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

NCT05423938 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2022-06-21

No results posted yet for this study

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

Interventions

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

DIETARY_SUPPLEMENT

Control

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

Sponsors & Collaborators

  • Adventia Pharma

    collaborator INDUSTRY

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

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-04
Primary Completion
2022-02-17
Completion
2022-02-17

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05423938 on ClinicalTrials.gov