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

Diabetes Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05365152
• Other study ID #: 2021-793
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: May 2022
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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. .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Blood Sugar; High
• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Hyperglycemia

Intervention

Dietary Supplement:
• Meal Replacement
Meal Replacement

Locations

Country	Name	City	State
China	the First Affiliated Hospital of Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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