Clinical trial NCT03580226: Glycated Hemoglobin Targets and Glycemic Control in Indonesian Diabetic Patients
Official title: Glycated Hemoglobin Targets and Glycemic Control: Link With Lipid, Uric Acid and Kidney Profile in Indonesian Diabetic Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus
Keywords: Diabetes mellitus
Glycemic control
Lipid profile
Kidney profile
Uric acid
Lead sponsor: Tarumanagara University
Sponsor class: OTHER
Collaborators: name: Hermina Podomoro Hospital
First posted: 2018-07-09
Enrollment: 55
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: RETROSPECTIVE
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.

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Lipid Profile
timeFrame: Through study completion, an average of 1 year
measure: Kidney Profile
timeFrame: Through study completion, an average of 1 year
measure: Uric Acid
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
measure: Comorbidities
timeFrame: Through study completion, an average of 1 year
measure: Management
timeFrame: Through study completion, an average of 1 year
Locations:
Study officials:
affiliation: Tarumanagara University
name: Anthony P Sunjaya
role: PRINCIPAL_INVESTIGATOR
References: