Efficacy of Two Formulas of Oral Nutritional Supplementation on Metabolic Parameters and Glycemic Monitoring in Patients at Nutritional Risk With Type 2 Diabetes Mellitus

Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud1 site in 1 country29 target enrollmentNovember 4, 2019

ConditionsType 2 Diabetes Malnutrition

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Type 2 Diabetes
Sponsor: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Enrollment: 29
Locations: 1
Primary Endpoint: Postprandial glycemic response
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

November 4, 2019

End Date

February 17, 2022

Last Updated

3 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud

Responsible Party

Sponsor

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

•Type 1 DM, DM2 with insulin treatment and DM secondary to steroids.
•Consumption of alpha-glucosidase inhibitors.
•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.
•BMI \> 35 Kg/m
•Active malignant neoplasm (except the following dermal malignancies: basal cell carcinoma, squamous cell carcinoma, carcinoma in situ of the cervix uteri).
•End-stage organ failure (such as end-stage renal disease) or organ transplant.
•Advanced chronic kidney disease (glomerular filtration rate \< 30 ml/min).
•Severe liver disease.
•Severe gastroparesis.
•Chronic infectious disease, such as active tuberculosis, hepatitis B or C, or HIV infection.