N/A
N=78
Effects of Fatty Acid Delivery on Heart Metabolism and Function in Type 2 Diabetes (T2DM
Diabetes Mellitus, Type II
Bottom Line
View on ClinicalTrials.gov: NCT00577590 ↗Enrolled (actual)
78
Serious AEs
0.0%
Results posted
Aug 2018
Primary outcome: Primary: Percent Change in Plasma Triglycerides — -2.0; 16.0; -5.0; -5.0 percent change
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Metformin (Drug); Rosiglitazone (Drug); Lovaza (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Washington University School of Medicine
- Primary completion
- Aug 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change in Plasma Triglycerides |
-2.0; 16.0; -5.0; -5.0; -10.0; 1.0 | — |
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. 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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
- 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
Data sourced from ClinicalTrials.gov (NCT00577590). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.