Gelesis Announces Initiation Of The 6-Month Weight Loss Study With Gelesis100

The GLOW (Gelesis Loss Of Weight) research is a six-month, randomized, placebo-controlled, double-blind, parallel-group research designed to further assess the result of Gelesis100 on body weight as well as glycemic control parameters in over weight and obese subject matter, including pre-diabetics and also type 2 diabetes.

Gelesis, a bio-technology company focused on the development regarding first-in-class therapeutics to induce weight loss and also improve glycemic control, announced today which it has initiated the GLOW research.

The GLOW study will measure the effect of repeated administration of Gelesis100 over 6 months on body weight as well as glycemic control parameters in 168 overweight and also obese sufferers, including prediabetics in addition to type 2 diabetics. The research is going to be conducted in 10 sites in Europe and the USA. The primary endpoints for the GLOW research are change in whole body weight from baseline to end of randomized treatment and also percent of patients with at least five percent weight-loss. The secondary endpoints incorporate changes in key glycemic control guidelines.

"We designed the particular GLOW study to assess the safety and efficiency of Gelesis100 over a longer period of time on the broader patient population, including type two diabetics, as in comparison to the First Loss Of Weight (FLOW) analyze, " said Hassan Heshmati, CMO regarding Gelesis. "We are desirous to further build when the FLOW research, that resulted in statistically significant weightloss over three months in overweight and also obese patients. "

About Obesity:

Morbid obesity, a serious medical condition that is speedily growing in prevalence worldwide, is a significant risk factor intended for developing pre-diabetes and also type 2 diabetes. In accordance with a 2012 Centers for Disease Control (CDC) report, around 79 million Us residents were obese, and as much as 77 million Us residents were considered overweight, with many anticipated to cross the threshold into obesity in the future.

About Prediabetes and also Type 2 Diabetes:

Type 2 diabetes is usually marked by abnormal blood sugar levels which, in case left untreated, can result in serious complications which includes death. The American Diabetes Association cited type 2 diabetes since the seventh leading reason for death by disease in the US in 2010. Within 2012, approximately 26 million Americans experienced type 2 diabetes, and more than 85% of the Americans were overweight or obese. An additional eighty six million American adults older than 20 years had been considered prediabetic (defined by the fasting blood sugar level >/= 100 mg/dL and < 126 mg/dL), along with approximately 1. 7 million new diagnoses of type 2 diabetes per year.

About Gelesis100:

Gelesis100 is usually a non-systemic, orally administered capsule created to induce weight loss. Each capsule contains 1000s of proprietary, biocompatible hydrogel particles synthesized along with starting materials which are Generally Recognized since Safe (GRAS) by the U. S. Food and also Drug Administration (FDA). Gelesis100 capsules usually are taken prior to a meal with drinking water, after which the little particles within the capsules hydrate and expand inside the stomach and little intestine, triggering various important satiety and also glycemic control mechanisms. Gelesis100 has several inbuilt safety features: a) the volume it creates is restricted by the quantity of water consumed, b) the hydrated particles, that are two millimeters in dimensions, do not cluster or stick together and also have absolutely similar elasticity (rigidity) since ingested food, and c) the particles partially degrade within th colon, releasing consumed water.

About Gelesis:

Gelesis is usually a clinical stage company focused on the development regarding novel therapies to induce weight-loss and improve glycemic manage in overweight as well as obese patients. The Gelesis exec and advisory team includes a few of the world's leading specialists in obesity study and clinical progress, entrepreneurs, and innovators within advanced materials. Gelesis had been co-founded by PureTech, the science and technology R&D company.

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Weight Loss Counseling Research Required, Study Shows

As obesity rates inside U. S. keep climb health researchers have begun to analyze many different factors that may affect weight. A whole new study suggests, even so, that there may not be sufficient research in to how doctors can certainly encourage already-proven methods for weight loss.

The study, published from The Journal of the American Medical Association, reviewed studies about how exactly doctors can work with behavioral treatment intended for obese patients. This study found only 12 high-quality studies within the issue, and no studies where doctors followed this Centers for Medicare and also Medicaid Services’ (CMS) tips for behavioral counseling.

“After an inclusive search, we discovered only 12 high-quality randomized handled trials that examined the behavioral treatment method of obesity within patients encountered inside primary care configurations, ” said Thomas Wadden, lead author from the study and director on the University of Pennsylvania’s Centre for Weight in addition to Eating Disorders. “Of those, only two studies recognized counseling interventions that produced the average loss of at least five percent of initial bodyweight, an amount more likely to improve weight-related health and fitness complications. ”

Wadden along with his colleagues discovered that, of the 12 studies covered inside review, those that applied behavioral interventions that included a reduced-calorie eating plan and prescribed physical exercise were generally best. A higher quantity of counseling visits in the first six months of the behavioral treatment intended for obesity was also found for being associated with greater weight loss.

In 2011 this CMS approved payment for behavioral weight loss counseling, but only under strict guidelines that need CMS-approved primary health care practicioners. The study’s authors believe that more research is needed to determine the effectiveness of such guidelines. They also advised that remote weight loss counseling via telephone or the online world could be effective.

“I think we will probably see increasing use of remotely-delivered weight loss counseling, whether by simply telephone, smart phones, the Internet, or other digital solutions, ” said Adam Tsai, a co-author from the study and the obesity specialist at Kaiser Permanente in Denver. “Telephone delivered guidance, provided by counselors from the patient’s primary health care practice, or by a trained interventionist from the disease management contact center, is probably be more convenient and less expensive for patients in addition to potentially for health-care providers and insurance providers. ”.

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