Effectiveness of a Low-Calorie Diet Combined With Intensive Lifestyle Intervention Using Integrated Personalized Diabetes Management for Achieving Diabetes Remission in Patients With Type 2 Diabetes Mellitus: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Proportion of participants achieving diabetes remission based on HbA1c <6.5% without glucose-lowering medication at 3 months
研究概览
简要总结
The goal of this clinical trial is to determine whether a low-calorie diet combined with intensive lifestyle intervention using Integrated Personalized Diabetes Management (iPDM) is more effective than standard care in achieving diabetes remission in adults with overweight and type 2 diabetes mellitus. The study will also evaluate the effects of the intervention on metabolic and clinical outcomes associated with diabetes remission.
The main questions it aims to answer are:
- Does a low-calorie diet combined with intensive lifestyle intervention using iPDM increase the proportion of participants who achieve diabetes remission compared with standard care?
- Does the intervention improve metabolic and patient-centered outcomes, including glycemic control, body weight, body composition, Time in Range (TIR) measured by continuous glucose monitoring (CGM), quality of life, and cost-effectiveness?
Researchers will compare participants receiving a low-calorie diet combined with intensive lifestyle intervention using iPDM with participants receiving standard diabetes care to determine whether the intervention is more effective in achieving diabetes remission and improving metabolic health.
Participants will:
- Be randomly assigned to either the intervention group or the standard care group.
- Attend study visits for assessments of diabetes-related clinical and metabolic outcomes throughout the 6-month study.
- If assigned to the intervention group, consume two low-calorie meal replacements per day and follow an individualized meal plan providing no more than 1,200 kcal per day during the first 3 months (intensive phase), together with a personalized exercise program, continuous glucose monitoring (CGM), and lifestyle counseling delivered via telemedicine every 2 weeks. During the following 3 months (maintenance phase), continue lifestyle modification with reinforcement sessions delivered via telemedicine every 4 weeks while following a meal plan providing no more than 1,500 kcal per day.
详细描述
Participants will be randomized into two groups using block of four Group A: Intervention Group B: Standard care
Intervention group Phase 1: Intensive phase (Months 0-3) Month 0: Baseline assessment
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Data collection
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Demographics: sex, age, address, duration of diabetes, diabetes-related complications, comorbidities, current medications, drug/food allergies
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Physical examination: body weight, height, waist circumference, blood pressure, pulse rate
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Body composition analysis using bioelectrical impedance analysis (BIA)
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Fasting plasma glucose (FPG)
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Glycated hemoglobin (HbA1c)
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Fasting insulin
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Lipid profile
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Serum creatinine and electrolytes
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Liver function tests
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Urinalysis and spot urine albumin-to-creatinine ratio (UACR)
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Quality of life questionnaires: SF-36 and EQ-5D-5L
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Self-management questionnaire: Patient Activation Measure 13 (PAM-13)
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Mental health questionnaire: PHQ-2; if PHQ-2 ≥1, proceed with PHQ-9
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Education and support Structured diabetes remission education will be provided by certified diabetes educators, including physicians, nurses, dietitians, and exercise physiologists.
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Continuous Glucose Monitoring (CGM) Participants will wear a real-time CGM device (LinX CGM) for 15 days. Physicians will review the data via the LinX application every two weeks through telehealth consultations.
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Dietary intervention Participants will be provided with two low-calorie meals per day (400 kcal/meal; carb:protein:fat = 45:30:25) on Monday-Friday
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Nutrition education Participants will learn to calculate daily caloric intake (target ≤1,200 kcal/day) and record food intake on Saturdays and Sundays. Dietitians will review logs via telehealth every 2 weeks.
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Exercise program Participants will perform a 2-minute walk test and receive a personalized exercise plan. Exercise logs will be reviewed biweekly via telehealth with exercise physiologists.
Month 1
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with type 2 diabetes mellitus with HbA1c level of 6.0 to 9.0%. Participants with HbA1c of 6.0 to 6.4% were required to be receiving oral glucose lowering medication.
- •Diagnosed with type 2 diabetes mellitus for less than 6 years.
- •Body mass index of 23 kg/m2 or greater.
排除标准
- •Receiving more than two oral glucose-lowering medications.
- •Receiving insulin therapy.
- •Use of a glucagon-like peptide-1 receptor agonist (GLP-1 RA) within 3 months before study enrollment.
- •Use of medications known to affect HbA1c within 3 months before study enrollment, including corticosteroids, vitamin C (excluding vitamin C obtained from natural dietary sources or fruits), vitamin E, trimethoprim-sulfamethoxazole, or hydroxyurea.
- •History of diabetic ketoacidosis or hyperglycemic hyperosmolar state within the previous 6 months.
