Diabetes Mellitus, Type IIT2DMNCT00577590
Effects of Fatty Acid Delivery on Heart Metabolism and Function in Type 2 Diabetes (T2DM
A study testing Metformin, Rosiglitazone and Lovaza in people with Diabetes Mellitus, Type II, run by Washington University School of Medicine at 1 site in United States.
Trial summary
Type 2 Diabetes Mellitus (T2DM) is a disease that interferes with the body's proper production and use of insulin, a hormone needed to convert sugar into usable energy. People with Type 2 Diabetes Mellitus (T2DM) are at a higher risk for certain cardiovascular diseases, including heart disease and stroke. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetes Mellitus, Type II
- What is being tested?
- Metformin, Rosiglitazone and Lovaza
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2003to Sep 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meets Americans with Disabilities Act (ADA) criteria for T2DM; if newly diagnosed, must have fasting blood glucose greater than 126 mg/dl on two occasions, a random blood glucose greater than 200 mg/dl with symptoms, or a diagnostic oral glucose tolerance test
- Weight of less than 350 pounds
- Hemoglobin A1c of equal to or less than 7.5% at study entry or willing to go on one of the following therapies to achieve necessary percentage: metformin monotherapy greater than 1000 mg daily for at least 30 days or metformin greater than 1000 mg daily plus any combination of sulfonylurea, glipizide, or alpha-glucosidase inhibitor
- Blood pressure less than 140/90 mm Hg at study entry
- LDL level less than 130 mg/dL if on stable lipid lowering regimen
- Willing to undergo normal rest/stress (treadmill or dobutamine) echocardiogram
- If currently taking thyroid replacement therapy, must be on a stable dose of thyroid replacement and must have a thyroid function blood test that is in the normal range
- Willing to use an effective form of birth control throughout the study
Who cannot join
- Received therapy with an insulin sensitizer of the thiazolidinedione class within 6 months prior to study entry
- Required insulin therapy for more than 2 weeks in the year prior to study entry
- History of angina, heart attack, coronary artery bypass grafting (CABG), stroke, congestive heart failure (CHF), or peripheral vascular disease (PVD)
- Known coronary artery disease (CAD) with residual lesions of greater than 50%
- Current smoker
- Use or expected use of corticosteroids in any form
Show all 10Show fewer
- Serum triglycerides greater than 400 mg/dl on a fasting sample at study entry
- Any contraindication to a thiazolidinedione (TZD) insulin sensitizer, metformin, or other drugs likely to be used during the study
- Liver disease with liver function test (LFT) greater than 2 times the upper limit of normal (ULN)
- Serum creatinine greater than 1.5 mg/dl for women and 1.6 mg/dl for men OR greater than 2+ proteinuria on urine dipstick
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University in St. Louis
St Louis, Missouri, 63110
About this study
Official title: Cyclotron Produced Isotopes in Biology and Medicine, Project 3: Specific Aim 1A and 1B Effects of Fatty Acid Delivery on Myocardial Metabolism and Function in Type 2 Diabetes (T2DM)
Type 2 Diabetes Mellitus (T2DM) is a disease that interferes with the body's proper production and use of insulin, a hormone needed to convert sugar into usable energy. People with Type 2 Diabetes Mellitus (T2DM) are at a higher risk for certain cardiovascular diseases, including heart disease and stroke. Normal treatments for Type 2 Diabetes Mellitus (T2DM) target blood sugar levels only, but there is reason to believe that also targeting blood fat levels will improve both sugar metabolism and heart function in people with Type 2 Diabetes Mellitus, (T2DM.) This study will determine the effectiveness of blood-fat lowering treatments along with blood-sugar control treatments in improving heart function and symptoms of people with Type 2 Diabetes Mellitus(T2DM), and if this varies between men and women.
