Blood Sugar; High, Diabetes
Conditions
Keywords
type 2 diabetes, Meal Replacement
Brief summary
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. .
Interventions
DIETARY_SUPPLEMENTMeal Replacement
Meal Replacement
Sponsors
Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Type 2 diabetic patients who meet the diagnosis of type 2 diabetes (CDS2020) and are willing to receive intensive insulin hypoglycemic therapy; 2. Glycated hemoglobin A1c≥7.5%; 3. Age between 18-70 years old, body mass index (BMI) 20-35kg/m2; 4. 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
1. Diagnosed as type 1 diabetes or special type of diabetes; 2. Allergic or intolerable to the meal replacement food used in the study; 3. Acute complications of diabetes (including DKA, HHS, lactic acidosis) 4. 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; 5. Significant macrovascular complications: patients with acute cerebrovascular accident, acute coronary syndrome, peripheral arterial disease requiring vascular intervention or amputation within 12 months before enrollment; 6. 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; 7. 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.; 8. Systemic infection or serious concomitant diseases; patients with malignant tumors or chronic diarrhea; 9. Uncontrolled endocrine gland dysfunction; 10. Mental or communication disorders; 11. Pregnant and lactating women; 12. The subject is not cooperative, or the investigator judges that it may be difficult to complete the investigator; 13. Other circumstances judged by the investigator to be unsuitable for inclusion.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time required for blood sugar to reach target | 7-10days | The time it takes for the patient to reach the prescribed glycemic control goals during the hospital stay |
Countries
China
Outcome results
None listed