Lifestyle interventions have shown to reverse hyperglycemia to normoglycemia. However, most interventions are cost-intensive. Formula diets have shown to improve glycemic control and be cost-effective. We, therefore, hypothesized that adding a low-carbohydrate formula diet to a low-intense lifestyle intervention is superior in reversing prediabetes than lifestyle intervention alone. In this predefined subanalysis of a multicenter RCT (ACOORH study (no. NIHR CRN 3571)) including a total of n=463 obese subjects, overweight persons (n=141, BMI: >27 kg/m²) with prediabetes (defined as HbA1c: 5.7-6.4%) were randomized (1:2) into either a lifestyle intervention control group (CON, n=45) or a formula diet-based lifestyle intervention group (INT, n=96). Both groups were equipped with telemonitoring devices, received information on healthy diet and were instructed to increase physical activity. Additionally, INT received a low-carbohydrate, soy-protein-rich product (Almased®) substituting three meals/day (~1200 kcal) within the first week. During weeks 2-4, participants replaced two meals/day and during weeks 5-26 only one meal/day was substituted (1300-1500 kcal/day). Follow-up was performed after 52 weeks. Intention-to-treat analyses were performed. Nine and 8 persons of CON and INT (20% vs. 8%; P<0.05) dropped out after 12 weeks and 17 and 31 (38% vs. 32%, P=0.567) after 52 weeks. Compared to CON significantly more subjects in INT converted to normoglycemia after 52 weeks (51% vs. 32%; P<0.05). The risk reduction led to a number-needed-to-treat of 5.3 for INT. Concomitantly, INT reduced weight more significantly (-5.9 kg with 95% CI [-6.9; -4.9] vs. -2.4 kg [-4.0; -0.9]; P<0.001) after 12 weeks, while there was no difference after 52 weeks between groups. A low-intense lifestyle intervention with a low-carbohydrate formula diet reduces prediabetes prevalence stronger than a lifestyle intervention alone.
S. Martin: Consultant; Self; Almased Wellness GmbH, AstraZeneca, Lilly Diabetes. W. Banzer: None. A. Berg: Research Support; Self; Almased Wellness GmbH. K. Braumann: None. D. Fuhrer: Research Support; Self; Almased Wellness GmbH. M. Halle: Advisory Panel; Self; Merck Sharp & Dohme Corp. Research Support; Self; Novartis AG. Speaker's Bureau; Self; Amgen Inc., AstraZeneca, Berlin-Chemie AG, Daiichi Sankyo Company, Limited, Merck Sharp & Dohme Corp., Novartis AG, Pfizer Inc., Sanofi. D. McCarthy: None. M. Pinget: None. G. Predel: None. H. Toplak: Advisory Panel; Self; Amgen Inc., Boehringer Ingelheim Pharmaceuticals, Inc., Merck Sharp & Dohme Corp., Mylan, Novartis AG, Novo Nordisk A/S, Sanofi. Research Support; Self; Amgen Inc., Boehringer Ingelheim Pharmaceuticals, Inc., Novartis AG, Novo Nordisk A/S, Sanofi. Speaker's Bureau; Self; Amgen Inc., Amgen Inc., AstraZeneca, Bayer AG, Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, Merck Sharp & Dohme Corp., Mylan, Novo Nordisk Inc., Sanofi.
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