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

Primary Purpose

Type 2 Diabetes, Malnutrition

Status

Completed

Phase

Not Applicable

Locations

Spain

Study Type

Interventional

Intervention

Diabetic

Control

About this trial

This is an interventional treatment trial for Type 2 Diabetes focused on measuring ONS, Type 2 diabetes, Malnutrition, EVOO, carbohydrates, glycemic index

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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/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.

Sites / Locations

José M. García Almeida

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Bi1 diacare hp-hc

Control

Arm Description

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

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

Outcomes

Primary Outcome Measures

Postprandial glycemic response

Secondary Outcome Measures

Postprandial insulin response

Full Information

NCT ID

NCT05423938

First Posted

June 14, 2022

Last Updated

June 14, 2022

Sponsor

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

Collaborators

Adventia Pharma

1. Study Identification

Unique Protocol Identification Number

NCT05423938

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2022

Overall Recruitment Status

Completed

Study Start Date

November 4, 2019 (Actual)

Primary Completion Date

February 17, 2022 (Actual)

Study Completion Date

February 17, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

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

Collaborators

Adventia Pharma

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 2 Diabetes, Malnutrition

Keywords

ONS, Type 2 diabetes, Malnutrition, EVOO, carbohydrates, glycemic index

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Model Description

Randomized, crossover, double blind, multicenter, clinical trial

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

29 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Bi1 diacare hp-hc

Arm Type

Experimental

Arm Description

Arm Title

Control

Arm Type

Active Comparator

Arm Description

Intervention Type

Dietary Supplement

Intervention Name(s)

Diabetic

Other Intervention Name(s)

Bi1 diacare hp-hc

Intervention Description

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

Intervention Name(s)

Control

Intervention Description

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

Primary Outcome Measure Information:

Title

Postprandial glycemic response

Time Frame

180 minutes

Secondary Outcome Measure Information:

Title

Postprandial insulin response

Time Frame

180 minutes

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

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/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.

Facility Information:

Facility Name

José M. García Almeida

City

Málaga

Country

Spain

12. IPD Sharing Statement

Plan to Share IPD

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

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