NCT02885922

Brief 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
6,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

August 26, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 1, 2016

Completed
Same day until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
8.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

January 7, 2020

Status Verified

December 1, 2019

Enrollment Period

8.3 years

First QC Date

August 26, 2016

Last Update Submit

January 4, 2020

Conditions

Hyperglycemia

Outcome Measures

Primary Outcomes (1)

  • HbA1c

    3 months

Secondary Outcomes (7)

  • Brain-Derived Neurotrophic Factor (BDNF)

    3 months

  • Body-composition

    3 months

  • Fasting glucose

    3 months

  • Hypoglycemia

    3 months

  • Vascular Cell Adhesion Molecule 1 (VCAM-1)

    3 months

  • +2 more secondary outcomes

Interventions

anti-diabetic drugDRUG

Add-on anti-diabetic drug in type 2 diabetic patients

Also known as: Glucose lowering

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Type 2 diabetic patients in Taichung Veterans General Hospital

You may qualify if:

  • Type 2 diabetic outpatient

You may not qualify if:

  • Refusal of anti-diabetic drugs
  • Preganacy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

outpatient clinic of the Division of Endocrinology and Metabolism in Taichung Veterans General Hospital

Taichung, 407, Taiwan

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

The genetic studies will be applied for efficacy and adverse effect of anti-diabetic drugs.

MeSH Terms

Conditions

Hyperglycemia

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • I-Te Lee, MD,PhD

    Taichung Veterans General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

I-Te Lee, MD,PhD

CONTACT

+886-4-23592525itlee@vghtc.gov.tw

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 26, 2016

First Posted

September 1, 2016

Study Start

September 1, 2016

Primary Completion

December 1, 2024

Study Completion

December 1, 2024

Last Updated

January 7, 2020

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

No plan to make individual participant data (IPD) available

Locations

TW(1)