Glycated Hemoglobin Targets and Glycemic Control in Indonesian Diabetic Patients

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03580226
• Other study ID #: APS001
• Status: Completed
• Start date: January 2015
• Est. completion date: July 2016

Study information

• Verified date: July 2018
• Source: Faculty of Medicine, Tarumanagara University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: July 2016
• Est. primary completion date: December 2015
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Other:
• No intervention
No intervention

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Faculty of Medicine, Tarumanagara University	Hermina Podomoro Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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).	Through study completion, an average of 1 year
Other	Management	Management modalities included were lifestyle modification, use of oral antidiabetic medications or insulin, or both.	Through study completion, an average of 1 year
Primary	Lipid Profile	Low-density lipoprotein (LDL), high-density lipoprotein (HDL), total cholesterol and triglyceride levels.	Through study completion, an average of 1 year
Primary	Kidney Profile	Urea, Creatinine levels and Proteinuria	Through study completion, an average of 1 year
Primary	Uric Acid	Uric Acid Levels	Through study completion, an average of 1 year