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Glycated Hemoglobin Targets and Glycemic Control in Indonesian Diabetic Patients

10. juli 2018 opdateret af: Anthony Paulo Sunjaya, Faculty of Medicine, Tarumanagara University

Glycated Hemoglobin Targets and Glycemic Control: Link With Lipid, Uric Acid and Kidney Profile in Indonesian Diabetic Patients

This study aims to compare uric acid, lipid, and kidney profile along with management and complications of Indonesian diabetic patients with good and poor glycemic control based on glycated hemoglobin profile.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Adult patients (≥ 18 years of age) with type 2 diabetes which are diagnosed under ICD-10 coding of E-11 were included in this study. The inclusion criteria are patients with primary diagnosis of E11and have visited the clinic at least twice with a complete record of glucose, uric acid, lipid and kidney profile. Participants were grouped into 2 groups - good and poor glycemic control based on their glycated hemoglobin (HbA1c) levels. Good glycemic control is defined according to the American Diabetes Association and the Indonesian Association of Endocrinologists (PERKENI) cut off of HbA1c < 7.0.

Data such as age, sex, ethnic, education, BMI, glucose, uric acid, lipid, and kidney profile as well as comorbidities and type of drug used were collected from the patients' medical records. Comorbid conditions were defined as either concomitant hypertension, dyslipidemia, chronic kidney disease, hyperuricemia, or combinations of them as diagnosed in the medical records. Diabetic complications of interest include macrovascular (heart disease, stroke), microvascular (nephropathy, retinopathy, neuropathy) and a combination of both as well as infection (urinary tract infection, pneumonia). These complications were also based on the medical records. Management modalities included were lifestyle modification, use of oral antidiabetic medications or insulin, or both.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

55

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

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

N/A

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Adult patients (≥ 18 years of age) with type 2 diabetes which are diagnosed under ICD-10 diagnosis of E-11.

Beskrivelse

Inclusion Criteria:

  • Clinical diagnosis of Type 2 Diabetes
  • Must have visited the clinic at least twice, one before and one post-therapy

Exclusion Criteria:

  • Type 1 Diabetes, Gestational Diabetes and other secondary diabetes types
  • Unavailability of HbA1c results - pre and post-therapy
  • Incomplete records of glucose, uric acid, lipid and kidney profile, comorbidities and management.

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: Andet
  • Tidsperspektiver: Tilbagevirkende kraft

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Good glycemic control
Good glycemic control is defined according to the American Diabetes Association and the Indonesian Association of Endocrinologists (PERKENI) cut off of HbA1c < 7.0.
Andet: Ingen indgriben
Ingen indgriben
Poor glycemic control
Poor glycemic control is defined according to the American Diabetes Association and the Indonesian Association of Endocrinologists (PERKENI) cut off of HbA1c >= 7.0.
Andet: Ingen indgriben
Ingen indgriben

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Lipid Profile
Tidsramme: Through study completion, an average of 1 year
Low-density lipoprotein (LDL), high-density lipoprotein (HDL), total cholesterol and triglyceride levels.
Through study completion, an average of 1 year
Kidney Profile
Tidsramme: Through study completion, an average of 1 year
Urea, Creatinine levels and Proteinuria
Through study completion, an average of 1 year
Uric Acid
Tidsramme: Through study completion, an average of 1 year
Uric Acid Levels
Through study completion, an average of 1 year

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Comorbidities
Tidsramme: Through study completion, an average of 1 year
Comorbid conditions were defined as either concomitant hypertension, dyslipidemia, chronic kidney disease, hyperuricemia, or combinations of them. Diabetic complications of interest include macrovascular (heart disease, stroke), microvascular (nephropathy, retinopathy, neuropathy) and a combination of both as well as infection (urinary tract infection, pneumonia).
Through study completion, an average of 1 year
Management
Tidsramme: Through study completion, an average of 1 year
Management modalities included were lifestyle modification, use of oral antidiabetic medications or insulin, or both.
Through study completion, an average of 1 year

Samarbejdspartnere og efterforskere

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

Sponsor

Faculty of Medicine, Tarumanagara University

Samarbejdspartnere

Hermina Podomoro Hospital

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 (Faktiske)

1. januar 2015

Primær færdiggørelse (Faktiske)

1. december 2015

Studieafslutning (Faktiske)

1. juli 2016

Datoer for studieregistrering

Først indsendt

22. juni 2018

Først indsendt, der opfyldte QC-kriterier

6. juli 2018

Først opslået (Faktiske)

9. juli 2018

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

12. juli 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. juli 2018

Sidst verificeret

1. juli 2018

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • APS001

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

Uafklaret

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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Betingelser

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Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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