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

NCT05423938 | Completed

• 1 other identifier: DIACARE
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Postprandial glycemic response

  180 minutes

Secondary Outcomes (1)

• Postprandial insulin response

  180 minutes

Study Arms (2)

Bi1 diacare hp-hc

EXPERIMENTAL

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

Control

ACTIVE COMPARATOR

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

Interventions

Diabetic 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

Also known as: Bi1 diacare hp-hc

Bi1 diacare hp-hc

Control DIETARY_SUPPLEMENT

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

Control

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

José M. García Almeida

Málaga, Spain

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Malnutrition

Interventions

Diet, Diabetic

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Nutrition Disorders

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, crossover, double blind, multicenter, clinical trial

Study Record Dates

• First Submitted: June 14, 2022
• First Posted: June 21, 2022
• Study Start: November 4, 2019
• Primary Completion: February 17, 2022
• Study Completion: February 17, 2022
• Last Updated: June 21, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)