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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05913193
Other study ID # DA31
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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