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CompletedNCT03580226Updated Jul 12, 2018

Glycated Hemoglobin Targets and Glycemic Control in Indonesian Diabetic Patients

An observational study in Diabetes Mellitus, sponsored by Tarumanagara University. Completed. Per ClinicalTrials.gov, last updated 2018-07-12.

Sponsored by Tarumanagara University · Observational

Study type
Observational
Model
Other
Time perspective
Retrospective
Enrollment
55
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Diabetes Mellitus

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Keywords

  • Diabetes mellitus
  • Glycemic control
  • Lipid profile
  • Kidney profile
  • Uric acid
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 55 is below the median of 233 across 2,220 observational studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Tarumanagara University is the lead sponsor of 11 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

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

Exclusion criteria

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.
05

Study design

Observational model
Other
Time perspective
Retrospective
Enrollment
55 participants (actual)
Patient registry
No

Groups and cohorts

  • 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.

    Other: No intervention

  • 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.

    Other: No intervention

Interventions

  • OtherNo intervention

    No intervention

06

What researchers measure

Primary outcomes

  1. Lipid Profile

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

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

  2. Kidney Profile

    Urea, Creatinine levels and Proteinuria

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

  3. Uric Acid

    Uric Acid Levels

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

Other outcomes

  1. Comorbidities

    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).

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

  2. Management

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

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

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 12, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03580226
Lead sponsor
Tarumanagara University
Collaborators
Hermina Podomoro Hospital
Responsible party
Anthony Paulo Sunjaya (Principal Investigator, Tarumanagara University) — Principal investigator
First posted
Jul 9, 2018
Start date
Jan 2015
Primary completion
Dec 2015
Completion
Jul 2016
Last update
Jul 12, 2018

Study contacts

Anthony P Sunjaya
principal investigator · Tarumanagara University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.

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