Clinical trial NCT05423938: Efficacy of Two ONS in Patients at Nutritional Risk With Type 2 Diabetes Mellitus
Official title: Efficacy of Two Formulas of Oral Nutritional Supplementation on Metabolic Parameters and Glycemic Monitoring in Patients at Nutritional Risk With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Malnutrition
Keywords: ONS
Type 2 diabetes
Malnutrition
EVOO
carbohydrates
glycemic index
Lead sponsor: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Sponsor class: OTHER
Collaborators: name: Adventia Pharma
First posted: 2022-06-21
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized, crossover, double blind, multicenter, clinical trial
Primary purpose: TREATMENT

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Postprandial glycemic response
timeFrame: 180 minutes
Secondary outcomes:
measure: Postprandial insulin response
timeFrame: 180 minutes
Other outcomes:
Locations:
city: Málaga
country: Spain
facility: José M. García Almeida
Study officials:
References: