Effects of ROSIglitazone on Inflammatory Markers and Adipokines in Diabetic Patients Using an Angiotensin Receptor Blocker (TELmisartan) - The ROSITEL Study

• Status: Completed
• Trial end date: 2009-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the ROSITEL study is to assess the effects of rosiglitazone, as compared to standard oral therapies for diabetes (metformin/sulfonylurea), on inflammatory markers and adipokine levels in diabetic patients using an angiotensin receptor blocker (ARB).

We hypothesize that ARB-treated diabetic patients receiving rosiglitazone will experience greater reductions in vascular inflammation and levels of leptin and resistin, associated with increased adiponectin levels, compared to a metformin/sulfonylurea regimen, and that these benefits will result in part, from greater improvements in insulin sensitivity in the rosiglitazone group.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dr. Milan Gupta
• Collaborator: GlaxoSmithKline
• Treatments: Angiotensin Receptor Antagonists; Metformin; Rosiglitazone; Telmisartan

Criteria

Inclusion Criteria:

• Type 2 diabetes

• Hemoglobin A1c (HbA1c) level greater or equal to 0.075

• Treatment naïve (no current oral anti-diabetic therapy) or on monotherapy with either metformin or any sulfonylurea

• Must meet one of the following:

• Already on an angiotensin receptor blocker (ARB for hypertension and/or microalbuminuria OR

• If not on an ARB: SBP>129 mm Hg and/or DBP >79 mm Hg And/Or albumin to creatinine ratio (ACR) > 2.0 mg/mmol in men or > 2.8 mg/mmol in women

Exclusion Criteria:

• Women who are pregnant, breast feeding, or not using a reliable method of contraception

• Clinical signs of congestive heart failure or measured left ventricular ejection fraction <40%

• Hemodynamically significant valvular heart disease or hypertrophic obstructive cardiomyopathy

• Insulin-dependent diabetes mellitus

• Use of any PPAR-ỵ agonist (Rosiglitazone or Pioglitazone)

• Renal dysfunction (creatinine > 1.8 x ULN)

• Hepatic disease (liver function test >1.5 x ULN [upper limit normal])

• Other significant laboratory abnormalities that the investigator feels may compromise the patient's safety by participation in the study

• History of systemic inflammatory disease (rheumatoid arthritis, inflammatory bowel disease, systemic lupus erythematous), myositis/myopathic process, or cancer)

• HIV

• Use of steroids or chemotherapy drugs within the past year or chronic use of nonsteroidal anti-inflammatory drugs besides aspirin (use for > 2 weeks within the past year);

• Patients on potassium sparing-diuretics

• Treatment with excluded medications prior to or at the time of randomization

• Known hypersensitivity to Rosiglitazone, or ARB's

• Participation in another clinical study concurrently or within the 30-day phase prior to screening for entry into the present study

• Unwilling to provide written informed consent for study participant and/or

• Unreliability as a study participant as based on the investigator's prior knowledge of the patient, such as the inability or willingness to participate in or complete the study or the presence of concurrent physical or psychological disorders that may make it impractical for the patient to participate in or complete the study.