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

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

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).

Study Overview

• Status: Completed
• Conditions: Malnutrition; Type 2 Diabetes
• Intervention / Treatment: Dietary supplement: Diabetic; Dietary supplement: Control

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Málaga, Spain
    • José M. García Almeida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	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; Other Names: Bi1 diacare hp-hc
Active Comparator: 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	Dietary supplement: Control; It is a hypercaloric and hyperproteic dietary supplement formulated without the ingredients to contribute in the glycemia control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Postprandial glycemic response	180 minutes

Secondary Outcome Measures

Outcome Measure	Time Frame
Postprandial insulin response	180 minutes

Collaborators and Investigators

• Sponsor: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
• Collaborators: Adventia Pharma

Study record dates

Study Major Dates

• Study Start (Actual): November 4, 2019
• Primary Completion (Actual): February 17, 2022
• Study Completion (Actual): February 17, 2022

Study Registration Dates

• First Submitted: June 14, 2022
• First Submitted That Met QC Criteria: June 14, 2022
• First Posted (Actual): June 21, 2022

Study Record Updates

• Last Update Posted (Actual): June 21, 2022
• Last Update Submitted That Met QC Criteria: June 14, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Type 2 diabetes; glycemic index; Malnutrition; carbohydrates; EVOO; ONS
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Nutrition Disorders; Diabetes Mellitus; Diabetes Mellitus, Type 2; Malnutrition
• Other Study ID Numbers: DIACARE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No