Thiazolidinedione (TZD) on the Diabetic Retinopathy and Nephropathy
Status:
Unknown status
Trial end date:
2015-12-01
Target enrollment:
Participant gender:
Summary
Objectives:
Thiazolidinediones (TZDs) are insulin sensitizers that decrease plasma glucose in type 2
diabetic patients. Thiazolidinediones can cause fluid retention and peripheral edema in
diabetic patients, and the systematic fluid retention can be manifested as diabetic macular
edema (DME). The overall goal of this study is to examine the effects of thiazolidinediones
on the diabetic retinopathy and nephropathy.
Study design:
This is a prospective, randomized, open-labeled, controlled design to assess the effects
thiozolidinediones on the diabetic retinopathy and nephropathy. The investigators will
recruit 300 type 2 diabetic patients without significant retinopathy, nephropathy and
cardiovascular disease. Inclusion criteria are type 2 diabetes, age between 30-80 years old,
with microabluminuria, no significant retinopathy, on submaximal dose of sulphonylureas and
metformin treatment, and A1C between 7-9%. Exclusion criteria are on insulin treatment,
significant retinopathy and significant nephropathy. Patients with cardiovascular diseases,
malignancy, pregnancy, in acute intercurrent illness, congestive heart failure, myocardial
infarction, received PCI or CABG. All subjects will receive EKG and CXR before randomization.
These subjects will be randomized equally to 3 groups: acarbose, rosiglitazone and
pioglitazone. The investigators will follow up for 6 months to investigate the short-term
effects and 5 years to evaluate the long-term outcomes. The primary study end point of
short-term study will be the macular thickness changes measured by optical coherence
tomography, the changes in the level of urinary albumin-to-creatinine ratio, circulating
metabolic parameters and adipocytokines during thiozolidinediones treatment. Secondary end
point will be fasting blood glucose, A1C levels, development of clinically significant
macular edema, serum creatinine change in patients with no history of diabetic retinopathy
and nephropathy at baseline.
The primary study end point of long-term study will be the development of clinically
significant macular edema and the time from the base-line visit to the first detection of
overt nephropathy. Secondary end points include the development of greater than moderate
NPDR, the time to the first event of the time from the base-line visit to a doubling of the
serum creatinine concentration, end-stage renal disease, or death.