Effects of Gelesis200 on Appetite Parameters, Food Intake, and Glycemic Control in Overweight or Obese Prediabetic Subjects: A Sub-Study of LIGHT-UP
Condition: Overweight and Obesity; PreDiabetes; Type2 Diabetes
MeSH terms: Overweight
Study type: Interventional

Summary: 
      This study evaluates the effects of Gelesis200 on Appetite Parameters, Food Intake, and
      Glycemic Control in Overweight or Obese Prediabetic Subjects: A Sub-Study of LIGHT-UP. Some
      of the patients will receive Gelesis200, the other will receive a combination of Gelesis200
      and placebo and the final group will receive just placebo.
    

Detailed description: 
      Overweight (BMI ≥25 and <30kg/M2) and obesity (BMI ≥30kg/M2) are major health problems,
      world-wide. The overweight/obesity epidemic was first noted in the US and then spread to
      other industrialized nations, and is now seen even in developing countries. The World Health
      Organization (WHO) estimated that the worldwide prevalence of obesity has nearly doubled
      between 1980 and 2008, and in a separate analysis, the NCD Risk Factor Collaboration (NCD
      RisC) and the WHO estimated that the worldwide prevalence of diabetes has nearly quadrupled
      between 1980 and 2014, from 108 million to 422 million, respectively.

      The intra-gastric balloon is an intervention designed to reduce stomach volume, but there are
      conflicting data on sustained weight loss and no clear data indicating a decrease in
      mortality. Side effects include balloon movement, nausea, vomiting, pain, and stomach
      ulceration. The results from bariatric surgery suggest that limiting the functional volume of
      the stomach is an effective modality for the treatment of obesity. However, because of the
      invasive nature of the procedure, associated risk of peri-operative complications and the
      relatively high cost, bariatric surgery is usually reserved for the severely obese subjects.
      A need exists for a product that is easy to use, safe, convenient, more accessible, and
      effective at inducing and sustaining weight loss. Interventions which act mechanically by
      occupying stomach volume, increasing the elasticity and viscosity of the upper
      gastrointestinal content, and extending gastric emptying time, could potentially be very
      beneficial.A medical device which induces satiety and decreases hunger could result in
      decreased caloric intake and weight loss. The advantage of such a medical device is that it
      would not require drastic restriction of food choices and would circumvent the challenge of
      unacceptable hunger levels which have derailed so many dietary interventions in the past.

      Gelesis200, when hydrated, is homogeneously mixed with the ingested food,increasing the
      volume and elasticity of the stomach and small intestine contents. This in turn may induce
      satiety,which reduces food intake. Previous studies with a similar hydrogel (Gelesis100) have
      shown increased satiety,reduced body weight(especially in prediabetics), and improved
      glycemic control. It is expected that Gelesis200 will have similar effects to Gelesis100.
      Furthermore, the physical properties of Gelesis200 (viscosity), which are similar to some
      dietary fibers, suggest that Gelesis200 will have a favorable impact on glycemic control.
    

Intervention name(s): Gelesis200; Placebo; Gelesis200 and Placebo
Intervention type(s): Device; Device; Device
Intervention description(s): Gelesis200: Three (3)Gelesis200 capsules (2.10 g) three (3) times per day (i.e., breakfast, lunch, and dinner); Placebo: Three (3)placebo capsules three (3) times per day (i.e., breakfast, lunch, and dinner); Placebo and Gelesis200: Three (3) placebo capsules at breakfast,and three (3) Gelesis200 capsules (2.10 g)two (2) times per day (i.e., lunch and dinner)
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Assessing the Effects of Gelesis200 on Appetite Parameters, Food Intake, and Glycemic Control in Overweight or Obese Prediabetic Subjects: A Sub-Study of LIGHT-UP
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment