ObesityNCT01826279
Short-term Investigation of Resveratrol on Fat Metabolism in Morbidly Obese Women Undergoing Gastric Bypass Surgery
A study testing Resveratrol in people with Obesity, run by University of Aarhus at 1 site in Denmark.
Trial summary
The purpose of this study is to investigate potential metabolic effects of resveratrol in morbidly obese women undergoing gastric bypass surgery. The investigators hypothesize that resveratrol will: Decrease hepatic very-low-density-lipoprotein-triglyceride (VLDL-TG) secretion Decrease hepatic and adipose tissue… Read more about this study
- Who is it for?
- Ages 25 to 60 years, women only
- Conditions the study is for
- Obesity
- What is being tested?
- Resveratrol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteDenmark
- Study dates
- May 2013to Aug 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 25 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female
- 25-60 years
- Obesity (BMI > 35 kg/m2)
- Have at least one element of the metabolic syndrome either hypertension and/or hypercholesterolemia (high triglyceride, low HDL-cholesterol)
- Undergoing gastric bypass surgery
- Written informed consent
Who cannot join
- Any other relevant disease (e.g. diabetes, thyroid or parathyroid disease, heart, kidney or liver disease)
- May have arthrosis or depression
- Any present or previous malignancy
- History of smoking
- Alcohol dependency (more than 14 units of alcohol per week)
- Participation in studies with radioactive isotope within the last six months
- Hemoglobin under the normal range regarding to sex (under 7.3 mmol/l for women)
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Endocrinology and Internal Medicine
Aarhus C, 8000
About this study
Official title: Short-term Investigation of Resveratrol on Lipid Turnover in Morbidly Obese Women Undergoing Gastric Bypass Surgery. Effects on Basal and Insulin Stimulated FFA and VLDL-triglyceride Metabolism and Liver VLDL-triglyceride Uptake.
The purpose of this study is to investigate potential metabolic effects of resveratrol in morbidly obese women undergoing gastric bypass surgery.
The investigators hypothesize that resveratrol will:
Read more
- Decrease hepatic very-low-density-lipoprotein-triglyceride (VLDL-TG) secretion
- Decrease hepatic and adipose tissue VLDL-TG uptake
- Increase insulin sensitivity
The investigators will look at changes in:
- Lipid turnover (VLDL-TG kinetics, palmitate kinetics,calorimetry)
- VLDL-TG uptake in different tissues (subcutaneous femoral adipose tissue, subcutaneous abdominal adipose tissue, visceral adipose tissue and liver tissue)
- Insulin sensitivity (glucose kinetics during hyperinsulinaemic euglycaemic clamp)
- Regulation of liver fat handling
- Lipoprotein lipase activity and fat cell size (abdominal and femoral adipose tissue)
- Conditions
- Obesity
- Being tested
- Resveratrol, Placebo
- Keywords
- Obesity, Gastric bypass surgery, Resveratrol, Insulin sensitivity, Lipid turnover, VLDL-triglyceride uptake, Liver
- Medical subject headings
- Obesity, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ResveratrolDietary supplement
500mg 3 times daily for 1 month
PlaceboOther
1 placebo tablet 3 times daily for 1 month
| Study group | Role | What they receive |
|---|---|---|
| Resveratrol | Experimental | Resveratrol 500mg 3 times daily for 1 month Receives: Dietary Supplement: Resveratrol |
| Placebo | Placebo comparator | Placebo 1 tablet 3 times daily for 1 month Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hepatic VLDL-TG secretion and peripheral VLDL-TG clearance
- changes from baseline after treatment with either resveratrol or placebo
Measured: 1 month
Hepatic and adipose VLDL-TG uptake
- changes in VLDL-TG uptake in resveratrol group and placebo group
Measured: 1 month
Secondary outcomes (3)
Basal and insulin stimulated free fatty acid (FFA) and glucose turnover
- changes from baseline after treatment with either resveratrol or placebo
Measured: 1 month
VLDL-TG oxidation
- changes from baseline after treatment with either resveratrol or placebo
Measured: 1 month
Regulation of liver fat handling
- changes in regulation of liver fat handling in resveratrol group and placebo group
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2013 (estimated)
- Study startMay 2013
- Primary completionAug 2014 (estimated)
- Study completionAug 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of AarhusThe 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- The Ministry of Science, Technology and Innovation, Denmark
- Responsible party
- Sponsor
- Investigators
- Søren Nielsen, MD, associate professor, DMSc, Study chair, Department of Endocrinology and Internal Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01826279
- Sponsor's protocol ID
- M-20110172B
- Status last verified
- May 2013
- First submitted
- 3 Apr 2013
- Last updated
- 30 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-term Investigation of Resveratrol on Lipid Turnover in Morbidly Obese Women Undergoing Gastric Bypass Surgery. Effects on Basal and Insulin Stimulated FFA and VLDL-triglyceride Metabolism and Liver VLDL-triglyceride Uptake.
