The Effects of Metformin and Weight Loss on Biomarkers Associated With Breast Cancer Outcomes.

Background: This study investigated the effects of metformin and weight loss on biomarkers associated with breast cancer prognosis. Methods: Overweight/obese postmenopausal breast cancer survivors (n = 333) were randomly assigned to metformin vs placebo and to a weight loss intervention vs control (ie, usual care). The 2 × 2 factorial design allows a single randomized trial to investigate the effect of two factors and interactions between them. Outcomes were changes in fasting insulin, glucose, C-reactive protein (CRP), estradiol, testosterone, and sex-hormone binding globulin (SHBG). The trial was powered for a main effects analysis of metformin vs placebo and weight loss vs control. All tests of statistical significance were two-sided. Results: A total of 313 women (94.0%) completed the six-month trial. High prescription adherence (ie, ≥80% of pills taken) ranged from 65.9% of participants in the metformin group to 81.3% of those in the placebo group (P < .002). Mean percent weight loss was statistically significantly higher in the weight loss group (-5.5%, 95% confidence interval [CI] = -6.3% to -4.8%) compared with the control group (-2.7%, 95% CI = -3.5% to -1.9%). Statistically significant group differences (ie, percent change in metformin group minus placebo group) were -7.9% (95% CI = -15.0% to -0.8%) for insulin, -10.0% (95% CI = -18.5% to -1.5%) for estradiol, -9.5% (95% CI = -15.2% to -3.8%) for testosterone, and 7.5% (95% CI = 2.4% to 12.6%) for SHBG. Statistically significant group differences (ie, percent change in weight loss group minus placebo group) were -12.5% (95% CI = -19.6% to -5.3%) for insulin and 5.3% (95% CI = 0.2% to 10.4%) for SHBG. Conclusions: As adjuvant therapy, weight loss and metformin were found to be a safe combination strategy that modestly lowered estrogen levels and advantageously affected other biomarkers thought to be on the pathway for reducing breast cancer recurrence and mortality.

Recruitment strategies, design, and participant characteristics in a trial of weight-loss and metformin in breast cancer survivors.

Weight loss and metformin are hypothesized to improve breast cancer outcomes; however the joint impacts of these treatments have not been investigated. Reach for Health is a randomized trial using a 2 × 2 factorial design to investigate the effects of weight loss and metformin on biomarkers associated with breast cancer prognosis among overweight/obese postmenopausal breast cancer survivors. This paper describes the trial recruitment strategies, design, and baseline sample characteristics. Participants were randomized in equal numbers to (1) placebo, (2) metformin, (3) weight loss intervention and placebo, or (4) weight-loss intervention and metformin. The lifestyle intervention was a personalized, telephone-based program targeting a 7% weight-loss in the intervention arm. The metformin dose was 1500 mg/day. The duration of the intervention was 6 months. Main outcomes were biomarkers representing 3 metabolic systems putatively related to breast cancer mortality: glucoregulation, inflammation, and sex hormones. Between August 2011 and May 2015, we randomized 333 breast cancer survivors. Mass mailings from the California Cancer Registry were the most successful recruitment strategy with over 25,000 letters sent at a cost of $191 per randomized participant. At baseline, higher levels of obesity were significantly associated with worse sleep disturbance and impairment scores, lower levels of physical activity and higher levels of sedentary behavior, hypertension, hypercholesterolemia, and lower quality of life (p<0.05 for all). These results illustrate the health burden of obesity. Results of this trial will provide mechanistic data on biological pathways and circulating biomarkers associated with lifestyle and pharmacologic interventions to improve breast cancer prognosis.

Teen peer educators and diabetes knowledge of low-income fifth grade students.

The current study was designed to evaluate a unique adolescent peer type 2 diabetes mellitus (Type 2 DM) prevention training program for fifth grade children. Peer educators were 22 high school students who participated in the Elementary Institute of Science's Commission on Science that Matters, a year-long program promoting active participation in the health and environmental sciences. Peer education was delivered in the form of a two hour health fair. A knowledge survey was given to fifth grade students in the classroom before the health fair began and then again in the classroom after the health fair. Fifth grade students were able to correctly identify Type 1 DM (23 vs. 40%; P < .01), Type 2 DM (21 vs. 52%; P < .001), and the signs of diabetes (10 vs. 39%; P < .001) after the health fair. This approach could be inexpensively integrated into any community-based health promotion with children and adolescents.

Outcomes from a culturally tailored diabetes prevention program in Hispanic families from a low-income school: Horton Hawks Stay Healthy (HHSH).

PURPOSE: The purpose of this study was to test the effectiveness of a minimal, tailored diabetes prevention program for families that could be delivered in elementary school settings. METHODS: Families were eligible for the program if they had at least one child aged 8 to 12 years old attending the elementary school who was at high risk of developing type 2 diabetes mellitus. Families attended ten 90-minute sessions with exercise, cooking demonstrations, and healthy lifestyle lessons. Height, weight, and self-reported behavior were assessed in parents and height and weight in children before and after classes. RESULTS: A total of 82 parents (2% men, 98% women) and 62 children (47% boys and 53% girls) enrolled in the program across 3 replications. Parents had an average weight loss from baseline to the end of the program of 1.5 lb (P = .05). There was a large increase in the number of parents who self-reported engaging in leisure-time physical activity as a result of participating in the program (14% vs 64%; P < .01). There were no changes in children's body mass index percentile or z score as a result of the program. CONCLUSIONS: Delivering a diabetes prevention program in an elementary school setting was effective for increasing diabetes-related knowledge, chronic disease awareness, and self-reported healthy behavior in low-income Spanish-speaking families.