Clinical trial NCT02706119: Insulin in Total Parenteral Nutrition
Official title: Subcutaneous Versus Intravenous Basal Insulin in Non-critical Hospitalized Diabetic Patients That Receive Total Parenteral Nutrition
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus
Keywords: total parenteral nutrition
glargine insulin
insulin
Lead sponsor: Andalusian Network for Design and Translation of Advanced Therapies
Sponsor class: OTHER
First posted: 2016-03-11
Enrollment: 163
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.

Detailed description: A pattern of basal insulin (using subcutaneous insulin glargine and regulating the stock as prandial), plus regular subcutaneous insulin as rescue, applied to total parenteral nutrition (TPN) should be as effective (glycemic control, variability) and safe (hypoglycemia) as the usual (regular insulin inside the TPN reservoir and subcutaneous insulin as rescue) in patients with type 2 diabetes critics.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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).

Primary outcomes:
measure: Basal blood glucose value before starting TPN
timeFrame: Before starting total parenteral nutrition
measure: Periodical blood glucose
timeFrame: Every 6h during 15 days of treatment
measure: Variation of average blood glucose compared with total dose of insulin
timeFrame: In days 1, 5 and 15 of treatment
measure: Number of hypoglycaemia
timeFrame: During TPN treatment up to 15 days
measure: Number of severe hypoglycaemia
timeFrame: During TPN treatment up to 15 days
measure: Hypoglycemia blood glucose values
timeFrame: Through study completion, an average of 15 days.
measure: Hypoglycemia symptoms
timeFrame: Through study completion, an average of 15 days.
Secondary outcomes:
measure: Standard deviation of blood glucose
timeFrame: At day 15 of treatment
measure: Blood glucose coefficient of variation (CV)
timeFrame: At day 15 of treatment
Other outcomes:
measure: Infections related with catheter used in parenteral nutrition
timeFrame: At day 15 of treatment
measure: Hypertriglyceridemia
timeFrame: Every 6h during 15 days of treatment.
measure: Hypernatremia
timeFrame: Every 6h during 15 days of treatment.
measure: Hyponatremia
timeFrame: Every 6h during 15 days of treatment.
measure: Hypokalemia
timeFrame: Every 6h during 15 days of treatment.
measure: Hypomagnesemia
timeFrame: Every 6h during 15 days of treatment.
measure: Hypophosphatemia
timeFrame: Every 6h during 15 days of treatment.
measure: Hyperchloremia
timeFrame: Every 6h during 15 days of treatment.
measure: Hypocalcemia corrected calcium
timeFrame: Every 6h during 15 days of treatment.
measure: Alteration of liver function markers
timeFrame: At day 7 and 15 of treatment
measure: Adverse events
timeFrame: At day 15 of treatment
Locations:
city: Ferrol
country: Spain
facility: Hospital Arquitecto Marcide-Naval
state: A Coruña
city: Gijón
country: Spain
facility: Hospital de Cabueñes
state: Asturias
city: Mérida
country: Spain
facility: Hospital de Mérida
state: Badajoz
city: Palma de Mallorca
country: Spain
facility: Hospital Son Llátzer
state: Baleares
city: Alcázar de San Juan
country: Spain
facility: Hospital General Mancha Centro
state: Ciudad Real
city: Alcalá de Henares
country: Spain
facility: Hospital Universitario Principe de Asturias
state: Madrid
city: Fuenlabrada
country: Spain
facility: Hospital Universitario de Fuenlabrada
state: Madrid
city: Leganés
country: Spain
facility: Hospital Universitario Severo Ochoa
state: Madrid
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro
state: Madrid
city: El Palmar
country: Spain
facility: Hospital Clínico Universitario Virgen de la Arrixaca
state: Murcia
city: Pamplona
country: Spain
facility: Complejo Hospitalario de Navarra
state: Navarra
city: Albacete
country: Spain
facility: Complejo Hospitalario Universitario de Albacete
city: Alicante
country: Spain
facility: Hospital General Universitario de Alicante
city: Badajoz
country: Spain
facility: Hospital Universitario Infanta Cristina
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Hospital Universitario Bellvitge
city: Barcelona
country: Spain
facility: Hospital de Sant Joan Despi Moisès Broggi (Consorci Sanitari Integral)
city: Córdoba
country: Spain
facility: Hospital Universitario Reina Sofía
city: Guadalajara
country: Spain
facility: Hospital Universitario de Guadalajara
city: Jaén
country: Spain
facility: Complejo Hospitalario de Jaén
city: León
country: Spain
facility: Complejo Asistencial Universitario de León
city: Madrid
country: Spain
facility: Hospital Universitario Gregorio Marañón
city: Madrid
country: Spain
facility: Fundación Jiménez Díaz
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
city: Málaga
country: Spain
facility: Hospital Regional Universitario de Málaga
city: Málaga
country: Spain
facility: Hospital Universitario Virgen de la Victoria
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocío
city: Tenerife
country: Spain
facility: Hospital Universitario Nuestra Señora de la Candelaria
city: Valencia
country: Spain
facility: Hospital Universitario y Politécnico La Fe
city: Valladolid
country: Spain
facility: Hospital Clínico Universitario de Valladolid
city: Zaragoza
country: Spain
facility: Hospital Clínico Universitario Lozano Blesa
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet
Study officials:
affiliation: Hospital Regional de Malaga
name: Gabriel Olveira Fuster, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.