Oral Nutritional Supplement in Type 2 Diabetes Subjects With or at Risk of Malnutrition

Diabetes Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05913193
• Other study ID #: DA31
• Status: Recruiting
• Start date: December 15, 2023
• Est. completion date: February 2025

Study information

• Verified date: February 2024
• Source: Abbott Nutrition
• Contact: Kristen S DeLuca, MS, RDN, LDN
• Phone: 6145653522
• Email: kristen.deluca[@]abbott.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 260
• Est. completion date: February 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Malnutrition

Intervention

Other:
• Oral Nutritional Supplement (ONS)
Diabetes specific oral nutritional supplement

Locations

Country	Name	City	State
Spain	Hospital Albacete	Albacete
Spain	Hospital Vall D'Hebron	Barcelona
Spain	Hospital Uni. Puerta Del Mar	Cadiz
Spain	Hospital Reina Sophia	Córdoba	Cordoba
Spain	Hospital Universitario Jaen	Jaen
Spain	Hospital Clinico San Carlos	Madrid
Spain	Hospital La Paz	Madrid
Spain	Hospital Ramon y Cajal	Madrid
Spain	Hospital Universitario 12 de Octubre	Madrid
Spain	Hospital Especialidades Virgen De La Victoria	Málaga	Malaga
Spain	Hospital Regional Malaga	Málaga	Malaga
Spain	Hospital Virgen Del Rocio	Sevilla
Spain	Hospital Clinico Valencia	Valencia
Spain	Hospital La Fe	Valencia
Spain	Hospital Miguel Servet	Zaragoza

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Nutrition

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Study Product Compliance	Participant completed daily record of nutritional support program	Baseline to Day 90
Other	Participant Satisfaction Survey	Participant assessed 4 questions related to the nutritional support program scored from 1 to 10 where higher number is more favorable	Day 90 or Early Exit
Other	Health Care Professional Satisfaction Survey	Health Care Professional assessed 8 questions related to each Participant's study experience	Day 90 or Early Exit
Other	Medication Usage	Medications prescribed for glucose or appetite control	Baseline to Day 60 to Day 90
Other	Body Mass Index	As calculated from Height and Weight	Baseline to Day 90
Other	Calf Circumference	Measured in cm	Baseline to Day 90
Primary	Nutritional status risk by MUST	Change in status as assessed by the Malnutrition Universal Screening Tool (MUST); Higher score indicates greater risk of malnutrition	Baseline to Day 90
Secondary	Blood Glycemic Measurement	Change in glycemic control markers where lower levels are associated with improved control	Baseline to Day 90
Secondary	Handgrip Strength	Change in handgrip as measured in kg	Baseline to Day 90
Secondary	Chair Stand Test	Change in test score where higher number of times completed is more favorable	Baseline to Day 90
Secondary	Body Composition	Change in body composition where increased fat free mass is more favorable	Baseline to Day 90
Secondary	EQ-5D Quality of Life	Participant assessed 5 Domains; Each Domain scored from 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.	Baseline to Day 90
Secondary	Diabetes Distress Scale	Participant assessed 29 questions rated from 1 to 5 where higher number if less favorable	Baseline to Day 90
Secondary	Subjective Global Assessment	Healthcare Professional completed assessment of 4 components resulting in score where A = Well Nourished, B = Moderately Malnourished, and C = Severely Malnourished	Baseline to Day 90
Secondary	Global Leadership Initiative on Malnutrition (GLIM) Diagnosis of Malnutrition	Change in GLIM as calculated from MUST malnutrition risk and Phenotypic and Etiological Criteria	Baseline to Day 90