HyperglycemiaNCT02885922
The Effects of add-on Anti-diabetic Drugs in Type 2 Diabetic Patients
An observational study of Hyperglycemia, run by Taichung Veterans General Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Hyperglycemia
- What is being tested?
- anti-diabetic drug
- How many people
- 6,000 participants
- Where
- 1 siteTaiwan
- Study dates
- Sep 2016to Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Type 2 diabetic patients in Taichung Veterans General Hospital
Who may be able to join
- Type 2 diabetic outpatient
Who cannot join
- Refusal of anti-diabetic drugs
- Preganacy
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
outpatient clinic of the Division of Endocrinology and Metabolism in Taichung Veterans General Hospital
Taichung, 407
I Te Lee, MD, 886-4-23741340, itlee@vghtc.gov.tw
I Te Lee, MD
About this study
Official title: 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.
Read the 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.
- Conditions
- Hyperglycemia
- Being tested
- anti-diabetic drug
- Medical subject headings
- Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anti-diabetic drugDrug
Also called Glucose lowering
Add-on anti-diabetic drug in type 2 diabetic patients
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
Measured: 3 months
Secondary outcomes (7)
Brain-Derived Neurotrophic Factor (BDNF)
energy homeostasis
Measured: 3 months
Body-composition
energy homeostasis
Measured: 3 months
Fasting glucose
Measured: 3 months
Hypoglycemia
Measured: 3 months
Vascular Cell Adhesion Molecule 1 (VCAM-1)
inflammation
Measured: 3 months
Ankle-Brachial Index (ABI)
peripheral artery disease
Measured: 12 months
Orexin-A
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2016 (estimated)
- Study startSep 2016
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperglycemiaStudies of the same condition, open and under way.
- More trials run by Taichung Veterans General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 6,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taichung Veterans General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- I-Te Lee, MD,PhD, Principal investigator, Taichung Veterans General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02885922
- Sponsor's protocol ID
- CG16183A
- Status last verified
- Dec 2019
- First submitted
- 26 Aug 2016
- Last updated
- 7 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: No plan to make individual participant data (IPD) available
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of add-on Anti-diabetic Drugs on Inflammation and Energy Homeostasis in Type 2 Diabetic Patients
- ClinicalTrials.gov ID
- NCT02885922
- Acronym / sponsor ID
- CG16183A
- Conditions
- Hyperglycemia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 6,000 participants (estimated)
- Lead sponsor
- Taichung Veterans General HospitalUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 1 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Type 2 diabetic patients in Taichung Veterans General Hospital
Key inclusion criteria (1 listed)
- Type 2 diabetic outpatient
Key exclusion criteria (2 listed)
- Refusal of anti-diabetic drugs
- Preganacy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| anti-diabetic drugAlso: Glucose loweringAdd-on anti-diabetic drug in type 2 diabetic patients | Drug | – |
Primary outcome
HbA1c
Time frame: 3 months
7 secondary outcomes
Brain-Derived Neurotrophic Factor (BDNF)
Time frame: 3 months
Body-composition
Time frame: 3 months
Fasting glucose
Time frame: 3 months
Hypoglycemia
Time frame: 3 months
Vascular Cell Adhesion Molecule 1 (VCAM-1)
Time frame: 3 months
Ankle-Brachial Index (ABI)
Time frame: 12 months
Orexin-A
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2020.
- Individual participant dataSharing planned: No. No plan to make individual participant data (IPD) available
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
I-Te Lee, MD,PhD principal investigator
Taichung Veterans General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyperglycemia, run by Taichung Veterans General Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact I-Te Lee, MD,PhD (+886-4-23592525 ext. 4006, itlee@vghtc.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2020.