •History of eating disorders.
- •History of substance abuse.
- •History of severe psychiatric disorders.
- •Pregnancy or intention to become pregnant within the study period.
结局指标
主要结局
Presence of T2DM remission
时间窗: After 6 months of intervention and 12 months after the intervention
Glycated hemoglobin (HbA1c): T2DM remission will be considered if HbA1c is \< 6.5% after 6 months of intervention and at least 3 months without antidiabetic medication. HbA1c will be determined by blood analysis after a minimum of 8 hours of fasting Fasting plasma glucose: T2DM remission will be considered if fasting venous plasma glucose is \< 126 mg/dL after 6 months of intervention and at least 3 months without antidiabetic medication. Fasting plasma glucose will be measured by venous blood analysis after a minimum of 8 hours of fasting
次要结局
- Total cholesterol(After 6 months of intervention and 12 months after the intervention)
- Blood pressure(After 6 months of intervention and 12 months after the intervention.)
- HDL cholesterol(After 6 months of intervention and 12 months after the intervention)
- Presence and size of atherosclerotic plaques in carotid arteries(After 6 months of intervention and 12 months after the intervention)
- LDL cholesterol(After 6 months of intervention and 12 months after the intervention)
- Apolipoprotein B100 (ApoB100)(After 6 months of intervention and 12 months after the intervention)
- Insulin resistance(After 6 months of intervention and 12 months after the intervention)
- Triglycerides(After 6 months of intervention and 12 months after the intervention)
- Weight(After 6 months of intervention and 12 months after the intervention)
- Body Mass Index (BMI)(After 6 months of intervention and 12 months after the intervention)
- Pancreatic activity(After 6 months of intervention and 12 months after the intervention)
- Fasting insulin(After 6 months of intervention and 12 months after the intervention)
- Abdominal circumference(After 6 months of intervention and 12 months after the intervention)
- Metabolic Syndrome Diagnosis(After 6 months of intervention and 12 months after the intervention)
- NAFLD Liver Fat Score(After 6 months of intervention and 12 months after the intervention)
- NAFLD Fibrosis Score(After 6 months of intervention and 12 months after the intervention)
- Physical activity(After 6 months of intervention and 12 months after the intervention)
- Alcohol consumption(After 6 months of intervention and 12 months after the intervention)
- Circadian habits(After 6 months of intervention and 12 months after the intervention)
- Nutritional and energy composition:(After 6 months of intervention and 12 months after the intervention)
- Smoking habits(After 6 months of intervention and 12 months after the intervention)
- Health status(After 6 months of intervention and 12 months after the intervention)
- Medication consumption(After 6 months of intervention and 12 months after the intervention)
- Number of hypoglycemia episodes(During each follow-up telephone visit throughout the intervention, after 6 months of intervention and 12 months after the intervention)
- Number of symptomatic hyperglycemia episodes(During each follow-up telephone visit throughout the intervention, after 6 months of intervention and 12 months after the intervention)
- Total number of healthcare visits(During each follow-up telephone visit throughout the intervention, after 6 months of intervention and 12 months after the intervention)
- Number of diabetes-related emergency episodes(During each follow-up telephone visit throughout the intervention, after 6 months of intervention and 12 months after the intervention)
研究者
研究点 (1)
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