Phase
Condition
Diabetic Vitreous Hemorrhage
Diabetic Foot Ulcers
Diabetic Retinopathy
Treatment
Oral Nutritional Supplement (ONS)
Clinical Study ID
Ages > 30 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Type 2 diabetes on treatment with one or more oral antidiabetics/insulin andconstant dose for at least 2 months
Has HbA1c < 9.0% based on recent (30 days prior to Baseline visit) laboratory valueor 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 anIndependent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to anyparticipation in the study to allow their data to be collected
Subject is under the care of a health care professional for malnutrition, or is atrisk for malnutrition (MUST≥1), and has recently (within the last 7 days prior toparticipating in this study) been prescribed study oral nutritional supplement (2servings/day) by their health care professional
Exclusion
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 constantdosage for at least 2 months prior to Baseline Visit
History of metabolic/endocrine (other than diabetes), hepatic (AST/ALT 3 times theupper 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., nomeat, dairy, eggs).
Is pregnant as confirmed via urine pregnancy test, attempting to conceive or notwilling and able to practice birth control during the study duration
Has current infection (requiring medication or which might be expected to requirehospitalization); has had inpatient surgery, or corticosteroid treatment (excludingtopical creams) in the last 3 months or antibiotics in the last 3 weeks prior toBaseline 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 allowedmedications, during the past 4 weeks that could profoundly affect (in the opinion ofthe PI or study physician) blood glucose or appetite modifying medications (examplesinclude orlistat, contrive, incretins, cannabis).
Has known dementia, eating disorders, history of significant neurological orpsychiatric disorder, or any other psychological condition that may interfere withstudy product consumption AND does not have a caregiver who can assist them withadherence to the study protocol
Participant in a concomitant AN trial or trial of a nonregistered drug (or is withinthe 30 days follow-up period for such a trial) or that otherwise conflicts with thisstudy unless otherwise approved by Abbott Nutrition.
Patient is receiving any other oral supplement with HMB for nutritional managementin the last 7 days
Study Design
Connect with a study center
Hospital Reina Sophia
Córdoba, Cordoba 14004
SpainActive - Recruiting
Hospital Especialidades Virgen De La Victoria
Málaga, Malaga 29010
SpainActive - Recruiting
Hospital Regional Malaga
Málaga, Malaga 29010
SpainActive - Recruiting
Hospital Albacete
Albacete, 02008
SpainSite Not Available
Hospital Vall D'Hebron
Barcelona, 08035
SpainSite Not Available
Hospital Universitario Basurto
Bilbao, 48013
SpainActive - Recruiting
Hospital Uni. Puerta Del Mar
Cadiz, 11009
SpainActive - Recruiting
Hospital Virgen De Las Nieves
Granda, 18014
SpainActive - Recruiting
Hospital Juhn Romon Jimenez
Huelva, 21005
SpainActive - Recruiting
Hospital Universitario Jaen
Jaen, 23007
SpainActive - Recruiting
Complejo Hospitalario Universitario Insular-Materno infantil
Las Palmas De Gran Canaria, 35016
SpainActive - Recruiting
Hospital Clinico San Carlos
Madrid, 28050
SpainActive - Recruiting
Hospital La Paz
Madrid, 28046
SpainActive - Recruiting
Hospital Ramon y Cajal
Madrid,
SpainActive - Recruiting
Hospital Universitario 12 de Octubre
Madrid, 28041
SpainActive - Recruiting
Hospital Virgen Del Rocio
Sevilla, 41013
SpainActive - Recruiting
Hospital Clinico Valencia
Valencia, 46010
SpainActive - Recruiting
Hospital La Fe
Valencia, 46026
SpainActive - Recruiting
Hospital Miguel Servet
Zaragoza, 50009
SpainActive - Recruiting
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