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The study aims to investigate the effect of a diabetes-specific formula (DSF) used as a (partial) meal replacement on long-term glycemic control and short-term glycemic variability in individuals with type 2 diabetes.
This is a randomized, controlled, parallel study. Eligible participants will be randomly allocated (at 1 :1 ratio) to one of two groups: DSF group or control group.The total expected duration of the study is 97 days.
There are two periods in the study:
i) "Run-in Period" (Study Days -6 to -1): participants will wear the CGMS:Continuous Glucose Monitoring System (FreeStyle Libre Pro) and will be asked to follow and track their diet and physical activity on a daily basis.
ii) "Intervention Period" (Study Days 0 to 90): participants will be randomized into one of the two groups (n = 125 per group): DSF group or control group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diabetes-Specific Formula | Experimental | Diabetes-specific formula 1-2 servings a day and Standard of Care |
|
| Standard of Care | Other | Standard of Care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diabetes-Specific Formula | Other | Diabetes-Specific Formula and Standard of Care |
|
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c Level | Change in HbA1c level from Day 0 to Day 90 | Study Days 0, 45 and 90 |
| Measure | Description | Time Frame |
|---|---|---|
| Glycemic Excursion | Mean Amplitude of Glycemic Excursions (MAGE) | Study Day 1 to Day 7 |
| Glucose | Mean and coefficient of variation (CV) of glucose during the intervention phase |
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Inclusion Criteria:
Adult participants (≥ 21 and ≤ 65 years of age)
Has type 2 diabetes as evidenced with oral anti-diabetic drug(s) at constant dose for at least two months prior to the study and is able to maintain number of medications, type and dose throughout the duration of the study
BMI ≥ 23 and < 35.0 kg/m2
Weight is stable (has maintained current body weight within 3 kg) for the two months prior to the Baseline Visit
Either a male or a non-pregnant, non-lactating female, at least 6 weeks postpartum prior to the Baseline Visit. A urine pregnancy test is required for all female participants unless she is not of childbearing potential, defined as postmenopausal for at least one year prior to the Baseline Visit or surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy).
If the female is of childbearing potential, she is practicing one of the following methods of birth control and will continue through the duration of the study:
If on a chronic medication such as an anti-hypertensive, lipid-lowering, thyroid medication or hormone therapy, the medication number, type and dose were constant for at least two months prior to the Baseline Visit and will continue through the duration of the study
Willingness to follow the protocol as described, including consumption of study product per the protocol and completing any forms/questionnaires needed throughout the study
At least a two-week washout period is needed between the completion of a previous research study that required ingestion of any study food or drug and their start in the current study
The participant is willing to refrain from taking non-study diabetes-specific formulas over the entire course of the study
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Agnes Siew Ling Tey, Ph.D. | Abbott Nutrition | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| International Medical University | Kuala Lumpur | 57000 | Malaysia | |||
| University of Malaya Medical Centre |
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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 |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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Determine the effects of a diabetes-specific formula [1-2 servings per day as a (partial) meal replacement] in addition to standard of care on HbA1c level, in comparison with the standard of care only
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| Standard Of Care | Other | Standard of Care |
|
| Study Day 1 to Day 7 |
| Time of glucose level | Time of glucose level in target, below and above range per day during intervention phase | Study Day 1 to Day 7 |
| Hypoglycemic Episodes | Number of hypoglycemic episodes per day during the intervention phase | Study Day 1 to Day 7 |
| Hyperglycemic Episodes | Number of hyperglycemic episodes per day during the intervention phase | Study Day 1 to Day 7 |
| Kuala Lumpur |
| 59100 |
| Malaysia |
| Klinik Kesihatan Seremban | Seremban | 70300 | Malaysia |
| Phramongkutklao Hospital | Bangkok | 10400 | Thailand |
| Rajavithi Hospital | Bangkok | 10400 | Thailand |
| D004700 | Endocrine System Diseases |