Lipid and inflammatory cardiovascular risk worsens over 3 years in youth with type 2 diabetes: the TODAY clinical trial

Diabetes Care. 2013 Jun;36(6):1758-64. doi: 10.2337/dc12-2388.

Abstract

Objective: Type 2 diabetes increases cardiovascular risk. We examined lipid profiles and inflammatory markers in 699 youth with recent-onset type 2 diabetes in the TODAY clinical trial and compared changes across treatment groups: metformin alone (M), metformin plus rosiglitazone (M+R), and metformin plus intensive lifestyle program (M+L).

Research design and methods: Multiethnic youth with type 2 diabetes received M, M+R, or M+L. Statin drugs were begun for LDL cholesterol (LDL) ≥ 130 mg/dL or triglycerides ≥ 300 mg/dL. Lipids, apolipoprotein B (apoB), LDL particle size, high-sensitivity c-reactive protein (hsCRP), homocysteine, plasminogen activator inhibitor-1 (PAI-1), and HbA1c were measured over 36 months or until loss of glycemic control.

Results: LDL, apoB, triglycerides, and non-HDL cholesterol (HDL) rose over 12 months and then stabilized over the next 24 months. Participants with LDL ≥ 130 mg/dL or using LDL-lowering therapy increased from 4.5 to 10.7% over 36 months, while 55.9% remained at LDL goal (<100 mg/dL) over that time. Treatment group did not impact LDL, apoB, or non-HDL. Small dense LDL (particle size, ≤ 0.263 relative flotation rate) was most common in M. Triglycerides were lower in M+L than M, and M+L attenuated the negative effect of hyperglycemia on triglycerides and HDL in females. hsCRP, PAI-1, and homocysteine increased over time. However, hsCRP was lower in M+R compared with M or M+L.

Conclusions: Dyslipidemia and chronic inflammation were common in youth with type 2 diabetes and worsened over time. Diabetes treatment, despite some treatment group differences in lipid and inflammatory marker change over time, is generally inadequate to control this worsening risk.

Trial registration: ClinicalTrials.gov NCT00081328.

Publication types

  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Apolipoproteins B / blood
  • C-Reactive Protein / metabolism
  • Cardiovascular Diseases / blood*
  • Child
  • Cholesterol, LDL / blood
  • Diabetes Mellitus, Type 2 / blood*
  • Female
  • Glycated Hemoglobin A / metabolism
  • Humans
  • Inflammation / blood*
  • Lipids / blood*
  • Male
  • Plasminogen Activator Inhibitor 1 / blood

Substances

  • Apolipoproteins B
  • Cholesterol, LDL
  • Glycated Hemoglobin A
  • Lipids
  • Plasminogen Activator Inhibitor 1
  • C-Reactive Protein

Associated data

  • ClinicalTrials.gov/NCT00081328

Grant support