Clinical trial NCT05913193: Oral Nutritional Supplement in Type 2 Diabetes Subjects With or at Risk of Malnutrition
Official title: High Calorie and High Protein Diabetes-specific Oral Nutritional Supplement in Type 2 Diabetes Subjects With or at Risk of Malnutrition in Real-life Setting: A Post-marketing Observational Study (PMO)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Malnutrition
Diabetes
Lead sponsor: Abbott Nutrition
Sponsor class: INDUSTRY
First posted: 2023-06-22
Enrollment: 260
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult participants with type 2 diabetes receiving an oral nutritional supplement as standard of care will be recruited from the investigator's community population.

Brief summary: This multicenter, prospective study will evaluate the use of a nutritional support program including an oral diabetes-specific nutritional supplement consumed twice a day on the nutritional status of patients with T2D with or at risk of malnutrition.


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes on treatment with one or more oral antidiabetics/insulin and constant dose for at least 2 months
* Has HbA1c \< 9.0% based on recent (30 days prior to Baseline visit) laboratory value or analysis of blood sample obtained at Baseline Visit
* Adult population with age ≥30 years
* Willing to follow the protocol as described
* Voluntarily signed and dated an informed consent form (ICF), approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to any participation in the study to allow their data to be collected
* Subject is under the care of a health care professional for malnutrition, or is at risk for malnutrition (MUST≥1), and has recently (within the last 7 days prior to participating in this study) been prescribed study oral nutritional supplement (2 servings/day) by their health care professional

Exclusion Criteria:

* History of T2D longer than 30 years
* History of diabetic ketoacidosis and or hyperosmolar hyperglycemic state (HHS)
* If on thyroid medication or hormone replacement therapy, has not been on a constant dosage for at least 2 months prior to Baseline Visit
* History of metabolic/endocrine (other than diabetes), hepatic (AST/ALT 3 times the upper normal limit), or significant renal disease (GFR \< 60 ml/min/1.73m2)
* History of heart failure (\> class II)
* Follows a non-typical eating pattern, such as very low carbohydrate diet (e.g., Atkins diet, ketogenic diet, high protein diet), strict vegetarianism (e.g., no meat, dairy, eggs).
* Is pregnant as confirmed via urine pregnancy test, attempting to conceive or not willing and able to practice birth control during the study duration
* Has current infection (requiring medication or which might be expected to require hospitalization); has had inpatient surgery, or corticosteroid treatment (excluding topical creams) in the last 3 months or antibiotics in the last 3 weeks prior to Baseline Visit.
* Has an active malignancy
* Known to be allergic or intolerant to any ingredient found in the study products
* Taking any medications, herbals, or dietary supplements, other than allowed medications, during the past 4 weeks that could profoundly affect (in the opinion of the PI or study physician) blood glucose or appetite modifying medications (examples include orlistat, contrive, incretins, cannabis).
* Has known dementia, eating disorders, history of significant neurological or psychiatric disorder, or any other psychological condition that may interfere with study product consumption AND does not have a caregiver who can assist them with adherence to the study protocol
* Participant in a concomitant AN trial or trial of a nonregistered drug (or is within the 30 days follow-up period for such a trial) or that otherwise conflicts with this study unless otherwise approved by Abbott Nutrition.
* Patient is receiving any other oral supplement with HMB for nutritional management in the last 7 days

Primary outcomes:
measure: Nutritional status risk by MUST
timeFrame: Baseline to Day 90
Secondary outcomes:
measure: Blood Glycemic Measurement
timeFrame: Baseline to Day 90
measure: Handgrip Strength
timeFrame: Baseline to Day 90
measure: Chair Stand Test
timeFrame: Baseline to Day 90
measure: Body Composition
timeFrame: Baseline to Day 90
measure: EQ-5D Quality of Life
timeFrame: Baseline to Day 90
measure: Diabetes Distress Scale
timeFrame: Baseline to Day 90
measure: Subjective Global Assessment
timeFrame: Baseline to Day 90
measure: Global Leadership Initiative on Malnutrition (GLIM) Diagnosis of Malnutrition
timeFrame: Baseline to Day 90
Other outcomes:
measure: Study Product Compliance
timeFrame: Baseline to Day 90
measure: Participant Satisfaction Survey
timeFrame: Day 90 or Early Exit
measure: Health Care Professional Satisfaction Survey
timeFrame: Day 90 or Early Exit
measure: Medication Usage
timeFrame: Baseline to Day 60 to Day 90
measure: Body Mass Index
timeFrame: Baseline to Day 90
measure: Calf Circumference
timeFrame: Baseline to Day 90
Locations:
city: Córdoba
country: Spain
facility: Hospital Reina Sophia
state: Cordoba
city: Málaga
country: Spain
facility: Hospital Especialidades Virgen De La Victoria
state: Malaga
city: Málaga
country: Spain
facility: Hospital Regional Malaga
state: Malaga
city: Albacete
country: Spain
facility: Hospital Albacete
city: Barcelona
country: Spain
facility: Hospital Vall D'Hebron
city: Bilbao
country: Spain
facility: Hospital Universitario Basurto
city: Cadiz
country: Spain
facility: Hospital Uni. Puerta Del Mar
city: Granda
country: Spain
facility: Hospital Virgen De Las Nieves
city: Huelva
country: Spain
facility: Hospital Juhn Romon Jimenez
city: Jaen
country: Spain
facility: Hospital Universitario Jaen
city: Las Palmas De Gran Canaria
country: Spain
facility: Complejo Hospitalario Universitario Insular-Materno infantil
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: Hospital La Paz
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Madrid
country: Spain
facility: Hospital Ramon y Cajal
city: Sevilla
country: Spain
facility: Hospital Virgen Del Rocio
city: Valencia
country: Spain
facility: Hospital Clinico Valencia
city: Valencia
country: Spain
facility: Hospital La Fe
city: Zaragoza
country: Spain
facility: Hospital Miguel Servet
Study officials:
affiliation: Abbott
name: German Guzman, MD
role: STUDY_CHAIR
References: