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Completed

NCT Number: NCT02706119

Insulin in Total Parenteral Nutrition

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital Arquitecto Marcide-Naval, Ferrol, A Coruña, Spain

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

Other names: ATC code A10AE0, Lantus®, Abasaglar®

Regular insulin added to TPN bag

Drug

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

Other names: ATC code A10AB01, Actrapid®

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Fundación Pública Andaluza Progreso y Salud

Other

Registry information

Official study title

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

Acronym: INSUPAR

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Mar 11, 2016
Registry last updated
May 24, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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