Accelerating regulatory progress in multi-institutional research.

PURPOSE: Multi-institutional collaborations are necessary in order to create large and robust data sets that are needed to answer important comparative effectiveness research (CER) questions. Before scientific work can begin, a complex maze of administrative and regulatory requirements must be efficiently navigated to avoid project delays. INNOVATION: Staff from research, regulatory, and administrative teams involved in three HMO Research Network (HMORN) multi-institutional collaborations developed and employed novel approaches: to secure and maintain Institutional Review Board (IRB) approvals; to enable data sharing, and to expedite subawards for two data-only minimal risk studies. These novel approaches accelerated required processes and approvals while maintaining regulatory, human subjects, and institutional protections. CREDIBILITY: Outcomes from the processes described here are compared with processes outlined in the research and regulatory literature and with processes that have been used in previous multisite research collaborations. CONCLUSION AND DISCUSSION: Research, regulatory, and administrative staff are essential contributors to the success of multi-institutional collaborations. Their flexibility, creativity, and effective communication skills can lead to the development of efficient approaches to achieving the necessary oversight for these complex projects. Elements of these specific strategies can be adapted and used by other research networks. Other efforts in these areas should be evaluated and shared. The processes that help develop a "learning research system" play an important and complementary role in sustaining multi-institutional research collaborations.

"Energy Up": a novel approach to the weight management of inner-city teens.

There are few successful adolescent obesity prevention programs. We evaluated "Energy Up," an innovative program for inner-city girls that focuses on addictive food avoidance, exercise, and self-esteem building. Over a 9-month period, obese participants lost 12.9 pounds and overweight participants lost 2.9 pounds, prompting expansion to other schools.

School-based intervention acutely improves insulin sensitivity and decreases inflammatory markers and body fatness in junior high school students.

CONTEXT: Risk factors for type 2 diabetes mellitus (T2DM) include obesity, family history, dyslipidemia, a proinflammatory state, impaired insulin secretory capacity, and insulin resistance. OBJECTIVE: The aim of this study was to examine the effects of a 3- to 4-month school-based intervention consisting of health, nutrition, and exercise classes plus an aerobic exercise program on diabetes risk. DESIGN: This study was a randomized before/after controlled trial. METHODS: Seventy-three eighth-grade students in a predominantly Hispanic New York City public school were divided into a control group (studied twice without receiving the intervention) and an experimental group (studied before and after the intervention). OUTCOME MEASURES: We measured body fatness (bioelectrical impedance), insulin sensitivity, beta-cell function (insulin release in response to an iv glucose load corrected for insulin sensitivity), lipid profiles, and circulating concentrations of IL-6, C-reactive protein, adiponectin, and TNF-alpha. RESULTS: Participation in the intervention was associated with significant reductions in body fatness, insulin resistance, and circulating concentrations of C-reactive protein and IL-6, irrespective of somatotype on enrollment. CONCLUSION: Short-term school-based health, nutrition, and exercise intervention is beneficial to all students and affects multiple diabetes risk factors.

beta-Cell function and insulin sensitivity in early adolescence: association with body fatness and family history of type 2 diabetes mellitus.

The prevalence of type 2 diabetes mellitus (T2DM) among adolescents has increased 5- to 10-fold over the past decade. T2DM results from pancreatic beta-cell dysfunction and insulin resistance. Using rapid iv glucose tolerance testing, we examined beta-cell function and insulin resistance in 72 predominantly Latino eighth grade students (41 males and 31 females; mean +/- sem age, 13.6 +/- 0.1 yr). Thirty-six percent of the children had body mass indexes above the 85th percentile for age and gender, and 50% had a first- or second-degree relative with T2DM. Overweight children were five times more likely to be in the highest quartile for insulin resistance. Children with a family history of T2DM were five times more likely to be in the lowest quartile for insulin secretory capacity, 4.5 times more likely to be in the lowest quartile for glucose disposal, and three times more likely to be in the lowest quartile for insulin resistance. These findings are consistent with a model for the physiology of T2DM in which a familial beta-cell dysfunction is unmasked by increasing insulin resistance secondary to overweight in this predominantly Latino population.