Read the detailed description
Type 2 Diabetes Mellitus, (T2DM) is the most common type of diabetes. In Type 2 Diabetes Mellitus (T2DM), the body does not properly process sugars and, as a result, there is an excess amount of sugar in the blood. Eventually, the high blood sugar levels can lead to heart disease, nerve damage, kidney problems, or blindness. Typical Type 2 Diabetes Mellitus (T2DM) treatments target maintenance of blood sugar levels. Previous studies on Type 2 Diabetes Mellitus (T2DM) have indicated that in people who have high amounts of fats in the blood, the body relies more heavily on fats than sugars as an energy source. This dependence on fats for energy has been shown to have a negative effect on heart function. There is reason to believe that lowering the levels of fats in the blood will enhance the ability of the heart and the whole body to efficiently use both fats and sugars as energy sources. This study will evaluate the effectiveness of treatment strategies that are designed to reach target levels of sugar and fat in the blood for treating people with Type 2 Diabetes Mellitus (T2DM).
Participation in this double-blind study will last between 4 and 6 months. First, participants will undergo a medical screening and medication adjustment period, expected to last 6 months. The medical screening, lasting about 1 hour, will involve completing a medical history, physical exam, pregnancy test if applicable, and blood test to measure various factors that contribute to diabetes control. Participants will also be asked permission to store 1 tablespoon of their blood for up to 10 years to be used in future studies concerning genetics and heart energy metabolism. During the medication adjustment period, study physicians will adjust the participants' medications, offer advice on diabetes education and nutrition, and record any side effects from the medications. For newly diagnosed Type 2 Diabetes Mellitus (T2DM) participants, the study physician may recommend medication changes to assure a hemoglobin A1c (HgA1c) level of less than 7.5%. If participants have already achieved this level, they will be asked to continue present medications and to also begin taking the medication metformin for the 30 days before they undergo several imaging studies. Next, participants will complete routine tests that evaluate the pumping function of the heart, including an electrocardiogram (ECG) performed before and during exercise, a body composition study using a dual energy x-ray absorptiometry (DEXA) scan, and a magnetic resonance imaging (MRI) test. Each of these tests will last between 30 and 90 minutes.
After the qualifying tests, participants will return for the first of two separate imaging days that will include the same tests. The second imaging day will occur at the end of the medication period, approximately 2 months after the first imaging day. The first tests will be a whole body metabolism study and a heart metabolism imaging study, performed simultaneously. The whole body metabolism study will involve the injection of two tracers of metabolism, one for glucose and one for fatty acids. The heart metabolism imaging study will involve a positron-emission tomographic (PET) scan to take pictures of the heart and will include blood draws. The final imaging test will be a resting echocardiogram (ECHO) to measure heart function.
Following completion of the first day of imaging tests, participants will be randomly assigned to one of three possible treatment groups: Group A ,B, or C. Group A will take Metformin alone.Group B will take Metformin and Rosiglitazone. Group C will take Metformin and Lovaza. Participants will be seen monthly for the next 4 months, during which study medication will be distributed and blood pressure, heart rate, weight, and any side effects, such as lower extremity swelling, will be measured. If there is a noticeable increase in swelling, study physicians may adjust medication dosages. During visits at Months 2 and 4, blood samples will be taken to measure liver and organ function and HgA1c. At the completion of the 4-month medication treatment, participants will undergo repeat imaging tests. If needed, participants will be offered the opportunity to attend one or more follow-up visits to re-establish a medication routine.
- Conditions
- Diabetes Mellitus, Type II
- Being tested
- Metformin, Rosiglitazone, Lovaza
- Keywords
- Type II Diabetes Mellitus, Diabetes, PET, Heart Metabolism, Lovaza
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
Also called Glumetza, Glucophage, Fortamet, Riomet
Metformin is taken alone
RosiglitazoneDrug
Also called Advandia
Rosiglitizone is taken with Metformin
LovazaDrug
Also called Omega-3 acid ethyl esters
Lovaza is taken with Metformin
| Study group | Role | What they receive |
|---|---|---|
| Metformin Alone | Placebo comparator | Participants assigned to take Metformin alone. Receives: Drug: Metformin |
| Metformin and Rosiglitazone | Experimental | Participants assigned to take Metformin and Rosiglitazone Receives: Drug: Metformin; Drug: Rosiglitazone |
| Metformin and Lovaza | Experimental | Participants assigned to take Metformin and Lovaza Receives: Drug: Metformin; Drug: Lovaza |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change in Plasma Triglycerides
Measured: Baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2007 (estimated)
- Study startOct 2003
- Primary completionAug 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type IIStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert Gropler, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00577590
- Sponsor's protocol ID
- 487
- Acronym
- T2DM
- Status last verified
- Aug 2018
- First submitted
- 18 Dec 2007
- Last updated
- 31 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Harris MI, Flegal KM, Cowie CC, Eberhardt MS, Goldstein DE, Little RR, Wiedmeyer HM, Byrd-Holt DD. Prevalence of diabetes, impaired fasting glucose, and impaired glucose tolerance in U.S. adults. The Third National Health and Nutrition Examination Survey, 1988-1994. Diabetes Care. 1998 Apr;21(4):518-24. doi: 10.2337/diacare.21.4.518.
