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The purpose of the study is to evaluate the effect of Glucerna SR treating newly-diagnosed type 2 diabetes patients (NDM) on glycemic stability, with the application of CGMS (continuous glucose monitoring system) and to further realize the safety and effect of Glucerna SR on daily and day-to-day amplitude of blood glucose fluctuation.
Glucerna SR (Abbott Laboratories, Columbus, USA) is a nutritional product with lower glycemic response. About 24% of the total energy provided by Glucerna SR is due to monounsaturated fatty acids, which can help keep good metabolic state in accordance with the recommendations of the American Heart Association. The aim of the study is to evaluate the effect of Glucerna SR treating newly-diagnosed type 2 diabetes patients (NDM) on glycemic stability, with the application of CGMS (continuous glucose monitoring system) and to further realize the safety and effect of Glucerna SR consumed as a meal replacement at breakfast meal on daily and day-to-day amplitude of blood glucose fluctuation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study arm | Experimental | Use Glucerna SR as a meal replacement at breakfast meal in the study group, meanwhile patients receive diabetes diet management (Each subject will be individually instructed by a dedicating dietitian how to implement the daily diabetes diet before starting the study.) |
|
| Control arm | No Intervention | Patients only receive diabetes diet management according to the instruction of dedicating dietitian on how to implement the daily diabetes diet. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glucerna SR | Dietary Supplement | Glucerna SR (Abbott Laboratories, Columbus, USA) is a nutritional product with lower glycemic response. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in AUCpp | Subjects will perform continues blood glucose monitoring using CGMS for 72 hours at the beginning of the study and within the last three days during a 4-week treatment interval and AUCpp based on CGMS data was calculated as the area between the glucose concentration-time curve, and the pre-prandial baseline glucose value measured at 4 h after each meal. | 4 weeks |
| Change From Baseline in SDBG | Subjects will perform continues blood glucose monitoring using CGMS for 72 hours at the beginning of the study and within the last three days during a 4-week treatment interval and SDBG will be calculated based on CGMS data. | 4 weeks |
| Change From Baseline in MAGE | Subjects will perform continues blood glucose monitoring using CGMS for 72 hours at the beginning of the study and within the last three days during a 4-week treatment interval and MAGE will be calculated based on CGMS data. | 4 weeks |
| Change From Baseline in Glucose Coefficient of Variation(CV) | Subjects will perform continues blood glucose monitoring using CGMS for 72 hours at the beginning of the study and within the last three days during a 4-week treatment interval and glucose coefficient of variation(CV) will be calculated based on CGMS data dividing the standard deviation of blood glucose values by the mean of the corresponding glucose readings. | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in BMI | the change of BMI between the end and the beginning of the study | 4 weeks |
| Change From Baseline in Systolic Blood Pressure | the change of systolic blood pressure between the end and the beginning of the study |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yuqian Bao, MD | Shanghai Jiao Tong University Affiliated Sixth People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Jiao Tong University Affiliated Sixth People's Hospital | Shanghai | Shanghai Municipality | 200023 | China |
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| ID | Title | Description |
|---|---|---|
| FG000 | Study Arm | Use Glucerna SR as a meal replacement at breakfast meal in the study group, meanwhile patients receive diabetes diet management (Each subject will be individually instructed by a dedicating dietitian how to implement the daily diabetes diet before starting the study.) Glucerna SR: Glucerna SR (Abbott Laboratories, Columbus, USA) is a nutritional product with lower glycemic response. |
