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

January 4, 2020 updated by: Taichung Veterans General Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Anticipated)

6000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • Taichung, Taiwan, 407
        • Recruiting
        • outpatient clinic of the Division of Endocrinology and Metabolism in Taichung Veterans General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Type 2 diabetic patients in Taichung Veterans General Hospital

Description

Inclusion Criteria:

  • Type 2 diabetic outpatient

Exclusion Criteria:

  • Refusal of anti-diabetic drugs
  • Preganacy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
HbA1c
Time Frame: 3 months
3 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taichung Veterans General Hospital

Investigators

  • Principal Investigator: I-Te Lee, MD,PhD, Taichung Veterans General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2016

Primary Completion (Anticipated)

December 1, 2024

Study Completion (Anticipated)

December 1, 2024

Study Registration Dates

First Submitted

August 26, 2016

First Submitted That Met QC Criteria

August 26, 2016

First Posted (Estimate)

September 1, 2016

Study Record Updates

Last Update Posted (Actual)

January 7, 2020

Last Update Submitted That Met QC Criteria

January 4, 2020

Last Verified

December 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CG16183A

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No plan to make individual participant data (IPD) available

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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