Diabetes Mellitus, Type 2NCT00364767
Moderate Alcohol Consumption, Fat and Carbohydrate Metabolism and Insulin Sensitivity
A study testing A and B in people with Diabetes Mellitus, Type 2 and Cardiovascular Disease, run by TNO.
Trial summary
Moderate alcohol consumption is associated with a decreased risk of diabetes type 2. This association could be mediated by an improvement of insulin sensitivity with moderate alcohol consumption. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2, Cardiovascular Disease
- What is being tested?
- A and B
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- No sites listed yet
- Study dates
- Oct 2004to Dec 2004
- 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 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy men aged between 18 and 40 years
- Lean subjects BMI 18.5-25 kg/m2 and overweight/obese subjects BMI >27 kg/m2 (including 18.5, 25 and 27)
- Alcohol consumption between 7 and 28 units/week (including 7 and 28)
Who cannot join
- Smoking
- Family history of alcoholism
- History of medical or surgical events that may significantly affect the study outcome, particularly metabolic or endocrine disorders and gastrointestinal disorders
- Recent blood donation
- More than 8 hours/week of intense exercise
- Blood haemoglobin concentration below 8.4 mmol/l
- Allergic to betadine or lidocaine.
About this study
Official title: The Effect of Moderate Alcohol Consumption on Markers of Oxidative Phosphorylation and Lipid Oxidation and on Postprandial Glycemic Control in Healthy, Lean and Overweight, Young Men
Moderate alcohol consumption is associated with a decreased risk of diabetes type 2. This association could be mediated by an improvement of insulin sensitivity with moderate alcohol consumption. Patients with diabetes type 2 or impaired glucose tolerance often may have decreased fat oxidative capacity or oxidative phosphorylation in tissue such as muscle. This could lead to accumulation triglyceride storage in muscle, which could interfere with insulin signaling. Whether such mechanism can also play a role with moderate alcohol consumption is unknown and will be investigated in this study.
In addition, moderate alcohol consumption with a meal can lead to delayed hypoglycemia in type 1 diabetes patients. How moderate alcohol consumption affects postprandial glycemic response in healthy subjects is unknown. This is a secondary objective of this trial.
Read the detailed description
To investigate the effect of moderate alcohol consumption on
- enzymes involved in fatty acid oxidation, oxidative phosphorylation and glycolysis in skeletal muscle
- transporters of fatty acids and glucose in fat tissue
- post-prandial glycemic response in healthy, lean or overweight, young men
Design : Open, randomized, partially diet-controlled, placebo controlled cross-over design
Participants
- Description : Healthy, lean and overweight young (18-40 years) men
- Number : 20
Study substances
- Test substance : 100 ml whiskey (Famous Grouse, 40% v/v alcohol: ≈ 32 g alcohol)
- Reference substance : 100 ml mineral water (Spa blauw)
Duration: 2 treatment periods of 4 weeks (28 days)
Test parameters:
- Muscle biopsy for activity of 3-hydroxy fatty-acyl CoA dehydrogenase, citrate synthase, cytochrome c oxidase
- Postprandial glycemic response (glucose, insulin, GLP-1, GLP-2, GIP, glucagon, FFA etc.)
- Insulin sensitivity and related factors (oral glucose tolerance test, adiponectin, HbA1c)
- Liver enzymes (safety)
- Body weight
- Urinary ethyl glucuronide (compliance)
- Conditions
- Diabetes Mellitus, Type 2, Cardiovascular Disease
- Being tested
- A, B
- Keywords
- Moderate alcohol consumption, Fat and carbohydrate oxidative capacity, Postprandial glycemic response
- Medical subject headings
- Diabetes Mellitus, Type 2, Cardiovascular Diseases, Platelet Glycoprotein IV Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADietary supplement
Alcohol consumption (32 g/day) for 4 weeks
BDietary supplement
Water
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Whiskey (32 gram of alcohol/day) Receives: Dietary Supplement: A |
| B | Placebo comparator | Water (0 gram alcohol/day) Receives: Dietary Supplement: B |
What is being measured
The primary outcome is the main question the study is designed to answer.
enzymes involved in fatty acid oxidation, oxidative phosphorylation and glycolysis in skeletal muscle
Measured: 4 weeks
Secondary outcomes (2)
Post-prandial glycemic response
Measured: 4 weeks
insulin sensitivity (oral glucose tolerance test) and related factors (adiponectin, HbA1c)
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2006 (estimated)
- Study startOct 2004
- Primary completionDec 2004
- Study completionDec 2004
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 Diabetes Mellitus, Type 2Studies 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- TNO
- Sponsor type
- University, hospital or other
- Collaborators
- Dutch Foundation for alcohol research
- Investigators
- Henk FJ Hendriks, PhD., Principal investigator, TNO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00364767
- Sponsor's protocol ID
- P5805
- Status last verified
- May 2008
- First submitted
- 15 Aug 2006
- Last updated
- 23 May 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Beulens JW, van Loon LJ, Kok FJ, Pelsers M, Bobbert T, Spranger J, Helander A, Hendriks HF. The effect of moderate alcohol consumption on adiponectin oligomers and muscle oxidative capacity: a human intervention study. Diabetologia. 2007 Jul;50(7):1388-92. doi: 10.1007/s00125-007-0699-8. Epub 2007 May 11.
