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Insulin in Total Parenteral Nutrition (INSUPAR)

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ClinicalTrials.gov Identifier: NCT02706119
Recruitment Status : Completed
First Posted : March 11, 2016
Last Update Posted : May 24, 2018
Sponsor:
Information provided by (Responsible Party):
Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud ( Fundación Pública Andaluza Progreso y Salud )

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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Drug: Subcutaneous glargine insulin Drug: Regular insulin added to TPN bag Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 163 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Subcutaneous Versus Intravenous Basal Insulin in Non-critical Hospitalized Diabetic Patients That Receive Total Parenteral Nutrition
Actual Study Start Date : July 1, 2016
Actual Primary Completion Date : March 31, 2018
Actual Study Completion Date : April 4, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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
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.
Other Names:
  • ATC code A10AE0
  • Lantus®
  • Abasaglar®

Drug: Regular insulin added to TPN bag
Regular insulin is human insulin produced in Saccharomyces cerevisiae by recombinant DNA technology.
Other Names:
  • ATC code A10AB01
  • Actrapid®

Active Comparator: 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
Drug: Regular insulin added to TPN bag
Regular insulin is human insulin produced in Saccharomyces cerevisiae by recombinant DNA technology.
Other Names:
  • ATC code A10AB01
  • Actrapid®




Primary Outcome Measures :
  1. Basal blood glucose value before starting TPN [ Time Frame: Before starting total parenteral nutrition ]
    Basal glucose value before starting TPN (in mg/dL).

  2. Periodical blood glucose [ Time Frame: Every 6h during 15 days of treatment ]
    All blood glucose values (in mg/dL) every 6 hours during 15 days of TPN infusion.

  3. Variation of average blood glucose compared with total dose of insulin [ Time Frame: In days 1, 5 and 15 of treatment ]
    Variation of average glucose (in mg/dL) compared with total dose of insulin (in mL), in days 1, 5 and 15 of treatment.

  4. Number of hypoglycaemia [ Time Frame: During TPN treatment up to 15 days ]
    Number of symptomatic and asymptomatic hypoglycaemia with blood glucose below 70 mg/dL during TPN treatment up to 15 days.

  5. Number of severe hypoglycaemia [ Time Frame: During TPN treatment up to 15 days ]
    Number of symptomatic and asymptomatic hypoglycaemia with blood glucose below 40 mg/dL during TPN treatment up to 15 days.

  6. Hypoglycemia blood glucose values [ Time Frame: Through study completion, an average of 15 days. ]
    If the patient refers typical symptoms of hypoglycemia, a measure of blood glucose (in mg/mL) is immediately taken to check the level

  7. Hypoglycemia symptoms [ Time Frame: Through study completion, an average of 15 days. ]
    If blood glucose <70 mg / dL, it is recorded whether or not the patient has symptoms consistent with hypoglycemia and how the episode terminates


Secondary Outcome Measures :
  1. Standard deviation of blood glucose [ Time Frame: At day 15 of treatment ]
    Standard deviation of blood glucose (SD): Expressed in milligrams per deciliter (in mg/dL).

  2. Blood glucose coefficient of variation (CV) [ Time Frame: At day 15 of treatment ]
    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.


Other Outcome Measures:
  1. Infections related with catheter used in parenteral nutrition [ Time Frame: At day 15 of treatment ]
    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.

  2. Hypertriglyceridemia [ Time Frame: Every 6h during 15 days of treatment. ]
    A determination above this value will be considered a complication: Hypertriglyceridemia ≥500 mg/dL

  3. Hypernatremia [ Time Frame: Every 6h during 15 days of treatment. ]
    A determination above this value will be considered a complication: Hypernatremia >150 mEq/L

  4. Hyponatremia [ Time Frame: Every 6h during 15 days of treatment. ]
    A determination below this value will be considered a complication: Hyponatremia <135 mEq/L

  5. Hypokalemia [ Time Frame: Every 6h during 15 days of treatment. ]
    A determination below this value will be considered a complication: Hypokalemia <3 mEq/L

  6. Hypomagnesemia [ Time Frame: Every 6h during 15 days of treatment. ]
    A determination below this value will be considered a complication: Hypomagnesemia <1.2 mg/dL

