Efficacy of Two ONS in Patients at Nutritional Risk With Type 2 Diabetes Mellitus

Type 2 Diabetes Clinical Trial

— DIACARE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05423938
• Other study ID #: DIACARE
• Status: Completed
• Phase: N/A
• Start date: November 4, 2019
• Est. completion date: February 17, 2022

Study information

• Verified date: June 2022
• Source: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: February 17, 2022
• Est. primary completion date: February 17, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Malnutrition
• Type 2 Diabetes

Intervention

Dietary Supplement:
• Diabetic
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
• Control
It is a hypercaloric and hyperproteic dietary supplement formulated without the ingredients to contribute in the glycemia control

Locations

Country	Name	City	State
Spain	José M. García Almeida	Málaga

Sponsors (2)

Lead Sponsor	Collaborator
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud	Adventia Pharma

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postprandial glycemic response		180 minutes
Secondary	Postprandial insulin response		180 minutes