PubMed 17492425
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Moderate Alcohol Consumption on Markers of Oxidative Phosphorylation and Lipid Oxidation and on Postprandial Glycemic Control in Healthy, Lean and Overweight, Young Men
- ClinicalTrials.gov ID
- NCT00364767
- Acronym / sponsor ID
- P5805
- Conditions
- Diabetes Mellitus, Type 2, Cardiovascular Disease
- Keywords
- Moderate alcohol consumption, Fat and carbohydrate oxidative capacity, Postprandial glycemic response
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- TNOUniversity, hospital or other
- Collaborators
- Dutch Foundation for alcohol research
- Study start
- Oct 2004
- Primary completion
- Dec 2004 (actual)
- Study completion
- Dec 2004 (actual)
- First posted
- 16 Aug 2006 (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.
Moderate alcohol consumption is associated with a decreased risk of diabetes type 2. This association could be mediated by an improvement of insulin sensitivity with moderate alcohol consumption. Patients with diabetes type 2 or impaired glucose tolerance often may have decreased fat oxidative capacity or oxidative phosphorylation in tissue such as muscle. This could lead to accumulation triglyceride storage in muscle, which could interfere with insulin signaling. Whether such mechanism can also play a role with moderate alcohol consumption is unknown and will be investigated in this study.
In addition, moderate alcohol consumption with a meal can lead to delayed hypoglycemia in type 1 diabetes patients. How moderate alcohol consumption affects postprandial glycemic response in healthy subjects is unknown. This is a secondary objective of this trial.
Detailed description
To investigate the effect of moderate alcohol consumption on
- enzymes involved in fatty acid oxidation, oxidative phosphorylation and glycolysis in skeletal muscle
- transporters of fatty acids and glucose in fat tissue
- post-prandial glycemic response in healthy, lean or overweight, young men
Design : Open, randomized, partially diet-controlled, placebo controlled cross-over design
Participants
- Description : Healthy, lean and overweight young (18-40 years) men
- Number : 20
Study substances
- Test substance : 100 ml whiskey (Famous Grouse, 40% v/v alcohol: ≈ 32 g alcohol)
- Reference substance : 100 ml mineral water (Spa blauw)
Duration: 2 treatment periods of 4 weeks (28 days)
Test parameters:
- Muscle biopsy for activity of 3-hydroxy fatty-acyl CoA dehydrogenase, citrate synthase, cytochrome c oxidase
- Postprandial glycemic response (glucose, insulin, GLP-1, GLP-2, GIP, glucagon, FFA etc.)
- Insulin sensitivity and related factors (oral glucose tolerance test, adiponectin, HbA1c)
- Liver enzymes (safety)
- Body weight
- Urinary ethyl glucuronide (compliance)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Dietary Supplement: AWhiskey (32 gram of alcohol/day) |
| B | Placebo comparator | Dietary Supplement: BWater (0 gram alcohol/day) |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy men aged between 18 and 40 years
- Lean subjects BMI 18.5-25 kg/m2 and overweight/obese subjects BMI >27 kg/m2 (including 18.5, 25 and 27)
- Alcohol consumption between 7 and 28 units/week (including 7 and 28)
Key exclusion criteria (7 listed)
- Smoking
- Family history of alcoholism
- History of medical or surgical events that may significantly affect the study outcome, particularly metabolic or endocrine disorders and gastrointestinal disorders
- Recent blood donation
- More than 8 hours/week of intense exercise
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 |
|---|---|---|
| AAlcohol consumption (32 g/day) for 4 weeks | Dietary supplement | A |
| BWater | Dietary supplement | B |
Primary outcome
enzymes involved in fatty acid oxidation, oxidative phosphorylation and glycolysis in skeletal muscle
Time frame: 4 weeks
2 secondary outcomes
Post-prandial glycemic response
Time frame: 4 weeks
insulin sensitivity (oral glucose tolerance test) and related factors (adiponectin, HbA1c)
Time frame: 4 weeks
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 23 May 2008.
- Results publication: PubMed 17492425Beulens JW, van Loon LJ, Kok FJ, Pelsers M, Bobbert T, Spranger J, Helander A, Hendriks HF. The effect of moderate alcohol consumption on adiponectin oligomers and muscle oxidative capacity: a human intervention study. Diabetologia. 2007 Jul;50(7):1388-92. doi: 10.1007/s00125-007-0699-8. Epub 2007 May 11.
Related trials for Diabetes Mellitus, Type 2
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
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.
Henk FJ Hendriks, PhD. principal investigator
TNO
Questions about this trial
What is this clinical trial studying?
A study testing A and B in people with Diabetes Mellitus, Type 2 and Cardiovascular Disease, run by TNO.
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 7 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 23 May 2008. 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?
enzymes involved in fatty acid oxidation, oxidative phosphorylation and glycolysis in skeletal muscle (time frame: 4 weeks). 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 NCT00364767, 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 23 May 2008.