Oral Nutritional Supplement in Type 2 Diabetes Subjects With or at Risk of Malnutrition
- Conditions
- MalnutritionDiabetes
- Interventions
- Other: Oral Nutritional Supplement (ONS)
- Registration Number
- NCT05913193
- Lead Sponsor
- Abbott Nutrition
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 260
- Type 2 diabetes on treatment with one or more oral antidiabetics/insulin and constant dose for at least 2 months
- Has HbA1c < 9.0% based on recent (30 days prior to Baseline visit) laboratory value or analysis of blood sample obtained at Baseline Visit
- Adult population with age ≥30 years
- Willing to follow the protocol as described
- Voluntarily signed and dated an informed consent form (ICF), approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to any participation in the study to allow their data to be collected
- Subject is under the care of a health care professional for malnutrition, or is at risk for malnutrition (MUST≥1), and has recently (within the last 7 days prior to participating in this study) been prescribed study oral nutritional supplement (2 servings/day) by their health care professional
- History of T2D longer than 30 years
- History of diabetic ketoacidosis and or hyperosmolar hyperglycemic state (HHS)
- If on thyroid medication or hormone replacement therapy, has not been on a constant dosage for at least 2 months prior to Baseline Visit
- History of metabolic/endocrine (other than diabetes), hepatic (AST/ALT 3 times the upper normal limit), or significant renal disease (GFR < 60 ml/min/1.73m2)
- History of heart failure (> class II)
- Follows a non-typical eating pattern, such as very low carbohydrate diet (e.g., Atkins diet, ketogenic diet, high protein diet), strict vegetarianism (e.g., no meat, dairy, eggs).
- Is pregnant as confirmed via urine pregnancy test, attempting to conceive or not willing and able to practice birth control during the study duration
- Has current infection (requiring medication or which might be expected to require hospitalization); has had inpatient surgery, or corticosteroid treatment (excluding topical creams) in the last 3 months or antibiotics in the last 3 weeks prior to Baseline Visit.
- Has an active malignancy
- Known to be allergic or intolerant to any ingredient found in the study products
- Taking any medications, herbals, or dietary supplements, other than allowed medications, during the past 4 weeks that could profoundly affect (in the opinion of the PI or study physician) blood glucose or appetite modifying medications (examples include orlistat, contrive, incretins, cannabis).
- Has known dementia, eating disorders, history of significant neurological or psychiatric disorder, or any other psychological condition that may interfere with study product consumption AND does not have a caregiver who can assist them with adherence to the study protocol
- Participant in a concomitant AN trial or trial of a nonregistered drug (or is within the 30 days follow-up period for such a trial) or that otherwise conflicts with this study unless otherwise approved by Abbott Nutrition.
- Patient is receiving any other oral supplement with HMB for nutritional management in the last 7 days
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Oral Nutritional Supplement (ONS) Group Oral Nutritional Supplement (ONS) 2 servings per day as per standard of care during the study period
- Primary Outcome Measures
Name Time Method Nutritional status risk by MUST Baseline to Day 90 Change in status as assessed by the Malnutrition Universal Screening Tool (MUST); Higher score indicates greater risk of malnutrition
- Secondary Outcome Measures
Name Time Method Blood Glycemic Measurement Baseline to Day 90 Change in glycemic control markers where lower levels are associated with improved control
Handgrip Strength Baseline to Day 90 Change in handgrip as measured in kg
EQ-5D Quality of Life Baseline to Day 90 Participant assessed 5 Domains; Each Domain scored from 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.
Subjective Global Assessment Baseline to Day 90 Healthcare Professional completed assessment of 4 components resulting in score where A = Well Nourished, B = Moderately Malnourished, and C = Severely Malnourished
Global Leadership Initiative on Malnutrition (GLIM) Diagnosis of Malnutrition Baseline to Day 90 Change in GLIM as calculated from MUST malnutrition risk and Phenotypic and Etiological Criteria
Chair Stand Test Baseline to Day 90 Change in test score where higher number of times completed is more favorable
Body Composition Baseline to Day 90 Change in body composition where increased fat free mass is more favorable
Diabetes Distress Scale Baseline to Day 90 Participant assessed 29 questions rated from 1 to 5 where higher number if less favorable
Trial Locations
- Locations (19)
Hospital Universitario Basurto
🇪🇸Bilbao, Spain
Hospital Uni. Puerta Del Mar
🇪🇸Cadiz, Spain
Hospital Virgen De Las Nieves
🇪🇸Granda, Spain
Hospital Juhn Romon Jimenez
🇪🇸Huelva, Spain
Hospital Universitario Jaen
🇪🇸Jaen, Spain
Hospital Vall D'Hebron
🇪🇸Barcelona, Spain
Hospital La Paz
🇪🇸Madrid, Spain
Hospital Clinico San Carlos
🇪🇸Madrid, Spain
Hospital Ramon y Cajal
🇪🇸Madrid, Spain
Hospital Virgen Del Rocio
🇪🇸Sevilla, Spain
Hospital Clinico Valencia
🇪🇸Valencia, Spain
Hospital La Fe
🇪🇸Valencia, Spain
Hospital Miguel Servet
🇪🇸Zaragoza, Spain
Hospital Regional Malaga
🇪🇸Málaga, Malaga, Spain
Hospital Albacete
🇪🇸Albacete, Spain
Hospital Reina Sophia
🇪🇸Córdoba, Cordoba, Spain
Hospital Especialidades Virgen De La Victoria
🇪🇸Málaga, Malaga, Spain
Complejo Hospitalario Universitario Insular-Materno infantil
🇪🇸Las Palmas De Gran Canaria, Spain
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain