The Effect of Meal Replacement on the Time to Reach the Blood Glucose Target in Patients With Type 2 Diabetes Mellitus

Study Overview
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Brief Summary
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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. .

Official Title
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The Effects of Partial Calories Replacement Using Substitute Meals on Glycemic Control During Short-term Insulin Intensive Therapy in Patients With Type 2 Diabetes

Conditions
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Diabetes, Blood Sugar; High

Intervention / Treatment
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* Dietary Supplement: Meal Replacement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Meal replacement intervention group<br>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. | Dietary Supplement: Meal Replacement<br>* Meal Replacement<br>|
| No Intervention: diabetes diet group<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time required for blood sugar to reach target | The time it takes for the patient to reach the prescribed glycemic control goals during the hospital stay | 7-10days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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type 2 diabetes, Meal Replacement