- ClinicalTrials.gov ID
- NCT01826279
- Acronym / sponsor ID
- M-20110172B
- Conditions
- Obesity
- Keywords
- Obesity, Gastric bypass surgery, Resveratrol, Insulin sensitivity, Lipid turnover, VLDL-triglyceride uptake, Liver
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- The Ministry of Science, Technology and Innovation, Denmark
- Study start
- May 2013
- Primary completion
- Aug 2014 (estimated)
- Study completion
- Aug 2014 (estimated)
- First posted
- 8 Apr 2013 (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.
The purpose of this study is to investigate potential metabolic effects of resveratrol in morbidly obese women undergoing gastric bypass surgery.
The investigators hypothesize that resveratrol will:
- Decrease hepatic very-low-density-lipoprotein-triglyceride (VLDL-TG) secretion
- Decrease hepatic and adipose tissue VLDL-TG uptake
- Increase insulin sensitivity
The investigators will look at changes in:
- Lipid turnover (VLDL-TG kinetics, palmitate kinetics,calorimetry)
- VLDL-TG uptake in different tissues (subcutaneous femoral adipose tissue, subcutaneous abdominal adipose tissue, visceral adipose tissue and liver tissue)
- Insulin sensitivity (glucose kinetics during hyperinsulinaemic euglycaemic clamp)
- Regulation of liver fat handling
- Lipoprotein lipase activity and fat cell size (abdominal and femoral adipose tissue)
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resveratrol | Experimental | Dietary Supplement: ResveratrolResveratrol 500mg 3 times daily for 1 month |
| Placebo | Placebo comparator | Other: PlaceboPlacebo 1 tablet 3 times daily for 1 month |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Female
- 25-60 years
- Obesity (BMI > 35 kg/m2)
- Have at least one element of the metabolic syndrome either hypertension and/or hypercholesterolemia (high triglyceride, low HDL-cholesterol)
- Undergoing gastric bypass surgery
Key exclusion criteria (7 listed)
- Any other relevant disease (e.g. diabetes, thyroid or parathyroid disease, heart, kidney or liver disease)
- May have arthrosis or depression
- Any present or previous malignancy
- History of smoking
- Alcohol dependency (more than 14 units of alcohol per week)
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 |
|---|---|---|
| Resveratrol500mg 3 times daily for 1 month | Dietary supplement | Resveratrol |
| Placebo1 placebo tablet 3 times daily for 1 month | Other | Placebo |
Primary outcome
Hepatic VLDL-TG secretion and peripheral VLDL-TG clearance
Time frame: 1 month
- changes from baseline after treatment with either resveratrol or placebo
Hepatic and adipose VLDL-TG uptake
Time frame: 1 month
- changes in VLDL-TG uptake in resveratrol group and placebo group
3 secondary outcomes
Basal and insulin stimulated free fatty acid (FFA) and glucose turnover
Time frame: 1 month
VLDL-TG oxidation
Time frame: 1 month
Regulation of liver fat handling
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2014.
- Official web page for the LIRMOI project, back ground info and contactLink provided by the sponsor.
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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.
Søren Nielsen, MD, associate professor, DMSc study chair
Department of Endocrinology and Internal Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resveratrol in people with Obesity, run by University of Aarhus at 1 site in Denmark.
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 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: status not confirmed, as of the sponsor's last update on 30 Jan 2014. 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 Denmark. 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. 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?
Results are not available in the source record.
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?
Hepatic VLDL-TG secretion and peripheral VLDL-TG clearance (time frame: 1 month). The study lists 2 primary outcomes in all. 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 30 Jan 2014.