  7. Hypophosphatemia [ Time Frame: Every 6h during 15 days of treatment. ]
    A determination below this value will be considered a complication: Hypophosphatemia <2 mg/dL

  8. Hyperchloremia [ Time Frame: Every 6h during 15 days of treatment. ]
    A determination above this value will be considered a complication: Hyperchloremia >120 mEq/L

  9. Hypocalcemia corrected calcium [ Time Frame: Every 6h during 15 days of treatment. ]
    A determination below this value will be considered a complication: Hypocalcemia corrected calcium <8 mg/dL

  10. Alteration of liver function markers [ Time Frame: At day 7 and 15 of treatment ]
    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.

  11. Adverse events [ Time Frame: At day 15 of treatment ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02706119


Locations
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Spain
Hospital Arquitecto Marcide-Naval
Ferrol, A Coruña, Spain, 15405
Hospital de Cabueñes
Gijón, Asturias, Spain, 33394
Hospital de Mérida
Mérida, Badajoz, Spain, 06800
Hospital Son Llátzer
Palma de Mallorca, Baleares, Spain, 07198
Hospital General Mancha Centro
Alcázar de San Juan, Ciudad Real, Spain, 13600
Hospital Universitario Principe de Asturias
Alcalá de Henares, Madrid, Spain, 28805
Hospital Universitario de Fuenlabrada
Fuenlabrada, Madrid, Spain, 28942
Hospital Universitario Severo Ochoa
Leganés, Madrid, Spain, 28911
Hospital Universitario Puerta de Hierro
Majadahonda, Madrid, Spain, 28222
Hospital Clínico Universitario Virgen de la Arrixaca
El Palmar, Murcia, Spain, 30150
Complejo Hospitalario de Navarra
Pamplona, Navarra, Spain, 31008
Complejo Hospitalario Universitario de Albacete
Albacete, Spain, 02008
Hospital General Universitario de Alicante
Alicante, Spain, 03010
Hospital Universitario Infanta Cristina
Badajoz, Spain, 06080
Hospital del Mar
Barcelona, Spain, 08003
Hospital Universitario Bellvitge
Barcelona, Spain, 08907
Hospital de Sant Joan Despi Moisès Broggi (Consorci Sanitari Integral)
Barcelona, Spain, 08970
Hospital Universitario Reina Sofía
Córdoba, Spain, 14006
Hospital Universitario de Guadalajara
Guadalajara, Spain, 19002
Complejo Hospitalario de Jaén
Jaén, Spain, 23008
Complejo Asistencial Universitario de León
León, Spain, 24008
Hospital Universitario Gregorio Marañón
Madrid, Spain, 28007
Fundación Jiménez Díaz
Madrid, Spain, 28040
Hospital Clínico San Carlos
Madrid, Spain, 28040
Hospital Regional Universitario de Málaga
Málaga, Spain, 29009
Hospital Universitario Virgen de la Victoria
Málaga, Spain, 29010
Hospital Universitario Virgen del Rocío
Sevilla, Spain, 41013
Hospital Universitario Nuestra Señora de la Candelaria
Tenerife, Spain, 38010
Hospital Universitario y Politécnico La Fe
Valencia, Spain, 46026
Hospital Clínico Universitario de Valladolid
Valladolid, Spain, 47003
Hospital Clínico Universitario Lozano Blesa
Zaragoza, Spain, 50009
Hospital Universitario Miguel Servet
Zaragoza, Spain, 50009
Sponsors and Collaborators
Fundación Pública Andaluza Progreso y Salud
Investigators
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Principal Investigator: Gabriel Olveira Fuster, PhD Hospital Regional Universitario de Málaga

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Fundación Pública Andaluza Progreso y Salud
ClinicalTrials.gov Identifier: NCT02706119     History of Changes
Other Study ID Numbers: FPS-INSUPAR-2015-01
First Posted: March 11, 2016    Key Record Dates
Last Update Posted: May 24, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud ( Fundación Pública Andaluza Progreso y Salud ):
total parenteral nutrition
glargine insulin
insulin
Additional relevant MeSH terms:
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Insulin
Insulin, Globin Zinc
Insulin Glargine
Hypoglycemic Agents
Physiological Effects of Drugs