Insulin in Total Parenteral Nutrition

NCT02706119 | Completed Phase 4

• 1 other identifier: FPS-INSUPAR-2015-01
• Study Type: interventional
• Target: 163
• Locations: 1 country
• Sites: 32

Brief Summary

Analyze the level of metabolic control achieved with a routine of regular insulin in the parenteral nutrition (PN) reservoir in addition to subcutaneous glargine insulin, versus only regular insulin in the PN reservoir.

Conditions

Diabetes Mellitus

Keywords

total parenteral nutrition; glargine insulin; insulin

Outcome Measures

Primary Outcomes (7)

• Basal blood glucose value before starting TPN

  Basal glucose value before starting TPN (in mg/dL).

  Before starting total parenteral nutrition

• Periodical blood glucose

  All blood glucose values (in mg/dL) every 6 hours during 15 days of TPN infusion.

  Every 6h during 15 days of treatment

• Variation of average blood glucose compared with total dose of insulin

  Variation of average glucose (in mg/dL) compared with total dose of insulin (in mL), in days 1, 5 and 15 of treatment.

  In days 1, 5 and 15 of treatment

• Number of hypoglycaemia

  Number of symptomatic and asymptomatic hypoglycaemia with blood glucose below 70 mg/dL during TPN treatment up to 15 days.

  During TPN treatment up to 15 days

• Number of severe hypoglycaemia

  Number of symptomatic and asymptomatic hypoglycaemia with blood glucose below 40 mg/dL during TPN treatment up to 15 days.

  During TPN treatment up to 15 days

• Hypoglycemia blood glucose values

  If the patient refers typical symptoms of hypoglycemia, a measure of blood glucose (in mg/mL) is immediately taken to check the level

  Through study completion, an average of 15 days.

• Hypoglycemia symptoms

  If blood glucose \<70 mg / dL, it is recorded whether or not the patient has symptoms consistent with hypoglycemia and how the episode terminates

  Through study completion, an average of 15 days.

Secondary Outcomes (2)

• Standard deviation of blood glucose

  At day 15 of treatment

• Blood glucose coefficient of variation (CV)

  At day 15 of treatment

Other Outcomes (11)

• Infections related with catheter used in parenteral nutrition

  At day 15 of treatment

• Hypertriglyceridemia

  Every 6h during 15 days of treatment.

• Hypernatremia

  Every 6h during 15 days of treatment.

Study Arms (2)

Glargine insulin

EXPERIMENTAL

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

Drug: Subcutaneous glargine insulin; Drug: Regular insulin added to TPN bag

Regular insulin

ACTIVE COMPARATOR

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

Drug: Regular insulin added to TPN bag

Interventions

Subcutaneous glargine insulin DRUG

Glargine insuline is an insulin analogue which has a prolonged duration of action. Insulin glargine is obtained by recombinant DNA technology in Escherichia coli.

Also known as: ATC code A10AE0, Lantus®, Abasaglar®

Glargine insulin

Regular insulin added to TPN bag DRUG

Regular insulin is human insulin produced in Saccharomyces cerevisiae by recombinant DNA technology.

Also known as: ATC code A10AB01, Actrapid®

Glargine insulin; Regular insulin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults (\>18 years)
• 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.

You may not qualify if:

• Diabetes mellitus type 1, diabetes secondary to total pancreatectomy.
• 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).

Sponsors & Collaborators

• Fundación Pública Andaluza Progreso y Salud: lead

Study Sites (32)

Hospital Arquitecto Marcide-Naval

Ferrol, A Coruña, 15405, Spain

Location

Hospital de Mérida

Mérida, Badajoz, 06800, Spain

Location

Hospital Son Llátzer

Palma de Mallorca, Balearic Islands, 07198, Spain

Location

Hospital General Mancha Centro

Alcázar de San Juan, Ciudad Real, 13600, Spain

Location

Hospital Universitario Principe de Asturias

Alcalá de Henares, Madrid, 28805, Spain

Location

Hospital Universitario de Fuenlabrada

Fuenlabrada, Madrid, 28942, Spain

Location

Hospital Universitario Severo Ochoa

Leganés, Madrid, 28911, Spain

Location

Hospital Universitario Puerta de Hierro

Majadahonda, Madrid, 28222, Spain

Location

Hospital Clínico Universitario Virgen de la Arrixaca

El Palmar, Murcia, 30150, Spain

Location

Complejo Hospitalario de Navarra

Pamplona, Navarre, 31008, Spain

Location

Hospital de Cabueñes

Gijón, Principality of Asturias, 33394, Spain

Location

Complejo Hospitalario Universitario de Albacete

Albacete, 02008, Spain

Location

Hospital General Universitario de Alicante

Alicante, 03010, Spain

Location

Hospital Universitario Infanta Cristina

Badajoz, 06080, Spain

Location

Hospital del Mar

Barcelona, 08003, Spain

Location

Hospital Universitario Bellvitge

Barcelona, 08907, Spain

Location

Hospital de Sant Joan Despi Moisès Broggi (Consorci Sanitari Integral)

Barcelona, 08970, Spain

Location

Hospital Universitario Reina Sofía

Córdoba, 14006, Spain

Location

Hospital Universitario de Guadalajara

Guadalajara, 19002, Spain

Location

Complejo Hospitalario de Jaén

Jaén, 23008, Spain

Location

Complejo Asistencial Universitario de León

León, 24008, Spain

Location

Hospital Universitario Gregorio Marañón

Madrid, 28007, Spain

Location

Fundación Jiménez Díaz

Madrid, 28040, Spain

Location

Hospital Clínico San Carlos

Madrid, 28040, Spain

Location

Hospital Regional Universitario de Málaga

Málaga, 29009, Spain

Location

Hospital Universitario Virgen de la Victoria

Málaga, 29010, Spain

Location

Hospital Universitario Nuestra Señora de la Candelaria

Santa Cruz de Tenerife, 38010, Spain

Location

Hospital Universitario Virgen del Rocío

Seville, 41013, Spain

Location

Hospital Universitario y Politécnico La Fe

Valencia, 46026, Spain

Location

Hospital Clínico Universitario de Valladolid

Valladolid, 47003, Spain

Location

Hospital Clínico Universitario Lozano Blesa

Zaragoza, 50009, Spain

Location

Hospital Universitario Miguel Servet

Zaragoza, 50009, Spain

Location

Related Publications (2)

• 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.

  PMID: 39672082 DERIVED

• 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.

  PMID: 30930133 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus; Hyperphagia; Insulin Resistance

Interventions

Insulin Glargine; Insulin

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperinsulinism

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Proinsulin

Study Officials

• Gabriel Olveira Fuster, PhD

  Hospital Regional de Malaga

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2016
• First Posted: March 11, 2016
• Study Start: July 1, 2016
• Primary Completion: March 31, 2018
• Study Completion: April 4, 2018
• Last Updated: May 24, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will share

Locations

ES (32)