NCT03124134

Gelesis Glycemic Index Study

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Gelesis, Inc. · Industry
• Sex: Male
• Age: 22 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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

Detailed 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.

Conditions

• Obesity
• Diabetes
• PreDiabetes

Interventions

Type	Name	Description
DEVICE	Gelesis200	Encapsulated hydrogel
OTHER	Water, only (placebo)	300 mL of water

Timeline

• Start date: 2017-04-18
• Primary completion: 2017-05-18
• Completion: 2017-05-18
• First posted: 2017-04-21
• Last updated: 2018-02-15

Locations

1 site across 1 country: Canada