Diabetes Mellitus
Conditions
Keywords
total parenteral nutrition, glargine insulin, insulin
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.
Interventions
DRUGSubcutaneous 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.
DRUGRegular insulin added to TPN bag
Regular insulin is human insulin produced in Saccharomyces cerevisiae by recombinant DNA technology.
Sponsors
Fundación Pública Andaluza Progreso y Salud
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hypoglycemia symptoms | 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 |
| Number of severe hypoglycaemia | 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. |
| Hypoglycemia blood glucose values | 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 |
| Basal blood glucose value before starting TPN | Before starting total parenteral nutrition | Basal glucose value before starting TPN (in mg/dL). |
| Periodical blood glucose | Every 6h during 15 days of treatment | All blood glucose values (in mg/dL) every 6 hours during 15 days of TPN infusion. |
| Variation of average blood glucose compared with total dose of insulin | 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. |
| Number of hypoglycaemia | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood glucose coefficient of variation (CV) | 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. |
| Standard deviation of blood glucose | At day 15 of treatment | Standard deviation of blood glucose (SD): Expressed in milligrams per deciliter (in mg/dL). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Alteration of liver function markers | 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. |
| Infections related with catheter used in parenteral nutrition | 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. |
| Adverse events | 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. |
| Hypertriglyceridemia | Every 6h during 15 days of treatment. | A determination above this value will be considered a complication: Hypertriglyceridemia ≥500 mg/dL |
| Hypernatremia | Every 6h during 15 days of treatment. | A determination above this value will be considered a complication: Hypernatremia \>150 mEq/L |
| Hyponatremia | Every 6h during 15 days of treatment. | A determination below this value will be considered a complication: Hyponatremia \<135 mEq/L |
| Hypokalemia | Every 6h during 15 days of treatment. | A determination below this value will be considered a complication: Hypokalemia \<3 mEq/L |
| Hypomagnesemia | Every 6h during 15 days of treatment. | A determination below this value will be considered a complication: Hypomagnesemia \<1.2 mg/dL |
| Hypophosphatemia | Every 6h during 15 days of treatment. | A determination below this value will be considered a complication: Hypophosphatemia \<2 mg/dL |
| Hyperchloremia | Every 6h during 15 days of treatment. | A determination above this value will be considered a complication: Hyperchloremia \>120 mEq/L |
| Hypocalcemia corrected calcium | Every 6h during 15 days of treatment. | A determination below this value will be considered a complication: Hypocalcemia corrected calcium \<8 mg/dL |
Countries
Spain
Outcome results
None listed