Weight Reduction by the Low-Insulin-Method-A Randomized Controlled Trial

Abstract

Continuous high insulin levels are associated with weight gain and lead to cardiometabolic diseases. Therefore, we have developed the Low-Insulin-Method and integrated it into the multi-component, occupational healthcare program SHAPE-AND-MOTION-Medical-Accompanied-Slimming (SAMMAS) to reduce daily insulin levels for long-term weight reduction in overweight or obesity. Employees were randomized into a starting intervention group (SI, n = 15) or waiting list control group (WL, n = 15). SAMMAS consisted of group-based seminars, low-carbohydrate nutrition including formula diet, continuous glucose monitoring, telemetric monitoring, and telemedical coaching. Both groups received telemetric devices at baseline. Intention-to-treat analyses were performed after 12, 26, and 52 weeks. The estimated treatment difference in weight reduction after 12 weeks, which is the primary endpoint of the study, showed a pronounced effect in favour of SI (-6.3 kg with (95% confidence interval) (-7.4; -4.5) (p < 0.001)) after 12 weeks. Furthermore, SI improved fasting blood glucose, HbA1c, quality of life, fasting insulin, blood pressure, and eating behaviour (all p < 0.05) in the within-group analysis, while WL did not. After 26 and 52 weeks, weight reduction could be maintained in the whole group (both groups together) by -6.7 kg (-9.5; -3.8) (p < 0.001) and -6.1 kg (-9.2; -2.7) (p < 0.01). SAMMAS supports clinically relevant weight reduction and long-term weight loss maintenance in individuals with overweight or obesity.

Keywords: RCT; meal replacement therapy; telemedical coaching; weight loss.

Figure 1

Flow diagram. SI, starting intervention group; WL, waiting list control group.

Figure 2

Mean changes in weight (a,b), BMI (c), HbA1c (d) and fasting insulin (e) after 12, 26, and 52 weeks of n = 30 (ITT) or n = 25 (PP). Within-group changes were analysed using mixed models adjusting for repeated measurements, baseline values and multiple testing. *** p < 0.001 vs. baseline; ** p < 0.01 vs. baseline; * p < 0.05 vs. baseline; BMI, body mass index; ITT, intention-to-treat analysis; HbA1c, haemoglobin A1c; PP, per-protocol analysis.

Figure 3

Changes in body weight of the total sample. PP-analysis with n = 25. (a) Frequency of categories of weight changes throughout the study were compared by using χ2 test (* p < 0.05). (b) Tertile stratification in baseline fasting insulin levels for weight changes in all three groups after 12, 26, and 52 weeks. Multivariable regression analyses were performed to investigate group differences and were adjusted for baseline values and multiple testing. * p < 0.05.