Clinical trial NCT05488210: Study About Adherence and Tolerance of an Oral Nutritional Supplement (ONS) Specific for Diabetic Patient.
Official title: Study to Evaluate the Effect of Consuming an Oral Nutritional Supplement (ONS) Specifically for Diabetic Patients on Adherence and Gastrointestinal Tolerance and Nutritional Status in Patients With DM2 and Malnutrition
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diabetes
Malnutrition
Keywords: DM2
Oral nutritional supplement
Malnourished
Lead sponsor: Instituto de Investigación Hospital Universitario La Paz
Sponsor class: OTHER
Collaborators: name: Fundació Eurecat
name: Laboratoires Grand Fontaine S.L
First posted: 2022-08-04
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Diabetic patients who present malnutrition through the GLIM criteria

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.

Detailed description: Longitudinal, prospective exploratory study, to evaluate the effect of consuming an oral nutritional supplement (ONS) HC/HP with fiber, and enriched in calcium, Vitamin D and Docosahexaenoic acid (DHA) on adherence and tolerance of the product and nutritional status in patients with DM2 and malnutrition, in a period of 60 days. Twenty-four volunteers will be recruited at the La Paz University Hospital of Madrid. Participants should meet the next inclusion criteria: men and woman enter 18 and 85, with DM2 previously diagnosed and controlled, with malnutrition diagnosed according to the Global Leadership Initiative on Malnutrition (GLIM) criteria, who require taking ONS, willing to consume the ONS during the study and adequate cultural level and understanding of the clinical study. Follow up will include 4 individualized visits.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Weight gain (kg)
timeFrame: Day 0, Day 60
measure: Fat mass (%)
timeFrame: Day 0, Day 60
measure: Muscle mass (%)
timeFrame: Day 0, Day 60
Secondary outcomes:
measure: Waist circumference (cm)
timeFrame: Day 0, Day 60
measure: Body Mass Index (kg/m2)
timeFrame: Day 0, Day 60
measure: Extracellular water (%)
timeFrame: Day 0, Day 60
measure: Intracellular water (%)
timeFrame: Day 0, Day 60
measure: Total Body Water (%)
timeFrame: Day 0, Day 60
measure: Phase angle (º)
timeFrame: Day 0, Day 60
measure: Body Cell Mass (%)
timeFrame: Day 0, Day 60
measure: Albumin serum concentration (g/dL)
timeFrame: Day 0, Day 60
measure: Prealbumin serum concentration (mg/dL)
timeFrame: Day 0, Day 60
measure: Glucose serum concentration (mg/dL)
timeFrame: Day 0, Day 60
measure: Insulin serum concentration (IU/mL)
timeFrame: Day 0, Day 60
measure: HbA1c serum concentration (%)
timeFrame: Day 0, Day 60
measure: Total Cholesterol serum concentration (mg/dL)
timeFrame: Day 0, Day 60
measure: Triglycerides serum concentration (mg/dL)
timeFrame: Day 0, Day 60
measure: LDL-cholesterol serum concentration (mg/dL)
timeFrame: Day 0, Day 60
measure: HDL-cholesterol serum concentration (mg/dL)
timeFrame: Day 0, Day 60
measure: Creatinine serum concentration (mg/dL)
timeFrame: Day 0, Day 60
measure: Urate serum concentration (mg/dL)
timeFrame: Day 0, Day 60
measure: Adherence to the Mediterranean Diet
timeFrame: Day 0, Day 60
measure: 24 hour food record questionnaire
timeFrame: Day 0, Day 60
measure: International Physical Activity Questionnaire (IPAQ)
timeFrame: Day 0, Day 60
measure: Questionnaire on quality of life (EuroQoL 5D)
timeFrame: Day 0, Day 60
measure: Gastrointestinal symptoms rating scale (GSRS)
timeFrame: Day 0, Day 60
measure: Sensory perception
timeFrame: Day 0, Day 60
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Samara Palma Milla
Study officials:
affiliation: Hospital La Paz
name: Samara Palma-Milla, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: