Type 2 DiabetesNCT02309424
The Effect of Vinegar on Glucose and Lipid Metabolism in Subjects With Impaired Glucose Tolerance or Type 2 Diabetes
A study testing Vinegar in people with Type 2 Diabetes, run by Attikon Hospital.
Trial summary
This open, randomized, cross-over, placebo-controlled study aims to investigate the effects of vinegar on glucose metabolism, endothelial function and circulating lipid levels in subjects with impaired glucose tolerance or type 2 diabetes, using the arteriovenous difference technique. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Vinegar
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Jul 2008to Dec 2014
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with impaired glucose tolerance or newly diagnosed type 2 diabetes before the initiation of medication therapy
- Recreationally active
- With stable body weight and diet during the last two months.
Who cannot join
- Any systemic disease (besides glucose abnormalities)
- Any medication therapy
- Diabetic complications
About this study
Official title: The Effect of Vinegar on Glucose and Lipid Metabolism in Peripheral Tissues in Subjects With Impaired Glucose Tolerance or Type 2 Diabetes
This open, randomized, cross-over, placebo-controlled study aims to investigate the effects of vinegar on glucose metabolism, endothelial function and circulating lipid levels in subjects with impaired glucose tolerance or type 2 diabetes, using the arteriovenous difference technique.
Read the detailed description
Subjects with IGT or type 2 diabetes will be randomised to consume 20ml vinegar (6% acetic acid) or placebo before a mixed meal. Plasma samples will be taken for 300min from the radial artery and from a forearm vein for measurements of glucose, insulin, triglycerides, non-esterified fatty acids (NEFA) and glycerol. Muscle blood flow will be measured with strain-gauge plethysmography. Glucose flux will be calculated as the arteriovenous difference of glucose multiplied by the blood flow rates.
- Conditions
- Type 2 Diabetes
- Being tested
- Vinegar, Placebo
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VinegarDietary supplement
0,50mmol vinegar (6% acetic acid)
PlaceboOther
50 ml water
| Study group | Role | What they receive |
|---|---|---|
| Vinegar | Active comparator | 0,50mmol vinegar (6% acetic acid) Receives: Dietary Supplement: Vinegar |
| Placebo | Placebo comparator | 50 ml water Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle glucose uptake following meal ingestion (area under the glucose uptake versus time curve-AUC)
Measured: 0, 30, 60, 90, 120, 180, 240, 300 min postmeal
Secondary outcomes (7)
Plasma glucose levels following meal ingestion (area under the plasma concentration versus time curve-AUC)
Measured: 0, 30, 60, 90, 120, 180, 240, 300 min postmeal
Plasma insulin levels following meal ingestion (area under the plasma concentration versus time curve-AUC)
Measured: 0, 30, 60, 90, 120, 180, 240, 300 min postmeal
Plasma triglyceride levels following meal ingestion (area under the plasma concentration versus time curve-AUC)
Measured: 0, 30, 60, 90, 120, 180, 240, 300 min postmeal
Plasma NEFA levels following meal ingestion (area under the plasma concentration versus time curve-AUC)
Measured: 0, 30, 60, 90, 120, 180, 240, 300 min postmeal
Plasma glycerol levels following meal ingestion (area under the plasma concentration versus time curve-AUC)
Measured: 0, 30, 60, 90, 120, 180, 240, 300 min postmeal
Muscle blood flow following meal ingestion (area under the blood flow rates versus time curve-AUC)
Measured: 0, 30, 60, 90, 120, 180, 240, 300 min postmeal
Number of participants with adverse events
Measured: 300 min postmeal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2014 (estimated)
- Study startJul 2008
- Primary completionDec 2013
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Attikon Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Hellenic National Diabetes Center
- Responsible party
- Principal investigator, Panayota Mitrou, Attikon Hospital
- Investigators
- George D Dimitriadis, Professor, Study director, Attikon Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02309424
- Sponsor's protocol ID
- 167/11-06-08
- Status last verified
- Dec 2014
- First submitted
- 1 Dec 2014
- Last updated
- 5 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Mitrou P, Petsiou E, Papakonstantinou E, Maratou E, Lambadiari V, Dimitriadis P, Spanoudi F, Raptis SA, Dimitriadis G. Vinegar Consumption Increases Insulin-Stimulated Glucose Uptake by the Forearm Muscle in Humans with Type 2 Diabetes. J Diabetes Res. 2015;2015:175204. doi: 10.1155/2015/175204. Epub 2015 May 6.
