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OpenTrials
Completed

NCT Number: NCT05423938

Efficacy of Two ONS 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).

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

José M. García Almeida

Málaga, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Other names: 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

Primary outcomes

  1. Postprandial glycemic response

    Time frame: 180 minutes

Secondary outcomes

  1. Postprandial insulin response

    Time frame: 180 minutes

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

  • Adventia Pharma

Registry information

Official study 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

Acronym: DIACARE

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Jun 21, 2022
Registry last updated
Jun 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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