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Comparison of Glycaemic Fluctuation and Oxidative Stress Between Two Short-term Therapies for Type 2 Diabetes (COGFOST)

19 augusti 2015 uppdaterad av: Longyi Zeng, Third Affiliated Hospital, Sun Yat-Sen University
The purpose of this study is to compare the blood glucose control, glycaemic fluctuation and oxidative stress for Type 2 Diabetes between two therapies, one is glargine combined with oral drugs and the other is continuous subcutaneous insulin injection.

Studieöversikt

Status

Okänd

Betingelser

Intervention / Behandling

Detaljerad beskrivning

This study was a single-center, randomized, controled and prospective trial. Type 2 diabetic patients were randomized into 2 groups (Group A and Group B). Subjects in group A would be treated by using continuous subcutaneous insulin injection with insulin lispro, while subjects in group B would be treated by using glargine with oral drugs (metformin and gliclazide modified release tablets). After achieving the target glucose levels by two different approaches in 3-5 days, maintain the target glucose level for 3-5 days. Then a Medtronic dynamic blood glucose meter would be applied to the subjects for 72 hours. The clinical data, such as demographic information, present history, past history, personal history and so on were collected in the 1st day. In the 2nd day and the last day of the trial, the blood samples of the patient were collected for the Laboratory Measurements: Cr, uric acid, aminotransferase, lipid profiles, white blood cell count, N%, fasting plasma glucose, fasting C-peptide, insulin, HbA1c and standard meal test (0.5h-postprandial and 2h-postprandial blood glucose levels, C peptide and insulin, et al. The parameters of b-cell function and glycemia fluctuation were calculated and then analyzed by spss 13.0.

Studietyp

Interventionell

Inskrivning (Förväntat)

70

Fas

  • Fas 4

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Kina
    • Guangdong
      • Guangzhou City, Guangdong, Kina, 510630
        • Rekrytering
        • Endocrinology department of the Third Affiliated Hospital of Sun Yet-san University
        • Kontakt:
          • Zeng Longyi, Professor
          • Telefonnummer: 0086-020-85252160
          • E-post: zssynfmk@163.com
        • Kontakt:
        • Huvudutredare:
          • Zeng Longyi, Professor
        • Underutredare:
          • lin Shuo, Doctor

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

25 år till 70 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion Criteria:

  1. investigator diagnosed type 2 diabetes( 1999 WHO diagnosis criteria).
  2. diagnosed as type 2 diabetes in the first time without drug therapy, or type 2 diabetes does not accept insulin in the near 3 month and duration is shorter than 10 years
  3. Fasting plasma glucose ( FPG ) ≥11.1mmol/L or glycated haemoglobin (HbA1c )≥9%.
  4. agree to participate the study and sign the informed consent.

Exclusion Criteria:

  1. obvious failure of heart, hepatic, kidney function.
  2. severe acute or chronic complications, associated diseases. or other diseases that should not use oral hypoglycemic drug.
  3. women in pregnancy or planning to get pregnancy.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Aktiv komparator: GROUP A
using continuous subcutaneous insulin injection with insulin lispro, Humalog, initiating with 0.5-0.8 IU/kg.
Läkemedel: insulin lispro
continuous subcutaneous insulin injection( insulin lispro, Humalog) to reduce blood glucose in a certain level
Andra namn:
  • Humalog
Experimentell: GROUP B
using glargine combined with oral drugs: insulin glargine, Lantus( initiating with 0.2 IU/kg) with metformin hydrochloride, Glucophage 500mg bid and gliclazide modified release tablets, Diamicron modified release(MR) tablets 60mg qd.
Läkemedel: Insulin Glargine
long-acting insulin injection with metformin hydrochloride, Glucophage and gliclazide modified release tablets, Diamicron MR to reduce blood glucose in a certain level
Andra namn:
  • Lantus

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
mean amplitude of glycemic excursions( MAGE)
Tidsram: 3-5 days after patients achieving the target glucose levels, From date of randomization, assessed up to 10 days
a Medtronic dynamic blood glucose meter was applied to the patient for 72 hours, and MAGE is calculated according to the data.
3-5 days after patients achieving the target glucose levels, From date of randomization, assessed up to 10 days

