Ta strona została przetłumaczona automatycznie i dokładność tłumaczenia nie jest gwarantowana. Proszę odnieść się do angielska wersja za tekst źródłowy.

Inpatient Diabetes on Corticosteroids

9 września 2019 zaktualizowane przez: Hennepin Healthcare Research Institute
Despite a significant problem with out-of-control glucose levels in patients with diabetes receiving corticosteroids for a variety of illnesses, there are no published protocols addressing how to adequately treat corticosteroid-induced hyperglycemia. Investigators propose to test a protocol using scheduled dosing of NPH (Neutral protamine Hagedorn) insulin for inpatients with diabetes receiving corticosteroids. NPH insulin action is ideally timed to counteract corticosteroid-induced hyperglycemia, and the dose is added to the patient's usual insulin regimen and timed to correspond to the corticosteroid dosing regimen. Investigators will prospectively enroll eligible consented patients with diabetes who are receiving corticosteroids as part of their treatment in a large county hospital, will randomize them to intervention or control groups, and will monitor their glucose levels during their inpatient stay. The protocol will demonstrate improved control of glucose levels with minimal risk of hypoglycemia, and will provide a practical and readily implementable protocol using NPH insulin as therapy for corticosteroid-induced diabetes.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Szczegółowy opis

As above.

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

85

Faza

  • Faza 4

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Stany Zjednoczone
    • Minnesota
      • Minneapolis, Minnesota, Stany Zjednoczone, 55415
        • Hennepin County Medical Center

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat do 79 lat (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

Inclusion Criteria:

  • Prior history of diabetes
  • Able to provide informed consent
  • Receiving corticosteroids while hospitalized of greater than 10 mg/d prednisone or the equivalent of dexamethasone or methylprednisolone
  • Expect to be hospitalized for 48 hours

Exclusion Criteria:

  • Renal failure with GFR (glomerular filtration rate) < 30 ml/min/1.73m2
  • ALT (alanine aminotransferase) > 2 times upper normal for laboratory

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: NPH with steroid dose

Receive NPH with each corticosteroid dose during the study duration (2-5 days).

Low dose corticosteroids High dose corticosteroids Eating and 6a-8p 0.15 units NPH/kg 0.3 units NPH/kg NPO(nothing by mouth) or 8p-6a 0.1 units NPH/kg 0.2 units NPH/kg
Lek: NPH
NPH given per study table based on steroid dose and patient weight in kg.
Inne nazwy:
  • NPH Lilly Insulin
Lek: Correction Factor
Given at 2 units per 50 mg/dl over 200 mg/dl and increased to 3 units/50 mg/dl over 200 if glucose rises to over 300 mg/dl. Administered qid during study duration.
Inne nazwy:
  • Rapid acting regular insulin
Aktywny komparator: Control - Background and correction insulin
Receive usual care with background insulin and correction factor for duration of study (2-5 days)
Lek: Correction Factor
Given at 2 units per 50 mg/dl over 200 mg/dl and increased to 3 units/50 mg/dl over 200 if glucose rises to over 300 mg/dl. Administered qid during study duration.
Inne nazwy:
  • Rapid acting regular insulin

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Mean POC Glucose Level Between Groups
Ramy czasowe: Assessed from enrollment to discharge or enrollment to day five.
Primary outcome measure was mean blood glucose levels measured pre-meal and at bedtime in study patients and controls for the duration of the intervention. Values shown are the overall mean point of care blood glucose.
Assessed from enrollment to discharge or enrollment to day five.

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Episodes of Hypoglycemia Between NPH and Control Groups
Ramy czasowe: Glucose levels measured pre-meal, at bedtime, and during symptoms of hypoglycemia in study patients and controls for the duration of the intervention. Values shown represent cumulative episodes of hypoglycemia per group.
Hypoglycemia was defined as point of care glucose less than 70 mg/dL.
Glucose levels measured pre-meal, at bedtime, and during symptoms of hypoglycemia in study patients and controls for the duration of the intervention. Values shown represent cumulative episodes of hypoglycemia per group.

