The Effects of Partial Calories Replacement Using Substitute Meals on Glycemic Control During Short-term Insulin Intensive Therapy in Patients With Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Time required for blood sugar to reach target
研究概览
简要总结
This study was designed as a randomized controlled study. It was planned to include 100 patients with type 2 diabetes who received short-term intensive insulin therapy and randomly divided them into a meal replacement intervention group and a conventional diabetes diet group according to 1:1. Both groups were treated with short-term intensive insulin therapy to control blood sugar. .
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
- Single (Care Provider)
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
- •Type 2 diabetic patients who meet the diagnosis of type 2 diabetes (CDS2020) and are willing to receive intensive insulin hypoglycemic therapy;
- •Glycated hemoglobin A1c≥7.5%;
- •Age between 18-70 years old, body mass index (BMI) 20-35kg/m2;
- •Be able and willing to cooperate with diet and exercise and monitor blood sugar in accordance with the project regulations, and agree to sign the informed consent.
排除标准
- •Diagnosed as type 1 diabetes or special type of diabetes;
- •Allergic or intolerable to the meal replacement food used in the study;
- •Acute complications of diabetes (including DKA, HHS, lactic acidosis)
- •Severe microvascular complications: proliferative retinopathy; urine AER>300mg/g or urine protein positive, quantitative>0.5g/d; uncontrolled painful diabetic neuropathy and significant diabetic autonomic neuropathy;
- •Significant macrovascular complications: patients with acute cerebrovascular accident, acute coronary syndrome, peripheral arterial disease requiring vascular intervention or amputation within 12 months before enrollment;
- •Serum creatinine clearance rate is less than 50ml/min/1.73m2 (calculated according to CKDEPI formula), alanine aminotransferase ≥ 3 times the upper limit of normal, and total bilirubin ≥ 2 times the upper limit of normal;
- •The cumulative time of using drugs that may affect blood sugar for more than 1 week within 12 weeks, such as oral/intravenous glucocorticoids, GH, estrogen/progestin, high-dose diuretics, antipsychotics, etc.;
- •Systemic infection or serious concomitant diseases; patients with malignant tumors or chronic diarrhea;
- •Uncontrolled endocrine gland dysfunction;
- •Mental or communication disorders;
- •Pregnant and lactating women;
- •The subject is not cooperative, or the investigator judges that it may be difficult to complete the investigator;
- •Other circumstances judged by the investigator to be unsuitable for inclusion.
研究组 & 干预措施
Meal replacement intervention group
On the day of the patient's admission, the total calories required for the diabetic diet during the hospitalization period were calculated according to "ideal weight * 25/kcal" (BMI > 28, 80% of this value). Carbohydrates, fats, and proteins accounted for 50%, 30%, and 20% of the energy supply, respectively, and the calories of the three meals were distributed according to 1:2:2. The meal replacement intervention group replaced the daily meal with meal replacement on the basis of the conventional diabetic diet. About 400kcal calories in carbohydrates.
干预措施: Meal Replacement (Dietary Supplement)
diabetes diet group
On the day of the patient's admission, the total calories required for the diabetic diet during the hospitalization period were calculated according to "ideal weight * 25/kcal" (BMI > 28, 80% of this value). Carbohydrates, fats, and proteins accounted for 50%, 30%, and 20% of the energy supply, respectively, and the calories of the three meals were distributed according to 1:2:2.
结局指标
主要结局
Time required for blood sugar to reach target
时间窗: 7-10days
The time it takes for the patient to reach the prescribed glycemic control goals during the hospital stay
次要结局
未报告次要终点
研究者
Yanbing Li
chief physician
Sun Yat-sen University