Status:
COMPLETED
Efficacy of Two ONS in Patients at Nutritional Risk With Type 2 Diabetes Mellitus
Lead Sponsor:
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Collaborating Sponsors:
Adventia Pharma
Conditions:
Type 2 Diabetes
Malnutrition
Eligibility:
All Genders
18-85 years
Phase:
NA
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)...
Eligibility Criteria
Inclusion
- 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
- 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/m2.
- 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.
- 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.
- Allergy or intolerance to any component of the products under study.
- Participation in a concurrent trial that conflicts with this study.
Key Trial Info
Start Date :
November 4 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 17 2022
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT05423938
Start Date
November 4 2019
End Date
February 17 2022
Last Update
June 21 2022
Active Locations (1)
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1
José M. García Almeida
Málaga, Spain