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| Name | Class |
|---|---|
| Ramathibodi Hospital | OTHER |
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Hypothesis: the diabetes-specific formula Nutren diabetes provides better postprandial glucose control in patients with type 2 diabetes when compared to the isocaloric diet.
This study is an open label, randomized controlled cross-over study
Research objectives:
Statistical analysis method
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Active Comparator | Group A: Drinking Nutren Diabetes provides energy at 360 kcal per 360 ml |
|
| Group B | Placebo Comparator | Group B: Having Isocaloric diet provide 360 kcal. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nutren Diabetes | Other | Nutren Diabetes provides energy at 360 kcal per 360 ml |
|
| Measure | Description | Time Frame |
|---|---|---|
| 2-hour postprandial glucose | The primary outcome will be the difference of 2-hour postprandial glucose between group A and group B | Change form baseline blood glucose level at 30,60, and 120 min. |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the curve of postprandial plasma glucose (AUC glucose 0-120 min) | The secondary outcome will be the difference of AUC glucose 0-120 min between group A and group B. Blood samples will be collected to assess plasma glucose at baseline and 30, 60, 120-minute postprandial. We will calculate the area under the curve of plasma glucose of patients in each arm at baseline and, 30, 60, 120 minute postprandial (AUC glucose 0-120 min) . Blood samples will be collected to assess plasma insulin at baseline and 30, 60, 120-minute postprandial. We will calculate the area under the curve of plasma insulin of patients in each arm at baseline and, 30, 60, 120 minute postprandial (AUC insulin 0-120 min) . |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daruneewan Warodomwichit | Division of Nutrition & Biochemical Medicine, Department of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Division of Nutrition & Biochemical Medicine, Department of Medicine | Bangkok | 10400 | Thailand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25458669 | Result | Gulati S, Misra A, Nanda K, Pandey RM, Garg V, Ganguly S, Cheung L. Efficacy and tolerance of a diabetes specific formula in patients with type 2 diabetes mellitus: An open label, randomized, crossover study. Diabetes Metab Syndr. 2015 Oct-Dec;9(4):252-7. doi: 10.1016/j.dsx.2014.10.001. Epub 2014 Nov 1. |
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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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This is an open-label, randomized cross-over study.
The study date will be 1 day for group A and 1 day for group B, separated by 7-day wash out period.
The tolerability of DSF, assessed by questionnaire, will be collected while the subjects consume DSFs daily 7 days before the study date (only group A). The questionnaire will ask about gastrointestinal symptom including abdominal distention, nausea, vomiting, and stool frequency.
Group A participants will be asked to drink 360 ml of Nutren Diabetes which provides 360 kcal.
Group B participants will be asked to consume isocaloric diet (360 kcal)comprising one carton of soy milk (250 ml) and bologna and mayonnaise sandwiches (two slices of bread).
Plasma glucose and insulin will be collected at baseline (minute 0) and 30, 60, 120 minute postprandially. The participants will be asked to complete the questionnaire (Visual analog scale) to assess hunger and satiety at minute 0, 30, 60 and 120 minute.
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| Isocaloric | Other | Isocaloric diet One carton of soy milk (250 ml) and bologna sandwiches (two slices of bread) with mayonnaise |
|
| Time Frame: Postprandial blood glucose response at 0, 30, 60,120 min |
| Area under the curve of postprandial plasma insulin (AUC insulin 0-120 min) | The secondary outcome will be the difference of AUC insulin 0-120 min between group A and group B. | Postprandial plasma insulin response at 0, 30, 60,120 min |
| Gastrointestinal tolerance | Gastrointestinal tolerance including abdominal distention, nausea, vomiting, and stool frequency will be assessed by questionnaire. We will collect the symptom of GI tolerance everyday during the period that the patient consumes Nutren diabetes and isocaloric diet (7 days before the study date; only participants in group A ) | 7 days prior to the treatment phase. |
| D004700 | Endocrine System Diseases |