Back to resultsThe Effect of Meal Replacement on the Time to Reach the Blood Glucose Target in Patients With Type 2 Diabetes Mellitus
Primary Purpose
Diabetes, Blood Sugar; High
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Meal Replacement
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes focused on measuring type 2 diabetes, Meal Replacement
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
Sites / Locations
- the First Affiliated Hospital of Sun Yat-sen UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Meal replacement intervention group
diabetes diet group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05365152
Brief Title
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
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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. .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Blood Sugar; High
Keywords
type 2 diabetes, Meal Replacement
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Meal replacement intervention group
Arm Type
Experimental
Arm Description
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.
Arm Title
diabetes diet group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Meal Replacement
Intervention Description
Meal Replacement
Primary Outcome Measure Information:
Title
Time required for blood sugar to reach target
Description
The time it takes for the patient to reach the prescribed glycemic control goals during the hospital stay
Time Frame
7-10days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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.
Facility Information:
Facility Name
the First Affiliated Hospital of Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yanbing Li, MD
Phone
+86 13925111691
Email
easd04lyb@126.com
First Name & Middle Initial & Last Name & Degree
Liehua Liu, MD
Phone
+86 13751748843
Email
turkey310@163.com
First Name & Middle Initial & Last Name & Degree
Yanbing Li, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effect of Meal Replacement on the Time to Reach the Blood Glucose Target in Patients With Type 2 Diabetes Mellitus
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