Diabetes MellitusNCT00417950
Additional Glucose Lowering and Anti-Inflammatory Effects by Acarbose and Alcohol in Subjects With Impaired Glucose Tolerance or Mild Type 2 Diabetes
A study testing Acarbose in people with Diabetes Mellitus and Impaired Glucose Tolerance, run by Taichung Veterans General Hospital at 1 site in Taiwan.
Trial summary
To understand if acarbose, an alpha-glucosidase inhibitor usually for treating diabetes, will further lower post meal glucose and inflammatory state when taking together with moderate amount of alcohol during meal tolerance test in subjects with impaired glucose tolerance or mild diabetes. Read more about this study
- Who is it for?
- Ages 25 to 75 years
- Conditions the study is for
- Diabetes Mellitus, Impaired Glucose Tolerance
- What is being tested?
- Acarbose
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2007to not given
- Phase
- Interventional
- 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 25 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with mild diabetes without prior medications or impaired glucose tolerance
Who cannot join
- Pregnancy
- Recent major cardiac, renal and hepatic disease
- Intolerance to alcohol
- Allergy to acarbose treatment
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Taichung Veterans General Hospital
Taichung
Wayne H Sheu, MD, PhD, 886-4-23592525 ext. 3068, whhsheu@vghtc.gov.tw
Wayne H Sheu, MD, PhD
About this study
To understand if acarbose, an alpha-glucosidase inhibitor usually for treating diabetes, will further lower post meal glucose and inflammatory state when taking together with moderate amount of alcohol during meal tolerance test in subjects with impaired glucose tolerance or mild diabetes.
- Conditions
- Diabetes Mellitus, Impaired Glucose Tolerance
- Being tested
- Acarbose
- Keywords
- diabetes, acarbose, alcohol, inflammation, oxidative stress, Mild diabetes mellitus
- Medical subject headings
- Diabetes Mellitus, Glucose Intolerance, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcarboseDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Postprandial hyperglycemia
Secondary outcomes (2)
Postprandial inflammatory responses
Postprandial oxidative stress
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2007 (estimated)
- Study startJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- Taichung Veterans General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Tri-Service General Hospital (TSGH)
- Investigators
- Wayne H Sheu, MD, PhD, Principal investigator, Taichung Veterans General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00417950
- Sponsor's protocol ID
- 950801/C06138
- Status last verified
- Jan 2007
- First submitted
- 1 Jan 2007
- Last updated
- 4 Jan 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Additional Glucose Lowering and Anti-Inflammatory Effects by Acarbose and Alcohol in Subjects With Impaired Glucose Tolerance or Mild Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT00417950
- Acronym / sponsor ID
- 950801/C06138
- Conditions
- Diabetes Mellitus, Impaired Glucose Tolerance
- Keywords
- diabetes, acarbose, alcohol, inflammation, oxidative stress, Mild diabetes mellitus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants
- Lead sponsor
- Taichung Veterans General HospitalUniversity, hospital or other
- Collaborators
- Tri-Service General Hospital (TSGH)
- Study start
- Jan 2007
- First posted
- 4 Jan 2007 (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.
To understand if acarbose, an alpha-glucosidase inhibitor usually for treating diabetes, will further lower post meal glucose and inflammatory state when taking together with moderate amount of alcohol during meal tolerance test in subjects with impaired glucose tolerance or mild diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects with mild diabetes without prior medications or impaired glucose tolerance
Key exclusion criteria (4 listed)
- Pregnancy
- Recent major cardiac, renal and hepatic disease
- Intolerance to alcohol
- Allergy to acarbose treatment
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 |
|---|---|---|
| Acarbose | Drug | – |
Primary outcome
Postprandial hyperglycemia
2 secondary outcomes
Postprandial inflammatory responses
Postprandial oxidative stress
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2007.
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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.
Wayne H Sheu, 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?
A study testing Acarbose in people with Diabetes Mellitus and Impaired Glucose Tolerance, 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 4 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 4 Jan 2007. 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, MS (886-4-23592525 ext. 3065, itlee@vghtc.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postprandial hyperglycemia. 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 4 Jan 2007.