Diabetes MellitusNCT03580226
Glycated Hemoglobin Targets and Glycemic Control in Indonesian Diabetic Patients
An observational study of Diabetes Mellitus, run by Tarumanagara University.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetes Mellitus
- How many people
- 55 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Jul 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Study population: Adult patients (≥ 18 years of age) with type 2 diabetes which are diagnosed under ICD-10 diagnosis of E-11.
Who may be able to join
- Clinical diagnosis of Type 2 Diabetes
- Must have visited the clinic at least twice, one before and one post-therapy
Who cannot join
- 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.
About this study
Official title: 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.
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.
- Conditions
- Diabetes Mellitus
- Being tested
- No intervention
- Keywords
- Diabetes mellitus, Glycemic control, Lipid profile, Kidney profile, Uric acid
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lipid Profile
Low-density lipoprotein (LDL), high-density lipoprotein (HDL), total cholesterol and triglyceride levels.
Measured: Through study completion, an average of 1 year
Kidney Profile
Urea, Creatinine levels and Proteinuria
Measured: Through study completion, an average of 1 year
Uric Acid
Uric Acid Levels
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2018
- Study startJan 2015
- Primary completionDec 2015
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tarumanagara University
- Sponsor type
- University, hospital or other
- Collaborators
- Hermina Podomoro Hospital
- Responsible party
- Principal investigator, Anthony Paulo Sunjaya, Tarumanagara University
- Investigators
- Anthony P Sunjaya, Principal investigator, Tarumanagara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03580226
- Sponsor's protocol ID
- APS001
- Status last verified
- Jul 2018
- First submitted
- 22 Jun 2018
- Last updated
- 12 Jul 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glycated Hemoglobin Targets and Glycemic Control: Link With Lipid, Uric Acid and Kidney Profile in Indonesian Diabetic Patients
- ClinicalTrials.gov ID
- NCT03580226
- Acronym / sponsor ID
- APS001
- Conditions
- Diabetes Mellitus
- Keywords
- Diabetes mellitus, Glycemic control, Lipid profile, Kidney profile, Uric acid
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Tarumanagara UniversityUniversity, hospital or other
- Collaborators
- Hermina Podomoro Hospital
- Study start
- Jan 2015 (actual)
- Primary completion
- Dec 2015 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 9 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Good glycemic control | – | Other: No interventionGood glycemic control is defined according to the American Diabetes Association and the Indonesian Association of Endocrinologists (PERKENI) cut off of HbA1c < 7.0. |
| Poor glycemic control | – | Other: No interventionPoor glycemic control is defined according to the American Diabetes Association and the Indonesian Association of Endocrinologists (PERKENI) cut off of HbA1c >= 7.0. |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Adult patients (≥ 18 years of age) with type 2 diabetes which are diagnosed under ICD-10 diagnosis of E-11.
Key inclusion criteria (2 listed)
- Clinical diagnosis of Type 2 Diabetes
- Must have visited the clinic at least twice, one before and one post-therapy
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | Good glycemic control, Poor glycemic control |
Primary outcome
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.
Kidney Profile
Time frame: Through study completion, an average of 1 year
Urea, Creatinine levels and Proteinuria
Uric Acid
Time frame: Through study completion, an average of 1 year
Uric Acid Levels
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anthony P Sunjaya principal investigator
Tarumanagara University
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, run by Tarumanagara University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lipid Profile (time frame: Through study completion, an average of 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2018.