Study About Adherence and Tolerance of an Oral Nutritional Supplement (ONS) Specific for Diabetic Patient.

NCT05488210 | Unknown

• 1 other identifier: PI-6092
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Diabetes Mellitus (DM) is one of the most prevalent chronic diseases today, it is reaching epidemic proportions, mainly caused by the increase in type 2 diabetes (DM2).The foundation of any hypoglycemic treatment is based on a healthy diet, daily physical exercise and adequate health education with the collaboration of the patient. Diet is sometimes the only necessary therapy since approximately 80% of patients with DM2 are usually overweight, what is mainly wanted with diet is to achieve normal blood glucose levels both fasting and in the postprandial phase. This diet must be a varied diet combining foods from the different food groups; however, carbohydrate control must be one of the key strategies for glycemic control. Currently, there is also talk of the concept of disease-related malnutrition (DRM). DRM is malnutrition associated with a pathological state, with the presence of inflammation being a key factor in determining its etiology. This inflammation can be chronic or acute depending on the type of pathology. Therefore, the fiber and carbohydrate composition of oral nutritional supplements are important for glycemic control, so a study is proposed to evaluate the effect of consuming a ONS hypercaloric/high-protein (HC/HP) with fiber, and enriched in calcium, Vitamin D and DHA on adherence and tolerance of the product and nutritional status in patients with DM2 and malnutrition.

Conditions

Diabetes; Malnutrition

Keywords

DM2; Oral nutritional supplement; Malnourished

Outcome Measures

Primary Outcomes (3)

• Weight gain (kg)

  Changes in body weight. It is measured using a digital scale for clinical use (capacity 0-150 kg),with the person positioned with their back to the viewer, without shoes, wearing a minimum of warm clothing (pants and t-shirt), heels together, looking forward and posture straight body.

  Day 0, Day 60

• Fat mass (%)

  Changes in the percentage (%) of Fat Mass via bioelectrical impedance

  Day 0, Day 60

• Muscle mass (%)

  Changes in the percentage (%) of Muscle Mass via bioelectrical impedance

  Day 0, Day 60

Secondary Outcomes (24)

• Waist circumference (cm)

  Day 0, Day 60

• Body Mass Index (kg/m2)

  Day 0, Day 60

• Extracellular water (%)

  Day 0, Day 60

• Intracellular water (%)

  Day 0, Day 60

• Total Body Water (%)

  Day 0, Day 60

Study Arms (1)

Malnourished DM2 patients

Diabetic patients who present malnutrition through the GLIM criteria

Dietary Supplement: FontActiv DiaBest HP/HC

Interventions

FontActiv DiaBest HP/HC DIETARY_SUPPLEMENT

Daily intake of two FontActiv DiaBest HP/HC during 2 months

Also known as: Experimental

Malnourished DM2 patients

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Diabetic patients who present malnutrition through the GLIM criteria

You may qualify if:

• Men and women enter 18 and 85 years old.
• Patients with DM2 previously diagnosed and controlled.
• Patients with malnutrition diagnosed according to GLIM criteria.
• Patients who require taking ONS.
• Patients willing to consume the ONS during the study period.
• Patients with adequate cultural level and understanding of the clinical study.
• Patients who agree to voluntarily participate in the study and who give their informed consent in writing.

You may not qualify if:

• Subjects with enteral or parenteral nutrition.
• Subjects with poorly controlled DM2.
• Subjects with dementia, eating behavior disorders, history of serious neurological or psychiatric pathology that may interfere with adherence to the consumption of the ONS.
• Subjects suffering from alcoholism or substance abuse that may interfere with adherence to the consumption of the ONS.
• Subjects with a diagnosis of kidney or liver disease under pharmacological treatment.
• Subjects with infections or any condition that interferes with nutrient digestion, absorption, metabolism, or excretion (including gastroparesis).
• Subjects with chronic gastrointestinal diseases that affect the digestion or absorption of nutrients.
• Subjects with allergies or intolerances to any of the ingredients of the formula.
• Subjects with socio-family problems that prevent them from participating in the study.
• Pregnant or lactating women.

Sponsors & Collaborators

• Instituto de Investigación Hospital Universitario La Paz: lead
• Fundació Eurecat: collaborator
• Laboratoires Grand Fontaine S.L: collaborator

Study Sites (1)

Samara Palma Milla

Madrid, 28046, Spain

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus; Malnutrition

Condition Hierarchy (Ancestors)

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

Study Officials

• Samara Palma-Milla, MD, PhD

  Hospital La Paz

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bricia López-Plaza, PhD

CONTACT

917277000; bricia.plaza@idipaz.es

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2022
• First Posted: August 4, 2022
• Study Start: July 1, 2022
• Primary Completion: December 31, 2022
• Study Completion: July 1, 2023
• Last Updated: August 4, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)