NCT03622424

Effects of Gelesis200 on Appetite Parameters, Food Intake, and Glycemic Control in Overweight or Obese Prediabetic Subjects: A Sub-Study of LIGHT-UP

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 Subjects With or Without Diabetes: A Sub-Study of LIGHT-UP

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Gelesis, Inc. · Industry
• Sex: All
• Age: 22 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Overweight and Obesity
• PreDiabetes
• Type2 Diabetes

Interventions

Type	Name	Description
DEVICE	Gelesis200	Gelesis200: Three (3)Gelesis200 capsules (2.10 g) three (3) times per day (i.e., breakfast, lunch, and dinner)
DEVICE	Placebo	Placebo: Three (3)placebo capsules three (3) times per day (i.e., breakfast, lunch, and dinner)
DEVICE	Gelesis200 and Placebo	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)

Timeline

• Start date: 2017-08-22
• Primary completion: 2019-11-19
• Completion: 2019-12-20
• First posted: 2018-08-09
• Last updated: 2022-04-04

Locations

1 site across 1 country: Denmark