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Completed

NCT Number: NCT03580226

Glycated Hemoglobin Targets and Glycemic Control 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.

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Key information

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No intervention

Other

No intervention

Primary outcomes

  1. Lipid Profile

    Time frame: Through study completion, an average of 1 year

    Low-density lipoprotein (LDL), high-density lipoprotein (HDL), total cholesterol and triglyceride levels.

  2. Kidney Profile

    Time frame: Through study completion, an average of 1 year

    Urea, Creatinine levels and Proteinuria

  3. Uric Acid

    Time frame: Through study completion, an average of 1 year

    Uric Acid Levels

Other outcomes

  1. Comorbidities

    Time frame: 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).

  2. Management

    Time frame: Through study completion, an average of 1 year

    Management modalities included were lifestyle modification, use of oral antidiabetic medications or insulin, or both.

Sponsors and collaborators

Lead sponsor

Tarumanagara University

Other

Collaborators

  • Hermina Podomoro Hospital

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2016
First posted
Jul 9, 2018
Registry last updated
Jul 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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