Gelesis Glycemic Index Study — GLIDE  

Obesity Clinical Trial

Official title: A Randomized, Open-label, Crossover Study Assessing the Effects of Gelesis200 on Glucose and Insulin Following a Single Administration of Gelesis200 in Healthy Subjects

Status Completed

Clinical Trial Summary

A study to determine glucose and insulin responses to 50g and 100 g of carbohydrate with and without Gelesis200.

Clinical Trial Description

This will be a single centre, open-label, randomized, single-administration, 4-period, 4-way, crossover, pilot study with glycemic and insulin assessments. There is also an option for 2 additional single-administration periods based on the results of an interim analysis.

The study includes 2 treatments arms with Gelesis200 (4.20 g 10 minutes before a 50 g carbohydrate breakfast and 4.20 g 10 minutes before a 100 g carbohydrate breakfast) plus 2 control arms consisting of consumption of the breakfasts with water only.

The optional periods consist of 1 treatment arm with Gelesis200 and 1 control arm with breakfast and water only. Either only one or both the optional periods may be conducted. The number of additional period(s) to conduct, the amount of Gelesis200 in the treatment arm, as well as the meal composition will be based on interim analysis results. ;

Related Conditions & MeSH terms

• Diabetes
• Obesity
• PreDiabetes
• Prediabetic State

• NCT number: NCT03124134
• Study type: Interventional
• Source: Gelesis, Inc.
• Status: Completed
• Phase: N/A
• Start date: April 18, 2017
• Completion date: May 18, 2017