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NCT02885922 Clinical Trial

The Effects of add-on Anti-diabetic Drugs in Type 2 Diabetic Patients

Hyperglycemia Clinical Trial

Official title:
The Effects of add-on Anti-diabetic Drugs on Inflammation and Energy Homeostasis in Type 2 Diabetic Patients

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02885922
Other study ID # CG16183A
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 2016
Est. completion date December 2024

Study information
Verified date December 2019
Source Taichung Veterans General Hospital
Contact I-Te Lee, MD,PhD
Phone +886-4-23592525
Email itlee@vghtc.gov.tw
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Recently, there are some new classes of anti-diabetic drugs availible in Taiwan. In this study, we will observe the change in inflammation and energy homeostasis in type 2 diabetic outpatient, who receiving a new anti-diabetic drugs.

Description:

Recently, there are some new classes of anti-diabetic drugs availible in Taiwan. However, the effects of these anti-diabetic drugs should be further evaluated. Specially, the effects on inflammation and energy homeostasis are still not well assessed. In this study, we will observe the change in inflammation and energy homeostasis in type 2 diabetic outpatient, who receiving a new anti-diabetic drugs.

Recruitment information / eligibility
Status Recruiting
Enrollment 6000
Est. completion date December 2024
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility Inclusion Criteria:

- Type 2 diabetic outpatient

Exclusion Criteria:

- Refusal of anti-diabetic drugs

- Preganacy

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• anti-diabetic drug
Add-on anti-diabetic drug in type 2 diabetic patients

Locations
Country Name City State
Taiwan outpatient clinic of the Division of Endocrinology and Metabolism in Taichung Veterans General Hospital Taichung

Sponsors (1)
Lead Sponsor Collaborator
Taichung Veterans General Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome
Type Measure Description Time frame Safety issue
Primary HbA1c 3 months
Secondary Brain-Derived Neurotrophic Factor (BDNF) energy homeostasis 3 months
Secondary Body-composition energy homeostasis 3 months
Secondary Fasting glucose 3 months
Secondary Hypoglycemia 3 months
Secondary Vascular Cell Adhesion Molecule 1 (VCAM-1) inflammation 3 months
Secondary Ankle-Brachial Index (ABI) peripheral artery disease 12 months
Secondary Orexin-A 3 months
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