PubMed 26064976
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Vinegar on Glucose and Lipid Metabolism in Peripheral Tissues in Subjects With Impaired Glucose Tolerance or Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT02309424
- Acronym / sponsor ID
- 167/11-06-08
- Conditions
- Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Attikon HospitalUniversity, hospital or other
- Collaborators
- Hellenic National Diabetes Center
- Study start
- Jul 2008
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 5 Dec 2014 (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.
This open, randomized, cross-over, placebo-controlled study aims to investigate the effects of vinegar on glucose metabolism, endothelial function and circulating lipid levels in subjects with impaired glucose tolerance or type 2 diabetes, using the arteriovenous difference technique.
Detailed description
Subjects with IGT or type 2 diabetes will be randomised to consume 20ml vinegar (6% acetic acid) or placebo before a mixed meal. Plasma samples will be taken for 300min from the radial artery and from a forearm vein for measurements of glucose, insulin, triglycerides, non-esterified fatty acids (NEFA) and glycerol. Muscle blood flow will be measured with strain-gauge plethysmography. Glucose flux will be calculated as the arteriovenous difference of glucose multiplied by the blood flow rates.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vinegar | Active comparator | Dietary Supplement: Vinegar0,50mmol vinegar (6% acetic acid) |
| Placebo | Placebo comparator | Other: Placebo50 ml water |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects with impaired glucose tolerance or newly diagnosed type 2 diabetes before the initiation of medication therapy
- Recreationally active
- With stable body weight and diet during the last two months.
Key exclusion criteria (3 listed)
- Any systemic disease (besides glucose abnormalities)
- Any medication therapy
- Diabetic complications
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 |
|---|---|---|
| Vinegar0,50mmol vinegar (6% acetic acid) | Dietary supplement | Vinegar |
| Placebo50 ml water | Other | Placebo |
Primary outcome
Muscle glucose uptake following meal ingestion (area under the glucose uptake versus time curve-AUC)
Time frame: 0, 30, 60, 90, 120, 180, 240, 300 min postmeal
7 secondary outcomes
Plasma glucose levels following meal ingestion (area under the plasma concentration versus time curve-AUC)
Time frame: 0, 30, 60, 90, 120, 180, 240, 300 min postmeal
Plasma insulin levels following meal ingestion (area under the plasma concentration versus time curve-AUC)
Time frame: 0, 30, 60, 90, 120, 180, 240, 300 min postmeal
Plasma triglyceride levels following meal ingestion (area under the plasma concentration versus time curve-AUC)
Time frame: 0, 30, 60, 90, 120, 180, 240, 300 min postmeal
Plasma NEFA levels following meal ingestion (area under the plasma concentration versus time curve-AUC)
Time frame: 0, 30, 60, 90, 120, 180, 240, 300 min postmeal
Plasma glycerol levels following meal ingestion (area under the plasma concentration versus time curve-AUC)
Time frame: 0, 30, 60, 90, 120, 180, 240, 300 min postmeal
Muscle blood flow following meal ingestion (area under the blood flow rates versus time curve-AUC)
Time frame: 0, 30, 60, 90, 120, 180, 240, 300 min postmeal
Number of participants with adverse events
Time frame: 300 min postmeal
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2014.
- Derived from this study: PubMed 26064976Mitrou P, Petsiou E, Papakonstantinou E, Maratou E, Lambadiari V, Dimitriadis P, Spanoudi F, Raptis SA, Dimitriadis G. Vinegar Consumption Increases Insulin-Stimulated Glucose Uptake by the Forearm Muscle in Humans with Type 2 Diabetes. J Diabetes Res. 2015;2015:175204. doi: 10.1155/2015/175204. Epub 2015 May 6.
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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.
George D Dimitriadis, Professor study director
Attikon Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Vinegar in people with Type 2 Diabetes, run by Attikon Hospital.
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 5 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle glucose uptake following meal ingestion (area under the glucose uptake versus time curve-AUC) (time frame: 0, 30, 60, 90, 120, 180, 240, 300 min postmeal). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02309424, which also lists 1 linked publication.
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 5 Dec 2014; AzTrials last refreshed its copy on 8 Nov 2026.