Insulin ResistanceNCT03348371
The Effects of Ethanol on Intestinal Permeability and Gut Hormones
A study testing Ethanol in people with Insulin Resistance and Ethanol, run by University of Copenhagen.
Trial summary
The aime of this study is to envsitigate if ethanol has an incretin effect. This is done by administration of ethanol orally vs. an isoethanolaemic i.v. infusion of ethanol. Read more about this study
- Who is it for?
- Ages 20 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Insulin Resistance, Ethanol, Incretin Effect
- What is being tested?
- Ethanol
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2016to 1 Oct 2017
- 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 20 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Caucasian male between 20 and 50 years of age
- Body mass index (BMI) between 19 and 25 kg/m2
- Weekly alcohol intake of less than 14 units of alcohol (of 12 g)
- Normal fasting plasma glucose concentration (i.e. <6 mmol/l) and normal glycated haemoglobin A1c (HbA1c) (i.e. ≤42 mmol/mol)
- Normal haemoglobin
- Informed consent
Who cannot join
- First-degree relatives with diabetes and/or liver disease
- Liver disease or other alcohol-related diseases, diabetes mellitus
- Liver disease (serum ALAT and/or serum ASAT >2 × normal values)
- Nephropathy (serum creatinine above normal range and/or albuminuria)
About this study
Official title: The Effects of Orally Ethanol vs. Isoethanolaemic i.v. Infusion of Ethanol on Intestinal Permeability and Gut Hormones
The aime of this study is to envsitigate if ethanol has an incretin effect. This is done by administration of ethanol orally vs. an isoethanolaemic i.v. infusion of ethanol.
- Conditions
- Insulin Resistance, Ethanol, Incretin Effect
- Being tested
- Ethanol
- Keywords
- Incretin effect, Ethanol
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EthanolOther
The intervention is two different administrationforms of ethanol, orally and i.v.
| Study group | Role | What they receive |
|---|---|---|
| Oral day | Experimental | Participant receive ethanol orally Receives: Other: Ethanol |
| i.v. infusion day | Experimental | Participant receive ethanol in an i.v. infusion Receives: Other: Ethanol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum insulin level
difference in serum insulin level between the two administration forms
Measured: 2 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2017
- Study start1 Aug 2016
- Primary completion1 Oct 2017
- Study completion1 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insulin ResistanceStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amalie Lanng, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03348371
- Sponsor's protocol ID
- AlcoGut
- Status last verified
- Nov 2017
- First submitted
- 16 Nov 2017
- Last updated
- 20 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Orally Ethanol vs. Isoethanolaemic i.v. Infusion of Ethanol on Intestinal Permeability and Gut Hormones
- ClinicalTrials.gov ID
- NCT03348371
- Acronym / sponsor ID
- AlcoGut
- Conditions
- Insulin Resistance, Ethanol, Incretin Effect
- Keywords
- Incretin effect, Ethanol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Study start
- 1 Aug 2016 (actual)
- Primary completion
- 1 Oct 2017 (actual)
- Study completion
- 1 Oct 2017 (actual)
- First posted
- 20 Nov 2017 (actual)
- 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.
The aime of this study is to envsitigate if ethanol has an incretin effect. This is done by administration of ethanol orally vs. an isoethanolaemic i.v. infusion of ethanol.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral day | Experimental | Other: EthanolParticipant receive ethanol orally |
| i.v. infusion day | Experimental | Other: EthanolParticipant receive ethanol in an i.v. infusion |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Caucasian male between 20 and 50 years of age
- Body mass index (BMI) between 19 and 25 kg/m2
- Weekly alcohol intake of less than 14 units of alcohol (of 12 g)
- Normal fasting plasma glucose concentration (i.e. <6 mmol/l) and normal glycated haemoglobin A1c (HbA1c) (i.e. ≤42 mmol/mol)
- Normal haemoglobin
Key exclusion criteria (4 listed)
- First-degree relatives with diabetes and/or liver disease
- Liver disease or other alcohol-related diseases, diabetes mellitus
- Liver disease (serum ALAT and/or serum ASAT >2 × normal values)
- Nephropathy (serum creatinine above normal range and/or albuminuria)
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 |
|---|---|---|
| EthanolThe intervention is two different administrationforms of ethanol, orally and i.v. | Other | Oral day, i.v. infusion day |
Primary outcome
Serum insulin level
Time frame: 2 month
difference in serum insulin level between the two administration forms
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 20 Nov 2017.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Ethanol in people with Insulin Resistance and Ethanol, run by University of Copenhagen.
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 6 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: finished, as of the sponsor's last update on 20 Nov 2017. 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. 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?
Serum insulin level (time frame: 2 month). 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 20 Nov 2017.