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To investigate how the visit-to-visit variation in serum lipids measurements affects the decision making concerning treatment according to the National Cholesterol Education Program (NCEP) guidelines in patients with clinically well controlled non-insulin-dependent diabetes mellitus (NIDDM) we have measured the biological variation (CVb) in serum total cholesterol (TC), triglycerides (TG), high density lipoprotein cholesterol (HDL-C) and low density lipoprotein cholesterol (LDL-C) in 26 patients with NIDDM. We found the CVb as follows: TC, 5.1%; TG, 17.0%; HDL-C 4.4% and LDL-C, 8.3%. Confidence intervals (95%) were determined with total intra-individual variance values around the NCEP cut-off points to evaluate how well one, two and three lipid measurements provided reliable risk classification. A single TC measurements &lt; 177 mg/dL or &gt; 263 mg/dL allowed confident classification as "desirable" or "high risk" respectively. For LDL-C, one measurement was accurate only at below 106.3 mg/dL or above 183.7 mg/dL. The average of three measurements contracted these limits to &lt; 186.7 mg/dL and &gt; 253.3 mg/dL for TC, and &lt; 116.3 mg/dL and &gt; 173.7 mg/dL for LDL-C. For HDL-C also, multiple measurements improved risk assignment in a similar fashion. There were no values which allowed assignment to the "borderline high" category with one TC measurement and with one and two LDL-C measurements. The mean of three TC and three LDL-C measurements allowed assignment to the "borderline high" category, if between 213.3 and 226.7 mg/dL for TC, 143.7 and 146.3 mg/dL for LDL-C. Seven patients (26.9%) in this risk group based on the mean of two LDL-C estimates could be placed into a different category when the mean of three estimates was taken, even though the first two LDL-C test results did not differ by more than 30 mg/dL. Our results suggest that repeated lipid measurement is important especially for the "borderline-high" risk group because big variations existed in some patients, and further that TC is the most reliable quantity.

Biological Variation of Serum Lipids and Lipoproteins in Patients with Clinically Well Controlled Non Insulin Dependent Diabetes Mellitus.