PubMed 9571335Grundy SM, Benjamin IJ, Burke GL, Chait A, Eckel RH, Howard BV, Mitch W, Smith SC Jr, Sowers JR. Diabetes and cardiovascular disease: a statement for healthcare professionals from the American Heart Association. Circulation. 1999 Sep 7;100(10):1134-46. doi: 10.1161/01.cir.100.10.1134. No abstract available.
PubMed 10477542Kannel WB, Hjortland M, Castelli WP. Role of diabetes in congestive heart failure: the Framingham study. Am J Cardiol. 1974 Jul;34(1):29-34. doi: 10.1016/0002-9149(74)90089-7. No abstract available.
PubMed 4835750Koskinen P, Manttari M, Manninen V, Huttunen JK, Heinonen OP, Frick MH. Coronary heart disease incidence in NIDDM patients in the Helsinki Heart Study. Diabetes Care. 1992 Jul;15(7):820-5. doi: 10.2337/diacare.15.7.820.
PubMed 1516498Abbott RD, Donahue RP, Kannel WB, Wilson PW. The impact of diabetes on survival following myocardial infarction in men vs women. The Framingham Study. JAMA. 1988 Dec 16;260(23):3456-60.
PubMed 2974889Peterson LR, Saeed IM, McGill JB, Herrero P, Schechtman KB, Gunawardena R, Recklein CL, Coggan AR, DeMoss AJ, Dence CS, Gropler RJ. Sex and type 2 diabetes: obesity-independent effects on left ventricular substrate metabolism and relaxation in humans. Obesity (Silver Spring). 2012 Apr;20(4):802-10. doi: 10.1038/oby.2011.208. Epub 2011 Aug 4.
PubMed 21818149
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cyclotron Produced Isotopes in Biology and Medicine, Project 3: Specific Aim 1A and 1B Effects of Fatty Acid Delivery on Myocardial Metabolism and Function in Type 2 Diabetes (T2DM)
- ClinicalTrials.gov ID
- NCT00577590
- Acronym / sponsor ID
- T2DM / 487
- Conditions
- Diabetes Mellitus, Type II
- Keywords
- Type II Diabetes Mellitus, Diabetes, PET, Heart Metabolism, Lovaza
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- Oct 2003
- Primary completion
- Aug 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 20 Dec 2007 (estimated)
- Results
- Posted 31 Aug 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Type 2 Diabetes Mellitus (T2DM) is a disease that interferes with the body's proper production and use of insulin, a hormone needed to convert sugar into usable energy. People with Type 2 Diabetes Mellitus (T2DM) are at a higher risk for certain cardiovascular diseases, including heart disease and stroke. Normal treatments for Type 2 Diabetes Mellitus (T2DM) target blood sugar levels only, but there is reason to believe that also targeting blood fat levels will improve both sugar metabolism and heart function in people with Type 2 Diabetes Mellitus, (T2DM.) This study will determine the effectiveness of blood-fat lowering treatments along with blood-sugar control treatments in improving heart function and symptoms of people with Type 2 Diabetes Mellitus(T2DM), and if this varies between men and women.
