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

19. august 2015 opdateret af: 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.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

70

Fase

  • Fase 4

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

25 år til 70 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: GROUP A
using continuous subcutaneous insulin injection with insulin lispro, Humalog, initiating with 0.5-0.8 IU/kg.
Medicin: insulin lispro
continuous subcutaneous insulin injection( insulin lispro, Humalog) to reduce blood glucose in a certain level
Andre navne:
  • Humalog
Eksperimentel: 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.
Medicin: 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
Andre navne:
  • Lantus

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
mean amplitude of glycemic excursions( MAGE)
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
glycated hemoglobin A1c
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: during three days' CGMS
AUC when the glucose level was higher than 3.9mmol/L
during three days' CGMS
thiobarbituric acid reactive substance
Tidsramme: 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)
Tidsramme: 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

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
the incidence of hypoglycemia
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Third Affiliated Hospital, Sun Yat-Sen University

Samarbejdspartnere

Guangdong Provincial Department of Science and Technology

Efterforskere

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

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. juli 2015

Primær færdiggørelse (Forventet)

1. august 2016

Studieafslutning (Forventet)

1. september 2016

Datoer for studieregistrering

Først indsendt

10. august 2015

Først indsendt, der opfyldte QC-kriterier

15. august 2015

Først opslået (Skøn)

18. august 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

20. august 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

19. august 2015

Sidst verificeret

1. august 2015

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 20130319c

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Kliniske forsøg med Diabetes mellitus, type 2

Kliniske forsøg med insulin lispro

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