Effect of insulin glargine and n-3FA on carotid intima-media thickness in people with dysglycemia at high risk for cardiovascular events: the glucose reduction and atherosclerosis continuing evaluation study (ORIGIN-GRACE)

What Was Tested

The paper reports a study of Insulin Glargine in the context of atherosclerosis, cardiovascular disease & high blood pressure, published as a randomized controlled trial.

To evaluate the effects of insulin glargine and n-3 polyunsaturated fatty acid (n-3FA) supplements on carotid intima-media thickness (CIMT).

Who Took Part

The study group was 1,184 people.

By PubMed's age tags, the people studied were middle-aged adults and older adults, both men and women.

The researchers enrolled 1,184 people with cardiovascular (CV) disease and/or CV risk factors plus impaired fasting glucose, impaired glucose tolerance, or early type 2 diabetes in a randomized multicenter 2 × 2 factorial design trial.

The primary trial outcome was the annualized rate of change in maximum CIMT for the common carotid, bifurcation, and internal carotid artery segments.

How the Study Was Run

The researchers set it up as a randomized, double-blind, open-label, placebo-controlled and multicenter study.

Random assignment meant chance, not the researchers, decided who got Insulin Glargine and who got the comparison, which limits bias.

Neither the people nor the staff measuring them knew who was on Insulin Glargine, so expectations could not easily colour the readings.

Nothing was hidden in this open-label Insulin Glargine study: the people and staff both knew the treatment.

The comparison arm used a placebo, so changes seen with Insulin Glargine could be set against what happens without it.

Secondary outcomes were the annualized rates of change in maximum CIMT for the common carotid and the common carotid plus bifurcation, respectively.

Baseline followed by annual ultrasounds were obtained during a median follow-up of 4.9 years.

What Was Measured

Topics PubMed links to this paper include Atherosclerosis, Blood Glucose, Carotid Intima-Media Thickness, Fatty Acids, Omega-3, Hypoglycemic Agents, Insulin Glargine and Insulin, Long-Acting.

What This Means in Plain Language

The paper is a randomized, double-blind and open-label study of Insulin Glargine in 1,184 people in people with atherosclerosis, cardiovascular disease & high blood pressure.

With several hundred people or more, it is a fairly large study for this kind of research.

Results are reported in around 3 sentences of the abstract; we leave them to the paper itself rather than summarise them.

The publication is from 2013 (Diabetes care), a journal based in United States.

More context: the Insulin Glargine compound page, Atherosclerosis, cardiovascular disease & high blood pressure research.