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
glycated hemoglobin A1c
Tidsram: From date of randomization until the end of study, assessed up to 15 days
changes of HbA1c before and after the intervention
From date of randomization until the end of study, assessed up to 15 days
glycated albumin
Tidsram: From date of randomization until the end of study, assessed up to 15 days
changes of glycated albumin before and after the intervention
From date of randomization until the end of study, assessed up to 15 days
fasting plasma glucose, postprandial plasma glucose (30min, 120min)
Tidsram: From date of randomization until the end of study, assessed up to 15 days
changes of fasting and postprandial plasma glucose before and after the intervention
From date of randomization until the end of study, assessed up to 15 days
Fasting C-peptide
Tidsram: From date of randomization until the end of study, assessed up to 15 days
changes of Fasting C-peptide before and after the intervention
From date of randomization until the end of study, assessed up to 15 days
Fasting insulin
Tidsram: From date of randomization until the end of study, assessed up to 15 days
changes of Fasting insulin before and after the intervention
From date of randomization until the end of study, assessed up to 15 days
Homa-β
Tidsram: From date of randomization until the end of study, assessed up to 15 days
changes of Homa-β before and after the intervention
From date of randomization until the end of study, assessed up to 15 days
insulin secretion-sensitivity index
Tidsram: From date of randomization until the end of study, assessed up to 15 days
changes of insulin secretion-sensitivity index before and after the intervention
From date of randomization until the end of study, assessed up to 15 days
disposition index
Tidsram: From date of randomization until the end of study, assessed up to 15 days
changes of disposition index before and after the intervention
From date of randomization until the end of study, assessed up to 15 days
standard deviation of glucose level
Tidsram: during three days' CGMS
standard deviation of glucose level
during three days' CGMS
area under curve (AUC) when the glucose level was higher than 7.8mmol/L
Tidsram: during three days' CGMS
AUC when the glucose level was higher than 7.8mmol/L
during three days' CGMS
area under curve (AUC) when the glucose level was lower than 3.9mmol/L
Tidsram: during three days' CGMS
AUC when the glucose level was higher than 3.9mmol/L
during three days' CGMS
thiobarbituric acid reactive substance
Tidsram: From date of randomization until the end of study, assessed up to 15 days
changes of thiobarbituric acid reactive substance before and after the intervention
From date of randomization until the end of study, assessed up to 15 days
the level of blood 8-hydroxy-2-deoxyguanosine(8-OHdG)
Tidsram: From date of randomization until the end of study, assessed up to 15 days
changes of the level of blood 8-OHdG substance before and after the intervention
From date of randomization until the end of study, assessed up to 15 days

Andra resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
the incidence of hypoglycemia
Tidsram: From date of randomization until the end of study, assessed up to 15 days
the incidence of hypoglycemia, defined as blood glucose lower than 3.9mmol/L
From date of randomization until the end of study, assessed up to 15 days
the incidence of severe hypoglycemia
Tidsram: From date of randomization until the end of study, assessed up to 15 days
defined as hypoglycemia which need other people's help or blood glucose lower than 2.8mmol/L
From date of randomization until the end of study, assessed up to 15 days

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Third Affiliated Hospital, Sun Yat-Sen University

Samarbetspartners

Guangdong Provincial Department of Science and Technology

Utredare

  • Huvudutredare: Zeng Longyi, professor, Endocrinology department of the Third Affiliated Hospital of Sun Yet-san University

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 juli 2015

Primärt slutförande (Förväntat)

1 augusti 2016

Avslutad studie (Förväntat)

1 september 2016

Studieregistreringsdatum

Först inskickad

10 augusti 2015

Först inskickad som uppfyllde QC-kriterierna

15 augusti 2015

Första postat (Uppskatta)

18 augusti 2015

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

20 augusti 2015

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

19 augusti 2015

Senast verifierad

1 augusti 2015

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 20130319c

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