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Capsule effective in pre-diabetic patients
A new ‘smart pill’, the Gelesis100, resulted in greater weight loss in overweight and obese individuals compared with those who receive an active comparator/placebo capsule and was particularly effective in pre-diabetic patients, according to the three-month results from the First Loss Of Weight (FLOW) study presented at the joint meeting of the International Society of Endocrinology and the Endocrine Society: ICE/ENDO 2014 in Chicago.
"Given the excellent safety profile observed in the FLOW study, Gelesis100 has the potential to fulfil the unmet need for a safe and effective weight loss agent,” said Dr Hassan Heshmati, chief medical officer for Gelesis, the company behind the device and a study co-investigator. “This is particularly impactful for individuals with mildly elevated blood sugar, pre-diabetic patients, for whom weight loss is particularly important because they are at increased risk for diabetes.”
Gelesis100 (formerly Attiva) is an orally-administered capsulated device designed to cause weight loss by inducing satiety and reducing caloric intake. Gelesis100 capsules contain thousands of tiny hydrogel particles that expand in the stomach and mix with digested foods, explained Gelesis' founder and chief executive officer, Yishai Zohar.
Gelesis100 capsules are taken orally prior to a meal and contain small particles that expand ~100 times when hydrated in the stomach and small intestine. Gelesis100 has several built in safety features: a) the volume it creates is limited by the amount of water consumed, b) the hydrated particles which are ~2 mm in size, cannot aggregate to form a larger mass and have similar elasticity (rigidity) to ingested food, and c) the particles partially degrade in the colon, releasing absorbed water.
The particles absorb the water and swell to 100 times their original size in the stomach, mixing with food to create greater volume. After the particles travel through the small intestine, enzymes in the large intestine degrade them, and they release the water and are excreted.
This proof-of-concept study tested two doses of Gelesis100, a superabsorbent hydrogel, when taken twice a day with water before a meal. Forty-three subjects were randomly assigned to receive 2.25g of Gelesis100 before lunch and dinner, another 42 subjects received 3.75g of Gelesis100 and a third group of 43 subjects received a placebo capsule containing cellulose, a fibre which is used as a bulking agent. All subjects were instructed to eat 600 fewer calories a day. Neither the subjects nor the investigators knew which treatment they received during the 12 weeks of the study.
Among 125 subjects who weighed in at the start of the study and at least once after treatment, the average reductions in body weight by group at the end of treatment were as follows: 6.1 percent for 2.25g of Gelesis100, 4.5 percent for 3.75g of Gelesis100 and 4.1 percent for placebo.
For subjects receiving the 2.25g dose of Gelesis100, those with initial high fasting blood sugar (greater than the median level of 93mg/dL) had greater weight loss than did the others, losing 8.2 percent of their body weight on average.
"Gelesis100 represents an entirely new approach to treating obesity,” said lead study investigator, Dr Professor Arne Astrup, a leading obesity expert and Head of The Department of Human Nutrition, Exercise and Sports at the University of Copenhagen, Denmark. “These results are exciting and show that Gelesis100 has the potential to provide a truly novel alternative for weight loss that does not involve surgery, injections, or systemically absorbed drugs,"
The greatest weight loss reportedly occurred in prediabetic subjects whose starting fasting blood sugar level was 100 to 125.9mg/dL. They lost an average of 10.9 ± 4.3% (5.3% placebo adjusted; p=0.019) of their body weight in three months. There was a significant inverse correlation between fasting glucose at baseline and change in body weight in Gelesis100 2.25 g arm (p<0.001), contrasting with a lack of correlation in the placebo arm (P=0.708).
Heshmati said he thinks the higher dose of Gelesis100 resulted in less weight loss because of lower tolerability leading to lower compliance with the study requirements.
The most common side effects reported were bloating, flatulence, abdominal pain and diarrhoea, which he said occurred less often with the smaller dose and were tolerable at that dose. No apparent serious problems occurred in either Gelesis100 group.
"The Gelesis technology represents an important advance in material science," said Dr.Robert Langer, Institute Professor at MIT, and a leading expert in polymers and materials science. "It is the first and only superabsorbent hydrogel that I know of which is constructed from food ingredients and doesn't use potentially toxic organic solvents. By cross-linking two components together using a proprietary synthesis, Gelesis scientists created a three dimensional structure that is engineered to ideally function through the gastrointestinal tract to increase satiety and reduce hunger."