This project aims to prevent diabetes among a high-risk patient population with pre-diabetes. Efficacious treatments for weight management exist but are rarely discussed in primary care. Our project addresses a gap in care by making existing clinical tools easily available to primary care providers through training, electronic health record prompts, clinical decision support tools, and patient activation strategies. In collaboration with their physician, patients choose a weight management program that best meets their needs and lifestyle with an understanding of expected outcomes. This project puts risk, treatment, and predicted outcome information at the fingertips of patients and physicians and will result in an improved patient experience, increased demand for weight management discussions, improved quality of care, and prevention of diabetes through modest weight loss.
The prevalence of obesity has risen dramatically in the last few decades, affecting more than one in three adults in the United States. Presence of class II and III obesity [body mass index (BMI) >=35 kg/m2] is associated with a greater than six-fold increased risk for end-stage renal disease. We and others have shown that reductions in weight are associated with decreased urine protein, which is a marker of kidney damage. However, there is little data on long-term effects of weight loss on kidney function. At Geisinger, one in five primary care patients has a BMI >= 35 kg/m2, and over 300 patients undergo bariatric surgery each year. We are conducting retrospective studies to examine the effect of bariatric surgery-induced weight loss and kidney function. Future study includes conducting a prospective study to investigate the effect of bariatric surgery on measured kidney function. Through funding from the National Institutes of Health, we are conducting studies to determine the long-term effects of bariatric surgery on kidney function. Future goals will be to test remote dietary counseling strategies in patients with kidney disease.
Metabolic CompassThis study, funded by the American Heart Association, will encourage participants to track their timing of eating and sleep using an app developed for this study. The app will be used in a real-world population-based cohort of 1,000 participants enrolled from the PaTH Clinical Data Research Network (CDRN) to assess the relationship between timing of eating and weight after 6 months of follow-up. This study is led by Johns Hopkins University, with participation from Geisinger and UPMC.
Geisinger Rural Aging StudyThe Geisinger Rural Aging Study (GRAS) began in 1994 with more than 20,000 participants age 65 and older. The participants live in communities in rural northeastern and central Pennsylvania. Their health and nutrition has been followed over time, providing a means to study nutrition and aging.
CamelliaThe purpose of this research study is to assess whether lorcaserin HCl (brand name BELVIQ®) affects the risk of developing cardiovascular (CV) diseases in a population that has high CV risk, some of which also have type 2 diabetes and additional CV risk. In a previous Phase 3 study, lorcaserin HCl (brand name BELVIQ®) was found to significantly improve BMI, waist circumference, serum lipid profiles, blood pressure, glucose levels and other CV risk markers. There may be a favorable impact on CV risk while taking lorcaserin HCL which may cause a reduction of major adverse cardiovascular events (MACE).
SEMA-NASHThis research study is being done to compare the effect of semaglutide subcutaneous once daily versus placebo on the histological resolution of non-alcoholic steatohepatitis (NASH). Obesity can lead to the buildup of excess fat in the liver called Non-Alcoholic Fatty Liver Disease (NAFLD) and if left untreated it leads to NASH, which means there is now inflammation and tissue damage along with fat in the liver. A large number of patients who suffer from obesity have NASH. NASH can lead to cirrhosis which could lead to the need for a liver transplant. At the current time, the only treatment for NASH is diet and exercise to lose weight. The primary endpoint for this study is the resolution of NASH without the worsening of fibrosis after 72 weeks on semaglutide vs. placebo. The secondary objective of the study is to investigate which of three doses of semaglutide has the best dose-response relationship. This could potentially be the first drug approved for the treatment of NASH.
GLOW/GLOW-EXGelesis100 is a medical device (administered in standard gelatin capsules) that is capable of absorbing water solutions up to 100 times its original weight in the gastrointestinal environment. Through its mechanical and non-pharmacological approach, Gelesis100, as a medical device, is a product that is well-positioned to overcome the limitations of the current weight-loss tools and fulfill the overwhelming unmet medical need for a safe and effective weight-loss product in overweight and obese subjects, especially in those with impaired fasting glucose.
This study is designed to assess the effect of Gelesis100 vs. placebo on body weight after 6 months (GLOW). If subjects lose 3% of their body weight during the GLOW study, they are then eligible for the GLOW-EX study assessing the effect of Gelesis100 on weight loss and weight maintenance. The GLOW-EX study is an open label study of an additional 24 weeks of taking Gelesis100.