| FG001 | Control Arm | Patients only receive diabetes diet management according to the instruction of dedicating dietitian on how to implement the daily diabetes diet. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Study Arm | Use Glucerna SR as a meal replacement at breakfast meal in the study group, meanwhile patients receive diabetes diet management (Each subject will be individually instructed by a dedicating dietitian how to implement the daily diabetes diet before starting the study.) Glucerna SR: Glucerna SR (Abbott Laboratories, Columbus, USA) is a nutritional product with lower glycemic response. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in AUCpp | Subjects will perform continues blood glucose monitoring using CGMS for 72 hours at the beginning of the study and within the last three days during a 4-week treatment interval and AUCpp based on CGMS data was calculated as the area between the glucose concentration-time curve, and the pre-prandial baseline glucose value measured at 4 h after each meal. | The analysis population is subjects who completed the whole study. | Posted | Mean | Standard Deviation | min*mmol/L | 4 weeks |
|
4 weeks
The subjects are newly diagnosed and untreated T2D, so they are not prone to hypoglycemia.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Study Arm | Use Glucerna SR as a meal replacement at breakfast meal in the study group, meanwhile patients receive diabetes diet management (Each subject will be individually instructed by a dedicating dietitian how to implement the daily diabetes diet before starting the study.) Glucerna SR: Glucerna SR (Abbott Laboratories, Columbus, USA) is a nutritional product with lower glycemic response. |
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1.The intervention period was relatively short. 2. The open-label design of the current study may introduce some extent of bias. 3.Only untreated T2D patients were admitted in the study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Yuqian Bao | 6thShanghaiJiaotongU | (021)64369181 | byq522@163.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 31, 2018 | Apr 6, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C530986 | Glucerna |
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| 4 weeks |
| Change From Baseline in Diastolic Blood Pressure | the change of diastolic blood pressure between the end and the beginning of the study | 4 weeks |
| Change From Baseline in TC | the change of total cholesterol between the end and the beginning of the study | 4 weeks |
| Change From Baseline in Triglycerides | the change of triglycerides between the end and the beginning of the study | 4 weeks |
| Change From Baseline in HDL-c | the change of HDL-c between the end and the beginning of the study | 4 weeks |
| Change From Baseline in LDL-c | the change of LDL-c between the end and the beginning of the study | 4 weeks |
| Change From Baseline in FPG | the change of FPG between the end and the beginning of the study | 4 weeks |
| Change From Baseline in 2h-PG | the change of 2h-PG between the end and the beginning of the study | 4 weeks |
| Change From Baseline in HbA1c | the change of HbA1c between the end and the beginning of the study | 4 weeks |
| Change From Baseline in GA | the change of GA between the end and the beginning of the study | 4 weeks |
| Change From Baseline in HOMA-IR | the change of HOMA-IR between the end and the beginning of the study | 4 weeks |
| BG001 | Control Arm | Patients only receive diabetes diet management according to the instruction of dedicating dietitian on how to implement the daily diabetes diet. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m2 |
|
| Systolic Blood Pressure | Mean | Standard Deviation | mmHg |
|
| Diastolic Blood Pressure | Mean | Standard Deviation | mmHg |
|
| Total Cholesterol (TC) | Mean | Standard Deviation | mmol/l |
|
| Triglycerides | Mean | Standard Deviation | mmol/l |
|
| High Density Lipoprotein Cholesterol(HDL-c) | Mean | Standard Deviation | mmol/l |
|
| Low Density Lipoprotein Cholesterol(LDL-c) | Mean | Standard Deviation | mmol/l |
|
| Fasting Plasma Glucose (FPG) | Mean | Standard Deviation | mmol/l |
|
| 2-h Plasma Glucose (2h-PG) | Mean | Standard Deviation | mmol/l |
|
| Glycated Hemoglobin A1c (HbA1c) | Mean | Standard Deviation | percentage of glycated hemoglobin A1c |
|
| Glycated Albumin (GA) | Mean | Standard Deviation | percentage of glycated albumin |
|
| Homeostasis Model Assessments of Insulin Resistance (HOMA-IR) | Mean | Standard Deviation | mU/L*mmol/L |
|
| Incremental AUC of Postprandial Blood Glucose (AUCpp) | Mean | Standard Deviation | min*mmol/l |
|
| Standard Deviation of Blood Glucose (SDBG) | Mean | Standard Deviation | mmol/l |
|
| Mean Amplitude of Glycaemic Excursions (MAGE) | Mean | Standard Deviation | mmol/l |
|
| Glucose Coefficient of Variation(CV) | glucose coefficient of variation (CV) was calculated by dividing the standard deviation of blood glucose values by the mean of the corresponding glucose readings. | Mean | Standard Deviation | percentage of CV |
|
| OG001 | Control Arm | Patients only receive diabetes diet management according to the instruction of dedicating dietitian on how to implement the daily diabetes diet. |
|
