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Weight loss, glycemic control, and cardiovascular disease risk factors in response to differential diet composition in a weight loss program in type 2 diabetes: a randomized controlled trial |
Rock CL, Flatt SW, Pakiz B, Taylor KS, Leone AF, Brelje K, Heath DD, Quintana EL, Sherwood NE |
Diabetes Care 2014 Jun;37(6):1573-1580 |
clinical trial |
6/10 [Eligibility criteria: Yes; 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: Yes; 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 test whether a weight loss program promotes greater weight loss, glycemic control, and improved cardiovascular disease risk factors compared with control conditions and whether there is a differential response to higher versus lower carbohydrate intake. RESEARCH DESIGN AND METHODS: This randomized controlled trial at two university medical centers enrolled 227 overweight or obese adults with type 2 diabetes and assigned them to parallel in-person diet and exercise counseling, with prepackaged foods in a planned menu during the initial phase, or to usual care (UC; two weight loss counseling sessions and monthly contacts). RESULTS: Relative weight loss was 7.4% (95% CI 5.7 to 9.2%), 9.0% (7.1 to 10.9%), and 2.5% (1.3 to 3.8%) for the lower fat, lower carbohydrate, and UC groups (p < 0.001 intervention effect). Glycemic control markers and triglyceride levels were lower in the intervention groups compared with UC group at 1 year (fasting glucose 141 (95% CI 133 to 149) versus 159 (144 to 174) mg/dL, p = 0.023; hemoglobin A1c 6.9% (6.6 to 7.1%) versus 7.5% (7.1 to 7.9%) or 52 (49 to 54) versus 58 (54 to 63) mmol/mol, p = 0.001; triglycerides 148 (134 to 163) versus 204 (173 to 234) mg/dL, p < 0.001). The lower versus higher carbohydrate groups maintained lower hemoglobin A1c (6.6% (95% CI 6.3 to 6.8%) versus 7.2% (6.8 to 7.5%) or 49 (45 to 51) versus 55 (51 to 58) mmol/mol) at 1 year (p = 0.008). CONCLUSIONS: The weight loss program resulted in greater weight loss and improved glycemic control in type 2 diabetes.
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