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This multicenter, prospective study will evaluate the use of a nutritional support program including an oral diabetes-specific nutritional supplement consumed twice a day on the nutritional status of patients with T2D with or at risk of malnutrition.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral Nutritional Supplement (ONS) Group | 2 servings per day as per standard of care during the study period |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral Nutritional Supplement (ONS) | Other | Diabetes specific oral nutritional supplement |
|
| Measure | Description | Time Frame |
|---|---|---|
| Nutritional status risk by MUST | Change in status as assessed by the Malnutrition Universal Screening Tool (MUST); Higher score indicates greater risk of malnutrition | Baseline to Day 90 |
| Measure | Description | Time Frame |
|---|---|---|
| Blood Glycemic Measurement | Change in glycemic control markers where lower levels are associated with improved control | Baseline to Day 90 |
| Handgrip Strength | Change in handgrip as measured in kg |
| Measure | Description | Time Frame |
|---|---|---|
| Study Product Compliance | Participant completed daily record of nutritional support program | Baseline to Day 90 |
| Participant Satisfaction Survey | Participant assessed 4 questions related to the nutritional support program scored from 1 to 10 where higher number is more favorable |
Inclusion Criteria:
Exclusion Criteria:
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Adult participants with type 2 diabetes receiving an oral nutritional supplement as standard of care will be recruited from the investigator's community population.
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| Name | Affiliation | Role |
|---|---|---|
| German Guzman, MD | Abbott | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Reina Sophia | Córdoba | Cordoba | 14004 | Spain | ||
| Hospital Especialidades Virgen De La Victoria |
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| ID | Term |
|---|---|
| D044342 | Malnutrition |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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| Baseline to Day 90 |
| Chair Stand Test | Change in test score where higher number of times completed is more favorable | Baseline to Day 90 |
| Body Composition | Change in body composition where increased fat free mass is more favorable | Baseline to Day 90 |
| EQ-5D Quality of Life | Participant assessed 5 Domains; Each Domain scored from 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. | Baseline to Day 90 |
| Diabetes Distress Scale | Participant assessed 29 questions rated from 1 to 5 where higher number if less favorable | Baseline to Day 90 |
| Subjective Global Assessment | Healthcare Professional completed assessment of 4 components resulting in score where A = Well Nourished, B = Moderately Malnourished, and C = Severely Malnourished | Baseline to Day 90 |
| Global Leadership Initiative on Malnutrition (GLIM) Diagnosis of Malnutrition | Change in GLIM as calculated from MUST malnutrition risk and Phenotypic and Etiological Criteria | Baseline to Day 90 |
| Day 90 or Early Exit |
| Health Care Professional Satisfaction Survey | Health Care Professional assessed 8 questions related to each Participant's study experience | Day 90 or Early Exit |
| Medication Usage | Medications prescribed for glucose or appetite control | Baseline to Day 60 to Day 90 |
| Body Mass Index | As calculated from Height and Weight | Baseline to Day 90 |
| Calf Circumference | Measured in cm | Baseline to Day 90 |
| Málaga |
| Malaga |
| 29010 |
| Spain |
| Hospital Regional Malaga | Málaga | Malaga | 29010 | Spain |
| Hospital Universitario Basurto | Bilbao | 48013 | Spain |
| Hospital Uni. Puerta Del Mar | Cadiz | 11009 | Spain |
| Hospital Virgen De Las Nieves | Granda | 18014 | Spain |
| Hospital Juhn Romon Jimenez | Huelva | 21005 | Spain |
| Hospital Universitario Jaen | Jaén | 23007 | Spain |
| Complejo Hospitalario Universitario Insular-Materno infantil | Las Palmas de Gran Canaria | 35016 | Spain |
| Hospital Universitario 12 de Octubre | Madrid | 28041 | Spain |
| Hospital La Paz | Madrid | 28046 | Spain |
| Hospital Clinico San Carlos | Madrid | 28050 | Spain |
| Hospital Ramon y Cajal | Madrid | Spain |
| Hospital Virgen Del Rocio | Seville | 41013 | Spain |
| Hospital Clinico Valencia | Valencia | 46010 | Spain |
| Hospital La Fe | Valencia | 46026 | Spain |
| Hospital Miguel Servet | Zaragoza | 50009 | Spain |
| D004700 | Endocrine System Diseases |