|
| Primary | Change From Baseline in SDBG | Subjects will perform continues blood glucose monitoring using CGMS for 72 hours at the beginning of the study and within the last three days during a 4-week treatment interval and SDBG will be calculated based on CGMS data. | The analysis population is subjects who completed the whole study. | Posted | Mean | Standard Deviation | mmol/L | 4 weeks |
|
|
|
| Primary | Change From Baseline in MAGE | Subjects will perform continues blood glucose monitoring using CGMS for 72 hours at the beginning of the study and within the last three days during a 4-week treatment interval and MAGE will be calculated based on CGMS data. | The analysis population is subjects who completed the whole study. | Posted | Mean | Standard Deviation | mmol/L | 4 weeks |
|
|
|
| Primary | Change From Baseline in Glucose Coefficient of Variation(CV) | Subjects will perform continues blood glucose monitoring using CGMS for 72 hours at the beginning of the study and within the last three days during a 4-week treatment interval and glucose coefficient of variation(CV) will be calculated based on CGMS data dividing the standard deviation of blood glucose values by the mean of the corresponding glucose readings. | The analysis population is subjects who completed the whole study. | Posted | Mean | Standard Deviation | percentage of CV | 4 weeks |
|
|
|
| Secondary | Change From Baseline in BMI | the change of BMI between the end and the beginning of the study | The analysis population is subjects who completed the whole study. | Posted | Mean | Standard Deviation | kg/m2 | 4 weeks |
|
|
|
| Secondary | Change From Baseline in Systolic Blood Pressure | the change of systolic blood pressure between the end and the beginning of the study | The analysis population is subjects who completed the whole study. | Posted | Mean | Standard Deviation | mmHg | 4 weeks |
|
|
|
| Secondary | Change From Baseline in Diastolic Blood Pressure | the change of diastolic blood pressure between the end and the beginning of the study | The analysis population is subjects who completed the whole study. | Posted | Mean | Standard Deviation | mmHg | 4 weeks |
|
|
|
| Secondary | Change From Baseline in TC | the change of total cholesterol between the end and the beginning of the study | The analysis population is subjects who completed the whole study. | Posted | Mean | Standard Deviation | mmol/L | 4 weeks |
|
|
|
| Secondary | Change From Baseline in Triglycerides | the change of triglycerides between the end and the beginning of the study | The analysis population is subjects who completed the whole study. | Posted | Mean | Standard Deviation | mmol/L | 4 weeks |
|
|
|
| Secondary | Change From Baseline in HDL-c | the change of HDL-c between the end and the beginning of the study | The analysis population is subjects who completed the whole study. | Posted | Mean | Standard Deviation | mmol/L | 4 weeks |
|
|
|
| Secondary | Change From Baseline in LDL-c | the change of LDL-c between the end and the beginning of the study | The analysis population is subjects who completed the whole study. | Posted | Mean | Standard Deviation | mmol/L | 4 weeks |
|
|
|
| Secondary | Change From Baseline in FPG | the change of FPG between the end and the beginning of the study | The analysis population is subjects who completed the whole study. | Posted | Mean | Standard Deviation | mmol/L | 4 weeks |
|
|
|
| Secondary | Change From Baseline in 2h-PG | the change of 2h-PG between the end and the beginning of the study | The analysis population is subjects who completed the whole study. | Posted | Mean | Standard Deviation | mmol/L | 4 weeks |
|
|
|
| Secondary | Change From Baseline in HbA1c | the change of HbA1c between the end and the beginning of the study | The analysis population is subjects who completed the whole study. | Posted | Mean | Standard Deviation | percentage of HbA1c | 4 weeks |
|
|
|
| Secondary | Change From Baseline in GA | the change of GA between the end and the beginning of the study | The analysis population is subjects who completed the whole study. | Posted | Mean | Standard Deviation | percentage of GA | 4 weeks |
|
|
|
| Secondary | Change From Baseline in HOMA-IR | the change of HOMA-IR between the end and the beginning of the study | The analysis population is subjects who completed the whole study. | Posted | Mean | Standard Deviation | mU/L*mmol/L | 4 weeks |
|
|
|
| 0 |
| 66 |
| 0 |
| 66 |
| 0 |
| 66 |
| EG001 | Control Arm | Patients only receive diabetes diet management according to the instruction of dedicating dietitian on how to implement the daily diabetes diet. | 0 | 65 | 0 | 65 | 0 | 65 |
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| D004700 | Endocrine System Diseases |