Effects of Fatty Acid Delivery on Heart Metabolism and Function in Type 2 Diabetes (T2DM

NCT00577590 | Completed Results

• 1 other identifier: 487
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetes Mellitus, Type II

Keywords

Type II Diabetes Mellitus; Diabetes; PET; Heart Metabolism; Lovaza

Outcome Measures

Primary Outcomes (1)

• Percent Change in Plasma Triglycerides

  Baseline and 3 months

Study Arms (3)

Metformin Alone

PLACEBO COMPARATOR

Participants assigned to take Metformin alone.

Drug: Metformin

Metformin and Rosiglitazone

EXPERIMENTAL

Participants assigned to take Metformin and Rosiglitazone

Drug: Metformin; Drug: Rosiglitazone

Metformin and Lovaza

EXPERIMENTAL

Participants assigned to take Metformin and Lovaza

Drug: Metformin; Drug: Lovaza

Interventions

Metformin DRUG

Metformin is taken alone

Also known as: Glumetza, Glucophage, Fortamet, Riomet

Metformin Alone; Metformin and Lovaza; Metformin and Rosiglitazone

Rosiglitazone DRUG

Rosiglitizone is taken with Metformin

Also known as: Advandia

Metformin and Rosiglitazone

Lovaza DRUG

Lovaza is taken with Metformin

Also known as: Omega-3 acid ethyl esters

Metformin and Lovaza

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University in St. Louis

St Louis, Missouri, 63110, United States

Location

Related Publications (6)

• 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.

  PMID: 9571335 BACKGROUND

• Grundy 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.

  PMID: 10477542 BACKGROUND

• Kannel 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.

  PMID: 4835750 BACKGROUND

• Koskinen 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.

  PMID: 1516498 BACKGROUND

• Abbott 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.

  PMID: 2974889 BACKGROUND

• Peterson 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.

  PMID: 21818149 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Interventions

Metformin; Rosiglitazone; Omacor

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Thiazolidinediones; Thiazoles; Sulfur Compounds; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

There were no limitations or caveats

Results Point of Contact

• Title: Robert Gropler, MD, Chief of Cardiovascular Imaging Laboratory
• Organization: Washington University School of Medicine

groplerr@mir.wustl.edu

314-747-3877

Study Officials

• Robert Gropler, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2007
• First Posted: December 20, 2007
• Study Start: October 1, 2003
• Primary Completion: August 1, 2012
• Study Completion: September 1, 2012
• Last Updated: August 31, 2018
• Results First Posted: August 31, 2018

Record last verified: 2018-08

Locations

US (1)