NCT03580226

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2015

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

June 22, 2018

Completed
17 days until next milestone

First Posted

Study publicly available on registry

July 9, 2018

Completed
Last Updated

July 12, 2018

Status Verified

July 1, 2018

Enrollment Period

11 months

First QC Date

June 22, 2018

Last Update Submit

July 10, 2018

Conditions

Diabetes Mellitus

Keywords

Diabetes mellitusGlycemic controlLipid profileKidney profileUric acid

Outcome Measures

Primary Outcomes (3)

  • Lipid Profile

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

    Through study completion, an average of 1 year

  • Kidney Profile

    Urea, Creatinine levels and Proteinuria

    Through study completion, an average of 1 year

  • Uric Acid

    Uric Acid Levels

    Through study completion, an average of 1 year

Other Outcomes (2)

  • Comorbidities

    Through study completion, an average of 1 year

  • Management

    Through study completion, an average of 1 year

Study Arms (2)

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

No interventionOTHER

No intervention

Good glycemic controlPoor glycemic control

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Anthony P Sunjaya

    Tarumanagara University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 22, 2018

First Posted

July 9, 2018

Study Start

January 1, 2015

Primary Completion

December 1, 2015

Study Completion

July 1, 2016

Last Updated

July 12, 2018

Record last verified: 2018-07