- •Unstable psychiatric disorders within the previous 2 years, including major depressive disorder, bipolar disorder, or schizophrenia.
- •Pregnant or breastfeeding women, or women planning to become pregnant within 12 months.
- •Presence of any of the following medical conditions based on medical history and clinical records, including chronic kidney disease with an estimated glomerular filtration rate less than 45 mL/min/1.73 m2, liver cirrhosis or hepatitis with alanine aminotransferase or aspartate aminotransferase more than 3 times the upper limit of normal, chronic alcohol abuse, hypothyroidism with thyroid-stimulating hormone more than 10 uIU/mL, HIV infection, anemia (hemoglobin less than 10 g/dL), iron deficiency, vitamin B12 deficiency, folate deficiency, thalassemia, glucose-6-phosphate dehydrogenase deficiency, hemolytic anemia, or hemoglobin more than 16 g/dL, heart failure or ischemic heart disease within the previous 6 months.
- •History of blood donation or blood transfusion within the previous 3 months.
- •Uncontrolled diabetic retinopathy or other uncontrolled retinal disease, including maculopathy, based on medical records.
- •Signs, symptoms, or a history of malignancy within 5 years before screening, except for basal cell carcinoma, squamous cell carcinoma of the skin, or other carcinoma in situ.
- •Major surgery within 90 days before enrollment or planned major surgery within 6 months after enrollment.
- •No access to a smartphone capable of supporting the study application and internet-based data transmission.
- •Unable to maintain communication with the study investigators according to the study protocol.
研究组 & 干预措施
Standard care
Standard diabetes care with routine clinical visits every 3 months.
干预措施: Standard Care (in control arm) (Other)
Low-calorie diet with intensive lifestyle intervention using iPDM
A low-calorie diet consisting of two meal replacements per day, with total daily energy intake restricted to no more than 1,200 kcal/day, will be provided together with a personalized exercise program, continuous glucose monitoring (CGM), and lifestyle counseling delivered via telemedicine every 2 weeks throughout the initial 3-month intensive phase. This will be followed by behavioral modification reinforcement and nutritional education delivered via telemedicine every 4 weeks during the subsequent 3-month maintenance phase, with a recommended total daily energy intake of no more than 1,500 kcal/day.
干预措施: Low-calorie diet (Behavioral)
Low-calorie diet with intensive lifestyle intervention using iPDM
A low-calorie diet consisting of two meal replacements per day, with total daily energy intake restricted to no more than 1,200 kcal/day, will be provided together with a personalized exercise program, continuous glucose monitoring (CGM), and lifestyle counseling delivered via telemedicine every 2 weeks throughout the initial 3-month intensive phase. This will be followed by behavioral modification reinforcement and nutritional education delivered via telemedicine every 4 weeks during the subsequent 3-month maintenance phase, with a recommended total daily energy intake of no more than 1,500 kcal/day.
干预措施: Continous Glucose Monitor (CGM) (Device)
Low-calorie diet with intensive lifestyle intervention using iPDM
A low-calorie diet consisting of two meal replacements per day, with total daily energy intake restricted to no more than 1,200 kcal/day, will be provided together with a personalized exercise program, continuous glucose monitoring (CGM), and lifestyle counseling delivered via telemedicine every 2 weeks throughout the initial 3-month intensive phase. This will be followed by behavioral modification reinforcement and nutritional education delivered via telemedicine every 4 weeks during the subsequent 3-month maintenance phase, with a recommended total daily energy intake of no more than 1,500 kcal/day.
干预措施: Personalized exercise program (Behavioral)
结局指标
主要结局
Proportion of participants achieving diabetes remission based on HbA1c <6.5% without glucose-lowering medication at 3 months
时间窗: 3 months
To evaluate the effectiveness of a low-calorie diet combined with intensive lifestyle intervention using Integrated Personalized Diabetes Management (iPDM), compared with standard diabetes care, in achieving diabetes remission at 3 months in adults with type 2 diabetes mellitus. Diabetes remission is defined as an HbA1c level \<6.5% at least 3 months in the absence of usual glucose-lowering pharmacotherapy.
次要结局
- Proportion of participants achieving diabetes remission based on HbA1c <6.5% without glucose-lowering medication at ุ6 months(6 months)
- Change in HbA1c from baseline to 3 and 6 months(3 and 6 months)
- Change in body mass index (BMI) from baseline to 3 and 6 months(3 and 6 months)
- Change in waist circumference from baseline to 3 and 6 months(3 and 6 months)
- Change in fat mass from baseline to 3 and 6 months(3 and 6 months)
- Change in skeletal muscle mass from baseline to 3 and 6 months(3 and 6 months)
- Change in Time in Range from baseline to 3 months(3 months)