Status:
UNKNOWN
The Effect of Meal Replacement on the Time to Reach the Blood Glucose Target in Patients With Type 2 Diabetes Mellitus
Lead Sponsor:
Sun Yat-sen University
Conditions:
Diabetes
Blood Sugar; High
Eligibility:
All Genders
18-70 years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2023
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT05365152
Start Date
April 1 2022
End Date
December 31 2023
Last Update
May 9 2022
Active Locations (1)
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1
the First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China, 510000