Effects of Gelesis200 on Appetite Parameters, Food Intake, and Glycemic Control in Overweight or Obese Prediabetic Subjects: A Sub-Study of LIGHT-UP (MATCH)
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|ClinicalTrials.gov Identifier: NCT03622424|
Recruitment Status : Recruiting
First Posted : August 9, 2018
Last Update Posted : August 9, 2018
|Condition or disease||Intervention/treatment||Phase|
|Overweight and Obesity PreDiabetes Type2 Diabetes||Device: Gelesis200 Device: Placebo Device: Gelesis200 and Placebo||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||48 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||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 Prediabetic Subjects: A Sub-Study of LIGHT-UP|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Masking Description:||Subjects, investigators, and sponsor will be blinded|
|Official Title:||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|
|Actual Study Start Date :||August 22, 2017|
|Estimated Primary Completion Date :||September 2018|
|Estimated Study Completion Date :||November 2018|
Active Comparator: Gelesis200
Subjects on this ARM will receive Gelesis200
Gelesis200: Three (3)Gelesis200 capsules (2.10 g) three (3) times per day (i.e., breakfast, lunch, and dinner)
Placebo Comparator: Placebo
Subjects on this ARM will receive a placebo device
Placebo: Three (3)placebo capsules three (3) times per day (i.e., breakfast, lunch, and dinner)
Active Comparator: Gelesis200 and Placebo
Subejcts on this ARM will receive both Gelesis200 and placebo.
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)
- The first is placebo-adjusted weight loss of ≥3.0%from baseline to Visit 14 in prediabetic subjects or ≥2.0% in diabetic subjects on Gelesis200. [ Time Frame: 26 weeks ]Gelesis is observing if subject loose 3% or more of their body weight as a result of their participating in the study.
- weight loss of >5.0% in at least 35% of prediabetic subjects or in at least 25% of diabetic subjects on Gelesis200. [ Time Frame: 26 weeks ]Gelesis is observing if pre-diabetic or 25% type 2 diabetic subject loose 5% or more of their body weight as a result of their participating in the study.
- statistically significant improvement in HbA1c comparing Gelesis200 to placebo in diabetic subjects [ Time Frame: 26 weeks ]Gelesis is observing if subject on Gelesis200 improved their HbA1c better than those on placebo.
- improvement in FPG status, post-OGTT plasma glucose status, or post-OGTT plasma glucose AUC in ≥50% of subjects on Gelesis200. [ Time Frame: 26 weeks ]Gelesis is observing if greater than 50% of subject on Gelesis200 improved FPG status, post-OGTT plasma glucose status, or post-OGTT plasma glucose AUC.
- Number of TEAE for Gelesis200 similar to placebo or clinically acceptable. [ Time Frame: 26 weeks ]Gelesis is continue to observe safety and tolerability profiles on subjects taking Gelesis200.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03622424
|Contact: Diana Peremislov, Ph.D.||612 234 8500 ext firstname.lastname@example.org|
|Contact: Henry W Calderon, BS||617 651 email@example.com|
|University of Copenhagan||Recruiting|
|Frederiksberg, Denmark, DK-1958|
|Contact: Anders M Sjodin, MD 45 35 33 24 70 firstname.lastname@example.org|
|Study Director:||Hassan Heshmati, MD||Gelesis, Inc.|