NCT05423938

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2019-11-04
• Primary completion: 2022-02-17
• Completion: 2022-02-17
• First posted: 2022-06-21
• Last updated: 2022-06-21

Locations

1 site across 1 country: Spain