Detailed description
Type 2 Diabetes Mellitus, (T2DM) is the most common type of diabetes. In Type 2 Diabetes Mellitus (T2DM), the body does not properly process sugars and, as a result, there is an excess amount of sugar in the blood. Eventually, the high blood sugar levels can lead to heart disease, nerve damage, kidney problems, or blindness. Typical Type 2 Diabetes Mellitus (T2DM) treatments target maintenance of blood sugar levels. Previous studies on Type 2 Diabetes Mellitus (T2DM) have indicated that in people who have high amounts of fats in the blood, the body relies more heavily on fats than sugars as an energy source. This dependence on fats for energy has been shown to have a negative effect on heart function. There is reason to believe that lowering the levels of fats in the blood will enhance the ability of the heart and the whole body to efficiently use both fats and sugars as energy sources. This study will evaluate the effectiveness of treatment strategies that are designed to reach target levels of sugar and fat in the blood for treating people with Type 2 Diabetes Mellitus (T2DM).
Participation in this double-blind study will last between 4 and 6 months. First, participants will undergo a medical screening and medication adjustment period, expected to last 6 months. The medical screening, lasting about 1 hour, will involve completing a medical history, physical exam, pregnancy test if applicable, and blood test to measure various factors that contribute to diabetes control. Participants will also be asked permission to store 1 tablespoon of their blood for up to 10 years to be used in future studies concerning genetics and heart energy metabolism. During the medication adjustment period, study physicians will adjust the participants' medications, offer advice on diabetes education and nutrition, and record any side effects from the medications. For newly diagnosed Type 2 Diabetes Mellitus (T2DM) participants, the study physician may recommend medication changes to assure a hemoglobin A1c (HgA1c) level of less than 7.5%. If participants have already achieved this level, they will be asked to continue present medications and to also begin taking the medication metformin for the 30 days before they undergo several imaging studies. Next, participants will complete routine tests that evaluate the pumping function of the heart, including an electrocardiogram (ECG) performed before and during exercise, a body composition study using a dual energy x-ray absorptiometry (DEXA) scan, and a magnetic resonance imaging (MRI) test. Each of these tests will last between 30 and 90 minutes.
After the qualifying tests, participants will return for the first of two separate imaging days that will include the same tests. The second imaging day will occur at the end of the medication period, approximately 2 months after the first imaging day. The first tests will be a whole body metabolism study and a heart metabolism imaging study, performed simultaneously. The whole body metabolism study will involve the injection of two tracers of metabolism, one for glucose and one for fatty acids. The heart metabolism imaging study will involve a positron-emission tomographic (PET) scan to take pictures of the heart and will include blood draws. The final imaging test will be a resting echocardiogram (ECHO) to measure heart function.
Following completion of the first day of imaging tests, participants will be randomly assigned to one of three possible treatment groups: Group A ,B, or C. Group A will take Metformin alone.Group B will take Metformin and Rosiglitazone. Group C will take Metformin and Lovaza. Participants will be seen monthly for the next 4 months, during which study medication will be distributed and blood pressure, heart rate, weight, and any side effects, such as lower extremity swelling, will be measured. If there is a noticeable increase in swelling, study physicians may adjust medication dosages. During visits at Months 2 and 4, blood samples will be taken to measure liver and organ function and HgA1c. At the completion of the 4-month medication treatment, participants will undergo repeat imaging tests. If needed, participants will be offered the opportunity to attend one or more follow-up visits to re-establish a medication routine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Metformin Alone | Placebo comparator | Drug: MetforminParticipants assigned to take Metformin alone. |
| Metformin and Rosiglitazone | Experimental | Drug: Metformin, Drug: RosiglitazoneParticipants assigned to take Metformin and Rosiglitazone |
