Clinical trial NCT05365152: The Effect of Meal Replacement on the Time to Reach the Blood Glucose Target in Patients With Type 2 Diabetes Mellitus
Official title: The Effects of Partial Calories Replacement Using Substitute Meals on Glycemic Control During Short-term Insulin Intensive Therapy in Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes
Blood Sugar; High
Keywords: type 2 diabetes
Meal Replacement
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2022-05-09
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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. .


Eligibility criteria: 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.

Primary outcomes:
measure: Time required for blood sugar to reach target
timeFrame: 7-10days
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: the First Affiliated Hospital of Sun Yat-sen University
state: Guangdong
Study officials:
References: