Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
163 participants
INTERVENTIONAL
2016-07-01
2018-04-04
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SCREENING
NONE
Study Groups
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Glargine insulin
Single dose glargine insulin (basal component) + regular insulin within total parenteral nutrition (TPN) reservoir (prandial component). 50% of the total calculated dose of insulin is administered subcutaneously as single dose subcutaneous glargine insulin; remaining 50% of the total calculated dose of insulin is administered as regular insulin in the TPN reservoir. Interventions used: Intravenous glargine insulin, and regular insulin added to TPN bag
Subcutaneous glargine insulin
Glargine insuline is an insulin analogue which has a prolonged duration of action. Insulin glargine is obtained by recombinant DNA technology in Escherichia coli.
Regular insulin added to TPN bag
Regular insulin is human insulin produced in Saccharomyces cerevisiae by recombinant DNA technology.
Regular insulin
Regular insulin added to TPN bag (basal + prandial component). The calculated total dose of insulin is administered as regular insulin in the TPN reservoir. Interventions used: Regular insulin added to TPN bag
Regular insulin added to TPN bag
Regular insulin is human insulin produced in Saccharomyces cerevisiae by recombinant DNA technology.
Interventions
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Subcutaneous glargine insulin
Glargine insuline is an insulin analogue which has a prolonged duration of action. Insulin glargine is obtained by recombinant DNA technology in Escherichia coli.
Regular insulin added to TPN bag
Regular insulin is human insulin produced in Saccharomyces cerevisiae by recombinant DNA technology.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Previously diagnosed with diabetes mellitus.
* Hospitalized but without intensive cares.
* Have indication of total parenteral nutritional support (TPN, meaning the covering over 70% of the estimated daily requirements intravenously) for a minimum of 5 days.
* Signature of informed consent.
Exclusion Criteria
* Patients with intensive cares.
* Patients who have been prescribed TPN in intensive cares unity more than 48 hours before admission to hospitalization.
* Intradialytic parenteral nutrition.
* Patients under 18 or pregnant women.
* Patients with renal insufficiency stage 3 B (glomerular filtration rate \< 45 mL / min).
18 Years
ALL
No
Sponsors
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Fundación Pública Andaluza Progreso y Salud
OTHER
Responsible Party
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Principal Investigators
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Gabriel Olveira Fuster, PhD
Role: PRINCIPAL_INVESTIGATOR
Hospital Regional de Malaga
Locations
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Hospital Arquitecto Marcide-Naval
Ferrol, A Coruña, Spain
Hospital de Mérida
Mérida, Badajoz, Spain
Hospital Son Llátzer
Palma de Mallorca, Balearic Islands, Spain
Hospital General Mancha Centro
Alcázar de San Juan, Ciudad Real, Spain
Hospital Universitario Principe de Asturias
Alcalá de Henares, Madrid, Spain
Hospital Universitario de Fuenlabrada
Fuenlabrada, Madrid, Spain
Hospital Universitario Severo Ochoa
Leganés, Madrid, Spain
Hospital Universitario Puerta de Hierro
Majadahonda, Madrid, Spain
Hospital Clínico Universitario Virgen de la Arrixaca
El Palmar, Murcia, Spain
Complejo Hospitalario de Navarra
Pamplona, Navarre, Spain
Hospital de Cabueñes
Gijón, Principality of Asturias, Spain
Complejo Hospitalario Universitario de Albacete
Albacete, , Spain
Hospital General Universitario de Alicante
Alicante, , Spain
Hospital Universitario Infanta Cristina
Badajoz, , Spain
Hospital del Mar
Barcelona, , Spain
Hospital Universitario Bellvitge
Barcelona, , Spain
Hospital de Sant Joan Despi Moisès Broggi (Consorci Sanitari Integral)
Barcelona, , Spain
Hospital Universitario Reina Sofía
Córdoba, , Spain
Hospital Universitario de Guadalajara
Guadalajara, , Spain
Complejo Hospitalario de Jaén
Jaén, , Spain
Complejo Asistencial Universitario de León
León, , Spain
Hospital Universitario Gregorio Marañón
Madrid, , Spain
Fundación Jiménez Díaz
Madrid, , Spain
Hospital Clínico San Carlos
Madrid, , Spain
Hospital Regional Universitario de Málaga
Málaga, , Spain
Hospital Universitario Virgen de la Victoria
Málaga, , Spain
Hospital Universitario Nuestra Señora de la Candelaria
Santa Cruz de Tenerife, , Spain
Hospital Universitario Virgen del Rocío
Seville, , Spain
Hospital Universitario y Politécnico La Fe
Valencia, , Spain
Hospital Clínico Universitario de Valladolid
Valladolid, , Spain
Hospital Clínico Universitario Lozano Blesa
Zaragoza, , Spain
Hospital Universitario Miguel Servet
Zaragoza, , Spain
Countries
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References
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Soria-Utrilla V, Sasso CV, Romero-Zerbo SY, Adarve-Castro A, Lopez-Urdiales R, Herranz-Antolin S, Garcia-Almeida JM, Garcia-Malpartida K, Ferrer-Gomez M, Moreno-Borreguero A, Luengo-Perez LM, Alvarez-Hernandez J, Aragon-Valera C, Ocon-Breton MJ, Garcia-Manzanares A, Breton-Lesmes I, Serrano-Aguayo P, Perez-Ferre N, Lopez-Gomez JJ, Olivares-Alcolea J, Moreno-Martinez M, Tejera-Perez C, Garcia-Arias S, Abad-Gonzalez AL, Alhambra-Exposito MR, Zugasti-Murillo A, Parra-Barona J, Torrejon-Jaramillo S, Abuin J, Fernandez-Garcia JC, Olveira G; Nutrition Area of the Spanish Society of Endocrinology and Nutrition (SEEN). Biomarkers of oxidation, inflammation and intestinal permeability in persons with diabetes mellitus with parenteral nutrition: A multicenter randomized trial. Clin Nutr. 2025 Jan;44:155-164. doi: 10.1016/j.clnu.2024.11.044. Epub 2024 Dec 3.
Olveira G, Abuin J, Lopez R, Herranz S, Garcia-Almeida JM, Garcia-Malpartida K, Ferrer M, Cancer E, Luengo-Perez LM, Alvarez J, Aragon C, Ocon MJ, Garcia-Manzanares A, Breton I, Serrano-Aguayo P, Perez-Ferre N, Lopez-Gomez JJ, Olivares J, Arraiza C, Tejera C, Martin JD, Garcia S, Abad AL, Alhambra MR, Zugasti A, Parra J, Torrejon S, Tapia MJ. Regular insulin added to total parenteral nutrition vs subcutaneous glargine in non-critically ill diabetic inpatients, a multicenter randomized clinical trial: INSUPAR trial. Clin Nutr. 2020 Feb;39(2):388-394. doi: 10.1016/j.clnu.2019.02.036. Epub 2019 Mar 20.
Other Identifiers
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FPS-INSUPAR-2015-01
Identifier Type: -
Identifier Source: org_study_id
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