Insulin in Total Parenteral Nutrition

Diabetes Mellitus Clinical Trial

— INSUPAR  

Official title:

Subcutaneous Versus Intravenous Basal Insulin in Non-critical Hospitalized Diabetic Patients That Receive Total Parenteral Nutrition

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02706119
• Other study ID #: FPS-INSUPAR-2015-01
• Status: Completed
• Phase: Phase 4
• Start date: July 1, 2016
• Est. completion date: April 4, 2018

Study information

• Verified date: April 2018
• Source: Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 163
• Est. completion date: April 4, 2018
• Est. primary completion date: March 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Spain	Complejo Hospitalario Universitario de Albacete	Albacete
Spain	Hospital Universitario Principe de Asturias	Alcalá de Henares	Madrid
Spain	Hospital General Mancha Centro	Alcázar de San Juan	Ciudad Real
Spain	Hospital General Universitario de Alicante	Alicante
Spain	Hospital Universitario Infanta Cristina	Badajoz
Spain	Hospital de Sant Joan Despi Moisès Broggi (Consorci Sanitari Integral)	Barcelona
Spain	Hospital del Mar	Barcelona
Spain	Hospital Universitario Bellvitge	Barcelona
Spain	Hospital Universitario Reina Sofía	Córdoba
Spain	Hospital Clínico Universitario Virgen de la Arrixaca	El Palmar	Murcia
Spain	Hospital Arquitecto Marcide-Naval	Ferrol	A Coruña
Spain	Hospital Universitario de Fuenlabrada	Fuenlabrada	Madrid
Spain	Hospital de Cabueñes	Gijón	Asturias
Spain	Hospital Universitario de Guadalajara	Guadalajara
Spain	Complejo Hospitalario de Jaén	Jaén
Spain	Hospital Universitario Severo Ochoa	Leganés	Madrid
Spain	Complejo Asistencial Universitario de León	León
Spain	Fundación Jiménez Díaz	Madrid
Spain	Hospital Clínico San Carlos	Madrid
Spain	Hospital Universitario Gregorio Marañón	Madrid
Spain	Hospital Universitario Puerta de Hierro	Majadahonda	Madrid
Spain	Hospital Regional Universitario de Málaga	Málaga
Spain	Hospital Universitario Virgen de la Victoria	Málaga
Spain	Hospital de Mérida	Mérida	Badajoz
Spain	Hospital Son Llátzer	Palma de Mallorca	Baleares
Spain	Complejo Hospitalario de Navarra	Pamplona	Navarra
Spain	Hospital Universitario Virgen del Rocío	Sevilla
Spain	Hospital Universitario Nuestra Señora de la Candelaria	Tenerife
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

Sponsors (1)

Lead Sponsor	Collaborator
Fundación Pública Andaluza Progreso y Salud

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Infections related with catheter used in parenteral nutrition	Investigator asses the occurrence of infectious complications in parenteral nutrition catheter. For the evaluation of the infections, temperature is collected daily and patient will perform a blood test weekly. It will be suspected infectious complication for any sudden onset of fever (usually "peaks"), with no other apparent source of infection.	At day 15 of treatment
Other	Hypertriglyceridemia	A determination above this value will be considered a complication: Hypertriglyceridemia =500 mg/dL	Every 6h during 15 days of treatment.
Other	Hypernatremia	A determination above this value will be considered a complication: Hypernatremia >150 mEq/L	Every 6h during 15 days of treatment.
Other	Hyponatremia	A determination below this value will be considered a complication: Hyponatremia <135 mEq/L	Every 6h during 15 days of treatment.
Other	Hypokalemia	A determination below this value will be considered a complication: Hypokalemia <3 mEq/L	Every 6h during 15 days of treatment.
Other	Hypomagnesemia	A determination below this value will be considered a complication: Hypomagnesemia <1.2 mg/dL	Every 6h during 15 days of treatment.
Other	Hypophosphatemia	A determination below this value will be considered a complication: Hypophosphatemia <2 mg/dL	Every 6h during 15 days of treatment.
Other	Hyperchloremia	A determination above this value will be considered a complication: Hyperchloremia >120 mEq/L	Every 6h during 15 days of treatment.
Other	Hypocalcemia corrected calcium	A determination below this value will be considered a complication: Hypocalcemia corrected calcium <8 mg/dL	Every 6h during 15 days of treatment.
Other	Alteration of liver function markers	Alteration of liver function markers is defined as an elevation twice higher than normal limits, according to each laboratory, of two of some of the following parameters (when previously normal): GGT, GOT, GPT, FA or total bilirubin, at least 7 days after initiating TPN.	At day 7 and 15 of treatment
Other	Adverse events	All adverse events (AEs) are recorded in the case report data since the moment when the patient signs the informed consent. These events will be defined following the organ classification database of MedDRA system.	At day 15 of treatment
Primary	Basal blood glucose value before starting TPN	Basal glucose value before starting TPN (in mg/dL).	Before starting total parenteral nutrition
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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.
Primary	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	Standard deviation of blood glucose	Standard deviation of blood glucose (SD): Expressed in milligrams per deciliter (in mg/dL).	At day 15 of treatment
Secondary	Blood glucose coefficient of variation (CV)	Coefficient of variation (CV): Expressed as a percentage (%). The ratio of the standard deviation of the blood glucoses values (in mg/dL) and the average blood glucose (in mg/dL), multiplied by 100.	At day 15 of treatment