Background: Weight loss can resolve dysglycemia. We wanted to know whether total meal replacement (TMR) was more effective compared to a reduced-energy food based diet.

Methods: We conducted a 52-week multicenter, open-label RCT in adults with a BMI of 30-55 kg/m2. Participants (n=330) were randomized to the OPTIFAST Program (OP), a TMR diet (800-980 kcal/day) with behavioral intervention, or to a reduced-energy (-500 to -750 kcal/day) food-based diet with behavioral intervention (FB) based on the Diabetes Prevention Program. In this analysis, we studied the impact of the OP on changes in the prevalence of PREDM and DM from baseline to 26 and 52 weeks compared to FB. Endpoints were analyzed using a modified intent to treat approach, including all randomized participants who initiated treatment with at least one follow-up weight measure (n=273; 82.7%). Missing data were imputed using last observation carried forward. Statistical analysis was performed using SAS Version 9.3.

Results: Results are shown below. OP participants lost more weight and had greater improvement in HbA1c than FB. Diabetes remitted more in OP than in FB in observed cases at 26 weeks. Prediabetes prevalence decreased similarly in both groups.

Conclusions: Total meal replacement (OPTIFAST program) led to greater weight loss and had a significant impact on glycemia in participants with DM and PREDM.

    
Measure/Outcome Optifast Program(N=135) Food-Based Program(N=138)  
Age in years, mean (SD) 47.0 (11.2) 47.2 (11.3)  
Sex, n (%)    
Female 116 (85.9) 109 (79.0)  
Race, n (%)    
Caucasian 100 (74.1) 95 (68.8)  
African American 22 (16.3) 37 (26.8)  
Asian/Pacific Islander 4 (3.0) 2 (1.4)  
Hispanic 5 (3.7) 4 (2.9)  
Other 4 (3.0) 0  
Baseline characteristics    
Weight in kg, Mean (SD) 106.8 (20.8) 109.9 (23.2)  
BMI in kg/m2, Mean (SD) 38.4 (5.5) 39.2 (6.2)  
Weight change*, % of initial body weight, Mean (SD)   Difference (p value) 
26 week follow up 12.2 (0.6) 5.9 (0.6) 6.2 (p<0.01) 
52 week follow up 10.3 (0.6) 5.5 (0.6) 4.8 (p<0.01) 
HbA1c change* (%), Mean (SD)    
Baseline 5.7 (0.8) 5.7 (0.7)  
26 week follow up 5.5 (0.5) 5.6 (0.6) -0.1 (p=0.08) 
52 week follow up 5.5 (0.9) 5.7 (1.0) -0.1 (p=0.04) 
Fasting blood glucose change* (mmol/L), Mean (SD)    
Baseline 5.6 (1.5) 5.6 (1.2)  
26 week follow up 5.2 (0.9) 5.5 (1.2) -0.3 (p=0.02) 
52 week follow up 5.4 (1.8) 5.7 (1.9) -0.2 (p=0.11) 
Diabetes status = Yes** in mITT*** population    
26 week follow up 10/17 (58.8) 18/25 (72.0) p=0.07 
52 week follow up 11/17 (64.7) 20/25 (80.0) p=0.19 
Prediabetes status = Yes+ in mITT population    
26 week follow up 29/57 (50.9) 20/49 (40.8) p=0.33 
52 week follow up 29/57 (50.9) 29/49 (59.2) p=0.44 
Diabetes Status = Yes in observed++ population    
26 week follow up 7/14 (50.0) 11/16 (68.8) p=0.008 
52 week follow up 8/14 (57.1) 12/16 (75.0) p=0.31 
Prediabetes Status = Yes in observed population    
26 week follow up 17/43 (39.5) 11/34 (32.4) p=0.63 
52 week follow up 16/43 (37.2) 15/34 (44.1) p=0.64 
    
Measure/Outcome Optifast Program(N=135) Food-Based Program(N=138)  
Age in years, mean (SD) 47.0 (11.2) 47.2 (11.3)  
Sex, n (%)    
Female 116 (85.9) 109 (79.0)  
Race, n (%)    
Caucasian 100 (74.1) 95 (68.8)  
African American 22 (16.3) 37 (26.8)  
Asian/Pacific Islander 4 (3.0) 2 (1.4)  
Hispanic 5 (3.7) 4 (2.9)  
Other 4 (3.0) 0  
Baseline characteristics    
Weight in kg, Mean (SD) 106.8 (20.8) 109.9 (23.2)  
BMI in kg/m2, Mean (SD) 38.4 (5.5) 39.2 (6.2)  
Weight change*, % of initial body weight, Mean (SD)   Difference (p value) 
26 week follow up 12.2 (0.6) 5.9 (0.6) 6.2 (p<0.01) 
52 week follow up 10.3 (0.6) 5.5 (0.6) 4.8 (p<0.01) 
HbA1c change* (%), Mean (SD)    
Baseline 5.7 (0.8) 5.7 (0.7)  
26 week follow up 5.5 (0.5) 5.6 (0.6) -0.1 (p=0.08) 
52 week follow up 5.5 (0.9) 5.7 (1.0) -0.1 (p=0.04) 
Fasting blood glucose change* (mmol/L), Mean (SD)    
Baseline 5.6 (1.5) 5.6 (1.2)  
26 week follow up 5.2 (0.9) 5.5 (1.2) -0.3 (p=0.02) 
52 week follow up 5.4 (1.8) 5.7 (1.9) -0.2 (p=0.11) 
Diabetes status = Yes** in mITT*** population    
26 week follow up 10/17 (58.8) 18/25 (72.0) p=0.07 
52 week follow up 11/17 (64.7) 20/25 (80.0) p=0.19 
Prediabetes status = Yes+ in mITT population    
26 week follow up 29/57 (50.9) 20/49 (40.8) p=0.33 
52 week follow up 29/57 (50.9) 29/49 (59.2) p=0.44 
Diabetes Status = Yes in observed++ population    
26 week follow up 7/14 (50.0) 11/16 (68.8) p=0.008 
52 week follow up 8/14 (57.1) 12/16 (75.0) p=0.31 
Prediabetes Status = Yes in observed population    
26 week follow up 17/43 (39.5) 11/34 (32.4) p=0.63 
52 week follow up 16/43 (37.2) 15/34 (44.1) p=0.64 

* Change scores are adjusted for baseline value, age, sex, site, race, and diabetes status using linear mixed models.

** Diabetes status = Yes when HbA1c ≥ 6.5% or subject was on anti-diabetes medication

*** mITT population had a least 1 measured weight during follow up; if diabetes status was missing at a follow up time point, then the subject was categorized according to baseline status.

+ Prediabetes status = Yes when HbA1c 5.7%-6.4% without anti-diabetes medication

++ Observed population includes only those who had follow up at both week 26 and 52.

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Disclosure

A.E. Rothberg: Other Relationship; Spouse/Partner; Merck & Co., Inc.. Consultant; Spouse/Partner; Janssen Pharmaceuticals, Inc. J.D. Ard: Consultant; Self; Nestlé. Research Support; Self; Nestlé, VIVUS, Inc. A. Auriemma: Speaker's Bureau; Self; Novo Nordisk Inc. S.L. Coburn: Other Relationship; Self; Nestlé. K.H. Lewis: Research Support; Self; Nestlé. J. Loper: None. L.E. Matarese: Research Support; Self; Nestlé, Abbott. S. Periman: Employee; Self; Nestlé. W.J. Pories: None.

© 2018 by the American Diabetes Association.
2018
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