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The Look AHEAD Trial: bone loss at 4-year follow-up in type 2 diabetes |
Lipkin EW, Schwartz AV, Anderson AM, Davis C, Johnson KC, Gregg EW, Bray GA, Berkowitz R, Peters AL, Hodges A, Lewis C, Kahn SE, Look AHEAD Research Group |
Diabetes Care 2014 Oct;37(10):2822-2829 |
clinical trial |
5/10 [Eligibility criteria: No; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: Yes; Intention-to-treat analysis: No; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed* |
OBJECTIVE: To determine whether an intensive lifestyle intervention (ILI) designed to sustain weight loss and improve physical fitness in overweight or obese persons with type 2 diabetes was associated with bone loss after 4 years of follow-up. RESEARCH DESIGN AND METHODS: This randomized controlled trial of intensive weight loss compared an ILI with a diabetes support and education (DSE) group among 1,309 overweight or obese subjects. Bone mineral density was assessed at baseline and after 1 year and 4 years of intervention. RESULTS: ILI was effective in producing significant weight loss (5.3% versus 1.8% in ILI and DSE, respectively; p < 0.01) and increased fitness (6.4% versus -0.8%) at year 4. In men, ILI participants had a greater rate of bone loss during the first year (-1.66% versus -0.09% per year in ILI and DSE, respectively). Differences between groups were diminished by one-half after 4 years (-0.88% versus -0.05% per year in ILI and DSE, respectively) but remained significant (p < 0.01). The difference in rate of hip bone loss between groups over 4 years was related to increased weight loss in ILI. Among women, the rate of bone loss did not differ between ILI and DSE after 4 years. CONCLUSIONS: A 4-year weight loss intervention was significantly associated with a modest increase in bone loss at the hip in men but not in women.
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