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

NCT ID: NCT05365152

Last Updated: 2022-05-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-01
• Study Completion Date: 2023-12-31

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. .

Conditions

Diabetes; Blood Sugar; High

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Meal replacement intervention group

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.

Group Type: EXPERIMENTAL

Meal Replacement

Intervention Type: DIETARY_SUPPLEMENT

Meal Replacement

diabetes diet group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Meal Replacement

Meal Replacement

Intervention Type: DIETARY_SUPPLEMENT

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Yanbing Li

chief physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

the First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Yanbing Li, MD

Role: primary

easd04lyb@126.com

+86 13925111691

Liehua Liu, MD

Role: backup

turkey310@163.com

+86 13751748843

Other Identifiers

2021-793

Identifier Type: -

Identifier Source: org_study_id