Inne miary wyników

Miara wyniku
Opis środka
Ramy czasowe
Percentage of Point of Care Glucose Measurements Between 70 - 180 mg/dL
Ramy czasowe: From day 1 (day of enrollment) to day 5 (last day of study participation) or final day of hospitalization if less than 5 days. Point of care glucose was checked before breakfast, lunch, dinner, bed time and during symptoms of hypoglycemia.
Glucose levels measured pre-meal, at bedtime, and during symptoms of hypoglycemia in study patients and controls for the duration of the intervention. Values shown are the overall percentage of glucose measurements between 70 - 180 mg/dl.
From day 1 (day of enrollment) to day 5 (last day of study participation) or final day of hospitalization if less than 5 days. Point of care glucose was checked before breakfast, lunch, dinner, bed time and during symptoms of hypoglycemia.
Incidence of Hyperglycemia Defined as Point of Care Glucose 180 - 300 mg/dL
Ramy czasowe: From day 1 (day of enrollment) to day 5 (last day of study participation) or final day of hospitalization if less than 5 days. Point of care glucose was checked before breakfast, lunch, dinner, bed time and during symptoms of hypoglycemia.
Glucose levels measured pre-meal, at bedtime, and during symptoms of hypoglycemia in study patients and controls for the duration of the intervention. Values shown are the overall percentage of glucose measurements 180 - 300 mg/dL.
From day 1 (day of enrollment) to day 5 (last day of study participation) or final day of hospitalization if less than 5 days. Point of care glucose was checked before breakfast, lunch, dinner, bed time and during symptoms of hypoglycemia.
Incidence of Hyperglycemia Defined as Point of Care Glucose 300 - 400 mg/dl
Ramy czasowe: From day 1 (day of enrollment) to day 5 (last day of study participation) or final day of hospitalization if less than 5 days. Point of care glucose was checked before breakfast, lunch, dinner, bed time and during symptoms of hypoglycemia.
Glucose levels measured pre-meal, at bedtime, and during symptoms of hypoglycemia in study patients and controls for the duration of the intervention. Values shown are the overall percentage of glucose measurements 300 - 400 mg/dl.
From day 1 (day of enrollment) to day 5 (last day of study participation) or final day of hospitalization if less than 5 days. Point of care glucose was checked before breakfast, lunch, dinner, bed time and during symptoms of hypoglycemia.
Incidence of Hyperglycemia Defined as Point of Care Glucose > 400 mg/dL
Ramy czasowe: From day 1 (day of enrollment) to day 5 (last day of study participation) or final day of hospitalization if less than 5 days. Point of care glucose was checked before breakfast, lunch, dinner, bed time and during symptoms of hypoglycemia.
Glucose levels measured pre-meal, at bedtime, and during symptoms of hypoglycemia in study patients and controls for the duration of the intervention. Values shown are the overall percentage of glucose measurements > 400 mg/dL.
From day 1 (day of enrollment) to day 5 (last day of study participation) or final day of hospitalization if less than 5 days. Point of care glucose was checked before breakfast, lunch, dinner, bed time and during symptoms of hypoglycemia.
Difference in Length of Stay Between NPH and Control Group
Ramy czasowe: Measured from the day of admission till the day of discharge
Time difference of hospitalization between the NPH and control groups.
Measured from the day of admission till the day of discharge
Mean Point of Care (POC) Glucose Level in Both Groups.
Ramy czasowe: On day 1 of study enrollment. Point of care glucose was checked before breakfast, lunch, dinner, and bed time.
The overall mean point of care glucose levels in the NPH group and control group on the first day of the study.
On day 1 of study enrollment. Point of care glucose was checked before breakfast, lunch, dinner, and bed time.
Mean Point of Care (POC) Glucose Level in Both Groups.
Ramy czasowe: On day 5 or last day of hospitalization (if less than 5 days) glucose level as measured by point of care glucose before breakfast, lunch, dinner and bed time.
The overall mean point of care glucose levels in the NPH group and control group on the last day of the study.
On day 5 or last day of hospitalization (if less than 5 days) glucose level as measured by point of care glucose before breakfast, lunch, dinner and bed time.
Correlation of C-peptide With Age
Ramy czasowe: plasma C-peptide was measured once at the time of enrollment
plasma C-peptide was measured once at the time of enrollment
Correlation of C-peptide With BMI
Ramy czasowe: Measured once at the time of enrollment
Measured once at the time of enrollment
Correlation of C-peptide With eGFR
Ramy czasowe: Measured once at the time of enrollment
Measured once at the time of enrollment
Correlation of C-peptide With Serum Creatinine
Ramy czasowe: Measured once at the time of enrollment
Measured once at the time of enrollment
Correlation of C-peptide With ALT
Ramy czasowe: Measured once at the time of enrollment
Measured once at the time of enrollment
Correlation of C-peptide With Hemoglobin A1c
Ramy czasowe: Measured once at the time of enrollment
Measured once at the time of enrollment
Correlation of C-peptide With Duration of Diabetes
Ramy czasowe: Measured once at the time of enrollment
Measured once at the time of enrollment
Correlation of C-peptide With Plasma Glucose
Ramy czasowe: Measured the time of enrollment
Measured the time of enrollment
Correlation of C-peptide With Length of Stay
Ramy czasowe: Measured once at the time of enrollment
Measured once at the time of enrollment

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Hennepin Healthcare Research Institute

Współpracownicy

Eli Lilly and Company

Śledczy

  • Główny śledczy: Lisa Fish, MD, Hennepin County Medical Center, Minneapolis

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów

1 lipca 2014

Zakończenie podstawowe (Rzeczywisty)

1 czerwca 2016

Ukończenie studiów (Rzeczywisty)

1 czerwca 2016

Daty rejestracji na studia

Pierwszy przesłany

4 września 2013

Pierwszy przesłany, który spełnia kryteria kontroli jakości

24 października 2013

Pierwszy wysłany (Oszacować)

28 października 2013

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

1 października 2019

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

9 września 2019

Ostatnia weryfikacja

1 września 2019

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • MMRF-13-3658

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

Badania kliniczne na Cukrzyca

Badania kliniczne na NPH

Wyszukaj podobne próby

Sponsorzy i współpracownicy

Warunki medyczne

Interwencje lekowe

CROs by country

CROs in Vietnam

Warunki

Rzadkie choroby

Interwencje lekowe

Suplementy diety

Sponsor / Współpracownicy

Lokalizacje

Subskrybuj