Use of GDF15 as a Biomarker for Early Diagnosis of DM and Monitoring of Progress of Complications in Asians

NCT04119167 | Unknown

• 1 other identifier: 201900948B0
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

Significant differences in the expression of individual Growth Differentiation Factor 15 (GDF-15) proteins among Taiwanese harboring different mitochondrial genotypes are noted, and their blood serum levels also exhibited associations with diabetes. GDF-15 was originally discovered as an autocrine regulator of macrophage activation and shown to play important roles in fibrosis, malignancy, cardiovascular disease, glycemic control, and obesity. However, the relationship between GDF-15 and pre-diabetes and diabetes in Asian populations has yet to be fully investigated. Besides, any indirect associations between GDF-15 levels and diabetic complications remain unclear. The investigators aim to further investigate the role of GDF-15 levels in the initial diagnosis of diabetes, the monitoring of medication effectiveness and disease progression, and related complications such as diabetic nephropathy and neuropathy. The DNA isolated from the blood samples will be evaluated to determine individual mitochondria haplogroups, including variants located within the coding and control regions of the mitochondrial genome.

Conditions

Diabetes Mellitus, Type 2; Diabetic Polyneuropathy; Diabetic Nephropathies

Keywords

Diabetes Mellitus, Type 2; Diabetic Polyneuropathy; Diabetic Nephropathy; Growth Differentiation Factor 15

Outcome Measures

Primary Outcomes (4)

• Level of GDF15

  Level of serum GDF15 (pg/mL)

  Up to 9 months

• Complication of diabetes

  Neuropathy (the finding of Nerve Conduction Velocity), retinopathy (the finding of non-mydriatic fundoscopy), nephropathy (the level of serum Creatinine and the amount of albuminuria), number of Participants with coronary artery disease, cerebrovascular disease

  Up to 9 months

• Level of glycated hemoglobin (HbA1c)

  glycemic control (%)

  Up to 9 months

• Level of fasting blood sugar

  glycemic control (mg/dL)

  Up to 9 months

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

From the outpatient department of internal medicine at the Chang Gung Memorial Hospital- Kaohsiung Medical Center

You may qualify if:

• adult participants with age \>20, with pre-DM or DM as the study group and participants without hyperglycemia as the control group

You may not qualify if:

• Pregnant woman or who is under breastfeeding
• Who is difficult to understand or sign the informed consent
• With coagulopathy or hematologic disease

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung Memorial Hospital

Kaohsiung City, Taiwan

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetic Neuropathies; Diabetic Nephropathies

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Shao-Wen Weng, MD/PhD

  Assistant Professor of Chang Gung University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wen-Chieh Chen, MD

CONTACT

886-972-833-798; chingjing@cgmh.org.tw

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2019
• First Posted: October 8, 2019
• Study Start: August 1, 2019
• Primary Completion: July 30, 2021
• Study Completion: October 30, 2021
• Last Updated: October 8, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)