Ongoing Clinical Research Studies

Type 1 Diabetes and Skeletal Fragility

Adults with type 1 diabetes (T1D) have an increased risk of fractures, particularly at the hip. This clinically important problem is further compounded by the fact that patients with T1D experience poorer outcomes following a fracture. However, little is currently known about the effect of T1D on bone composition and bone quality, particularly in older adults. Our goal is to investigate biomechanical mechanisms of skeletal fragility in postmenopausal women and men age > or = to 50 years with T1D.  Using state-of-the-art methods with in vivo imaging and ex vivo examinations, our study will provide novel insights about the alterations in bone structure and quality that contribute to skeletal fragility in older adults with T1D. In addition, our findings will clarify the impact of diabetic history and accumulation of advanced glycation end-products on skeletal fragility in T1D. Addressing these critical gaps in knowledge will ultimately allow clinicians to develop rational approaches to prevent fractures in patients with T1D.

Effects of Obesity and Bariatric Surgery on Bone Health

Bariatric (weight loss) surgery is a highly effective treatment for severe obesity, but may have negative longterm consequences for the skeleton. We have previously demonstrated that the first year of gastric bypass typically leads to bone loss of 3-6% at the lumbar spine and 5-10% at the hip.  We are utilizing state-of-the art research techniques to provide a comprehensive evaluation of bone health, including metabolic bone labs, bone mineral density, bone microarchitecture, and bone marrow adiposity. Our aim is to evaluate long-term skeletal strength as evidenced by bone density and microarchitecture in adults after Roux-en-Y gastric bypass or adjustable gastric banding. We hypothesize that skeletal effects may differ based on the type of bariatric surgery. We are interested in recruiting former bariatric surgery subjects as well as non-surgical weight-matched controls. Enroll

Prevention of Bone Loss after Roux-en-Y Gastric Bypass

We are exploring the use of osteoporosis medications to augment the treatment of adults undergoing Roux-en-Y gastric bypass surgery.  We are recruiting men and women aged 50 years or older who are planning gastric bypass surgery to participate in a randomized controlled trial.  We hypothesize that using an FDA-approved osteoporosis treatment can prevent clinically relevant bone loss after gastric bypass surgery.  Enroll

Fecal Microbiota Transplant for Obesity and Metabolism

Multiple lines of evidence suggest that gut microbiota play an important role in regulating human metabolism via effects on body weight and systemic insulin resistance. In rodents, manipulation of the gut flora with fecal microbiota transfer (FMT) induces weight loss and prevents development of obesity. In human studies, FMT administered via duodenal bowel lavage may confer benefits of short-term improvements in metabolic endpoints including insulin sensitivity. Recently, a new protocol for FMT has been developed at MGH utilizing oral capsulization that greatly improves the safety and feasibility of FMT as an investigative and therapeutic tool. We are conducting a randomized placebo-controlled clinical trial of FMT capsule administration from lean metabolically healthy donors into obese recipients. Our primary objective is to study metabolic effects of FMT on body weight and insulin sensitivity. The ultimate goal is determine whether inducing sustainable changes in the gut microbiome can be developed into a therapeutic intervention for obesity and the metabolic syndrome. We are actively recruiting interested adults between ages 25 and 60 who have obesity (BMI ≥ 30kg/m2). Enroll