| Metformin and Lovaza | Experimental | Drug: Metformin, Drug: LovazaParticipants assigned to take Metformin and Lovaza |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Meets Americans with Disabilities Act (ADA) criteria for T2DM; if newly diagnosed, must have fasting blood glucose greater than 126 mg/dl on two occasions, a random blood glucose greater than 200 mg/dl with symptoms, or a diagnostic oral glucose tolerance test
- Weight of less than 350 pounds
- Hemoglobin A1c of equal to or less than 7.5% at study entry or willing to go on one of the following therapies to achieve necessary percentage: metformin monotherapy greater than 1000 mg daily for at least 30 days or metformin greater than 1000 mg daily plus any combination of sulfonylurea, glipizide, or alpha-glucosidase inhibitor
- Blood pressure less than 140/90 mm Hg at study entry
- LDL level less than 130 mg/dL if on stable lipid lowering regimen
Key exclusion criteria (10 listed)
- Received therapy with an insulin sensitizer of the thiazolidinedione class within 6 months prior to study entry
- Required insulin therapy for more than 2 weeks in the year prior to study entry
- History of angina, heart attack, coronary artery bypass grafting (CABG), stroke, congestive heart failure (CHF), or peripheral vascular disease (PVD)
- Known coronary artery disease (CAD) with residual lesions of greater than 50%
- Current smoker
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 |
|---|---|---|
| MetforminAlso: Glumetza, Glucophage, Fortamet, RiometMetformin is taken alone | Drug | Metformin Alone, Metformin and Lovaza, Metformin and Rosiglitazone |
| RosiglitazoneAlso: AdvandiaRosiglitizone is taken with Metformin | Drug | Metformin and Rosiglitazone |
| LovazaAlso: Omega-3 acid ethyl estersLovaza is taken with Metformin | Drug | Metformin and Lovaza |
Primary outcome
Percent Change in Plasma Triglycerides
Time frame: Baseline and 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 9571335Harris MI, Flegal KM, Cowie CC, Eberhardt MS, Goldstein DE, Little RR, Wiedmeyer HM, Byrd-Holt DD. Prevalence of diabetes, impaired fasting glucose, and impaired glucose tolerance in U.S. adults. The Third National Health and Nutrition Examination Survey, 1988-1994. Diabetes Care. 1998 Apr;21(4):518-24. doi: 10.2337/diacare.21.4.518.
- Background: PubMed 10477542Grundy SM, Benjamin IJ, Burke GL, Chait A, Eckel RH, Howard BV, Mitch W, Smith SC Jr, Sowers JR. Diabetes and cardiovascular disease: a statement for healthcare professionals from the American Heart Association. Circulation. 1999 Sep 7;100(10):1134-46. doi: 10.1161/01.cir.100.10.1134. No abstract available.
- Background: PubMed 4835750Kannel WB, Hjortland M, Castelli WP. Role of diabetes in congestive heart failure: the Framingham study. Am J Cardiol. 1974 Jul;34(1):29-34. doi: 10.1016/0002-9149(74)90089-7. No abstract available.
- Background: PubMed 1516498Koskinen P, Manttari M, Manninen V, Huttunen JK, Heinonen OP, Frick MH. Coronary heart disease incidence in NIDDM patients in the Helsinki Heart Study. Diabetes Care. 1992 Jul;15(7):820-5. doi: 10.2337/diacare.15.7.820.
- Background: PubMed 2974889Abbott RD, Donahue RP, Kannel WB, Wilson PW. The impact of diabetes on survival following myocardial infarction in men vs women. The Framingham Study. JAMA. 1988 Dec 16;260(23):3456-60.
- Derived from this study: PubMed 21818149Peterson LR, Saeed IM, McGill JB, Herrero P, Schechtman KB, Gunawardena R, Recklein CL, Coggan AR, DeMoss AJ, Dence CS, Gropler RJ. Sex and type 2 diabetes: obesity-independent effects on left ventricular substrate metabolism and relaxation in humans. Obesity (Silver Spring). 2012 Apr;20(4):802-10. doi: 10.1038/oby.2011.208. Epub 2011 Aug 4.
- Individual participant dataSharing planned: Undecided
Related trials for Diabetes Mellitus, Type II
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.
Robert Gropler, MD principal investigator
Washington University School of 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 Metformin, Rosiglitazone and Lovaza in people with Diabetes Mellitus, Type II, run by Washington University School of Medicine at 1 site in United States.
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 8 inclusion and 10 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 31 Aug 2018. 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 United States. 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?
Yes. Results are posted in the registry (first posted 31 Aug 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percent Change in Plasma Triglycerides (time frame: Baseline and 3 months). 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 NCT00577590, which also lists 6 linked publications.
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 31 Aug 2018.