IMAGES (transIt tiMe And Gastric Emptying Study)
Research type
Research Study
Full title
A randomized, partially-blinded, cross-over scintigraphic study to investigate the effect of Gelesis100 on gastric emptying in overweight and obese subjects
IRAS ID
184434
Contact name
Howard Stevens
Contact email
Sponsor organisation
Gelesis Inc
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 6 months, 0 days
Research summary
Gelesis100 is a new, experimental medical device which has been developed by Gelesis, Inc. (a US-based company) to aid weight loss in overweight/obese patients by reducing the amount of food required to make them feel full. The device is contained in a capsule which is swallowed with water before a meal. Once swallowed, the capsule dissolves and the capsule contents hydrate and mix with the food in the stomach, creating a feeling of fullness.
Four different treatments of up to 5 capsules each will be given to participants during this study. These will be a mixture of the Gelesis100 capsules and capsules which do not contain the device i.e., they are placebo (will contain sucrose [sugar]).
We will be looking at:
• The time it takes for the stomach to empty once receiving each treatment
• The time it takes for food and Gelesis100 to travel through the intestine
• The effects of Gelesis100 on the feeling of satiety (how full participants feel)In order to monitor gastrointestinal behaviour, we will either add a small amount of radioactive material to a component of the lunch (Treatments 1-3) or to the water given with the treatment (Treatment 4). The radiation emitted will then be detected by taking images using a device known as a gamma camera. The procedure is relatively easy and non-invasive.
REC name
West of Scotland REC 4
REC reference
15/WS/0140
Date of REC Opinion
14 Aug 2015
REC opinion
Favourable Opinion