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

NCT ID: NCT05423938

Last Updated: 2022-06-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-04
• Study Completion Date: 2022-02-17

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).

Conditions

Type 2 Diabetes; Malnutrition

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Bi1 diacare hp-hc

During 6 days, patients received 2 ONS of a specific formula for diabetes, high energy (300 kcal/unit) and high protein (20%), with fiber, EPA\&DHA, EVOO and a specific mix of low glycemic index of carbohydrate

Group Type: EXPERIMENTAL

Diabetic

Intervention Type: DIETARY_SUPPLEMENT

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

During 6 days, patients received 2 ONS of a standar formula, high energy (300 kcal/unit) and high protein (20%), without fiber, without EPA\&DHA, without EVOO and without a specific mix of low glycemic index of carbohydrate

Group Type: ACTIVE_COMPARATOR

Control

Intervention Type: DIETARY_SUPPLEMENT

It is a hypercaloric and hyperproteic dietary supplement formulated without the ingredients to contribute in the glycemia control

Interventions

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

Intervention Type: DIETARY_SUPPLEMENT

Control

It is a hypercaloric and hyperproteic dietary supplement formulated without the ingredients to contribute in the glycemia control

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Bi1 diacare hp-hc

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Adventia Pharma

INDUSTRY

Sponsor Role: collaborator

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

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

José M. García Almeida

Málaga, , Spain

Countries

Spain

Other Identifiers

DIACARE

Identifier Type: -

Identifier Source: org_study_id