Cognitive Function and Brain Structure in Persons With Type 2 Diabetes Mellitus After Intensive Lowering of Blood Pressure and Lipid Levels

Journal Article 1 Mention

Jeff D. Williamson•2014

Lenore J. LaunerR. Nick Bryan

Top 5% · 95th percentile

186 citations · Psychiatry and Mental health

Open Access

TLDR

Lowering blood pressure or cholesterol more aggressively in people with type 2 diabetes did not help prevent memory or thinking problems over about three years.

Summary

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1 Study Aim

The study set out to determine if intensive treatment to lower blood pressure (the force of blood against artery walls) and combination therapy with a statin plus a fibrate (medications that lower cholesterol and triglycerides) could slow down or prevent declines in thinking skills and brain size in people with type 2 diabetes mellitus (T2DM). The researchers wanted to see if these treatments would protect the brain from the damage often seen in people with T2DM, who are at higher risk for memory loss and dementia. The study wanted to find out if stronger blood pressure and cholesterol treatments could help people with type 2 diabetes keep their memory and brain health.

2 Study Design

This research was a large, randomized clinical trial conducted at multiple centers in North America. It included 2,977 adults with type 2 diabetes who did not have dementia at the start. Participants were randomly assigned to either an intensive blood pressure goal (systolic blood pressure less than 120 mm Hg) or a standard goal (less than 140 mm Hg), or to receive a fibrate (a cholesterol-lowering drug) or a placebo, all while keeping low-density lipoprotein cholesterol (LDL-C, or 'bad' cholesterol) below 100 mg/dL. Cognitive tests were given at the start, 20 months, and 40 months. A subset of 503 participants also had brain MRI scans at the start and after 40 months to measure changes in total brain volume (TBV). The study randomly assigned people with type 2 diabetes to different blood pressure and cholesterol treatments and checked their memory and brain size over about three years.

3 Findings

The study reveals that after 40 months, there was no significant difference in memory or thinking skills between people who received intensive blood pressure lowering or fibrate therapy and those who received standard treatments. However, those in the intensive blood pressure group showed a greater decrease in total brain volume compared to the standard group. Fibrate therapy did not affect brain volume. The authors argue that, in people with long-standing type 2 diabetes and well-controlled LDL cholesterol, more aggressive blood pressure or cholesterol treatment did not slow cognitive decline. They recommend focusing on prevention and early intervention for diabetes rather than relying on intensive medication strategies to protect brain health. The research found that stronger blood pressure or cholesterol treatments did not help people with type 2 diabetes keep their memory or brain size over three years.

Abstract

IMPORTANCE: Persons with type 2 diabetes mellitus (T2DM) are at increased risk for decline in cognitive function, reduced brain volume, and increased white matter lesions in the brain. Poor control of blood pressure (BP) and lipid levels are risk factors for T2DM-related cognitive decline, but the effect of intensive treatment on brain function and structure is unknown. OBJECTIVE: To examine whether intensive therapy for hypertension and combination therapy with a statin plus a fibrate reduces the risk of decline in cognitive function and total brain volume (TBV) in patients with T2DM. DESIGN, SETTING, AND PARTICIPANTS: A North American multicenter clinical trial including 2977 participants without baseline clinical evidence of cognitive impairment or dementia and with hemoglobin A1c (HbA1c) levels less than 7.5% randomized to a systolic BP goal of less than 120 vs less than 140 mm Hg (n = 1439) or to a fibrate vs placebo in patients with low-density lipoprotein cholesterol levels less than 100 mg/dL (n = 1538). Participants were recruited from August 1, 2003, through October 31, 2005, with the final follow-up visit by June 30, 2009. MAIN OUTCOME MEASURES: Cognition was assessed at baseline and 20 and 40 months. A subset of 503 participants underwent baseline and 40-month brain magnetic resonance imaging to assess for change in TBV and other structural measures of brain health. RESULTS: Baseline mean HbA1c level was 8.3%; mean age, 62 years; and mean duration of T2DM, 10 years. At 40 months, no differences in cognitive function were found in the intensive BP-lowering trial or in the fibrate trial. At 40 months, TBV had declined more in the intensive vs standard BP-lowering group (difference, -4.4 [95% CI, -7.8 to -1.1] cm(3); P = .01). Fibrate therapy had no effect on TBV compared with placebo. CONCLUSIONS AND RELEVANCE: In participants with long-standing T2DM and at high risk for cardiovascular events, intensive BP control and fibrate therapy in the presence of controlled low-density lipoprotein cholesterol levels did not produce a measurable effect on cognitive decline at 40 months of follow-up. Intensive BP control was associated with greater decline in TBV at 40 months relative to standard therapy. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00000620.

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