Malnutrition, Type 2 Diabetes
Conditions
Keywords
ONS, Type 2 diabetes, Malnutrition, EVOO, carbohydrates, glycemic index
Brief summary
Rationale: The aim of the study was to compare the glycemic and insulinemic response of malnourished patients with type 2 diabetes after oral feed between a diabetic oral nutritional supplements (ONS) and a standard one. Methods: Randomized, double-blind, crossover, multicenter clinical trial, conducted in patients with type 2 diabetes and a diagnosis of malnutrition (SGA). Patients were randomized to receive two ONS: diabetic (Bi1 diacare hp/hc) or control (standard, isocaloric and isoproteic), a week apart. A glycemia and insulinemia curve was made at times: 0', 30', 60', 90', 120', and 180', after drank 200 ml of the ONS. The analyzed variables were the area under the curve (AUC 0-t) of glucosa and insulin, and the maximum concentration of glucose (Cmax).
Interventions
DIETARY_SUPPLEMENTDiabetic
It is a hypercaloric and hyperproteic dietary supplement formulated to contribute to control the glycemia with: a specific mix of carbohydrate with a low GI, fiber, EVOO and EPA&DHA
DIETARY_SUPPLEMENTControl
It is a hypercaloric and hyperproteic dietary supplement formulated without the ingredients to contribute in the glycemia control
Sponsors
Adventia Pharma
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Randomized, crossover, double blind, multicenter, clinical trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosed with DM2 (confirmed by the use of oral hypoglycemic agents for at least two months). * Patients at nutritional risk diagnosed through the Subjective Global Assessment. * Adequate cultural level and understanding of the clinical study. * Agree to voluntarily participate in the study and give their informed consent in writing. * Non-pregnant and non-lactating women or women who have given birth at least six weeks prior to the screening visit.
Exclusion criteria
1. Type 1 DM, DM2 with insulin treatment and DM secondary to steroids. 2. Consumption of alpha-glucosidase inhibitors. 3. Current infection (requiring medication or hospitalization), patients undergoing inpatient surgery, or receiving corticosteroids within the past three months or antibiotics within the past three weeks prior to Screening Visit. 4. BMI \> 35 Kg/m2. 5. Active malignant neoplasm (except the following dermal malignancies: basal cell carcinoma, squamous cell carcinoma, carcinoma in situ of the cervix uteri). 6. End-stage organ failure (such as end-stage renal disease) or organ transplant. 7. Advanced chronic kidney disease (glomerular filtration rate \< 30 ml/min). 8. Severe liver disease. 9. Severe gastroparesis. 10. Chronic infectious disease, such as active tuberculosis, hepatitis B or C, or HIV infection. 11. Consumption of phytotherapy products, dietary supplements or medications except oral hypoglycemic agents, during the four weeks prior to the screening visit, which could profoundly affect (in the opinion of the PI) blood glucose. 12. Allergy or intolerance to any component of the products under study. 13. Participation in a concurrent trial that conflicts with this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Postprandial glycemic response | 180 minutes |
Secondary
| Measure | Time frame |
|---|---|
| Postprandial insulin response | 180 minutes |
Countries
Spain
Outcome results
None listed