NCT01644201

A Study Evaluating the Effects of a High Viscosity Non-starch Polysaccharide (PolyGlycopleX® - PGX®) on Glycemic Control, Cardiometabolic Risk Factors and Weight Loss in Overweight and Obese Type II Diabetics

A Randomized, Double Blind, Placebo Controlled Trial Evaluating the Effects of a Highly Viscous Non-starch Polysaccharide (PolyGlycopleX® - PGX®), on Glycemic Control, Cardiometabolic Risk Factors and Weight Loss in Overweight and Obese Type II Diabetics Enrolled in a Medically Supervised Weight Management Program.

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: InovoBiologic Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

One out of two adults in Canada is currently overweight and therefore at increased risk for a number of medical conditions including diabetes, high blood pressure, heart attacks and stroke. Obesity is less prevalent in populations consuming large amounts of dietary fibre, suggesting that fibre intake could play an important role in prevention and progression of obesity and diabetes and other conditions. Several studies have suggested that fibre has a positive effect on blood sugar and may help lower body weight. The purpose of this study is to help better understand the effect of adding fibre supplementation to a low calorie diet on blood sugar control and weight loss. The investigators hypothesize that blood sugar control will improve in participants in the fibre supplementation group. Men and women, with stable Type 2 Diabetes (e.g. no medication change in the last 3 months), between 18 - 75 years of age, and with a Body Mass Index (BMI) between 27 - 60 kg/m2 can participate in this study.

Conditions

• Type II Diabetes Mellitus
• Obesity

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	PolyGlycopleX® - PGX®	15g or 20g total daily dose, 5g pre-mixed with liquid meal replacement and consumed twice daily, 5g supplement granules sprinkled on food and consumed once of twice daily
DIETARY_SUPPLEMENT	Rice Flour (placebo)	15g or 20g total daily dose, 5g pre-mixed with liquid meal replacement and consumed twice daily, 5g supplement granules sprinkled on food and consumed once of twice daily

Timeline

• Start date: 2012-10-01
• Primary completion: 2016-11-01
• Completion: 2016-11-01
• First posted: 2012-07-19
• Last updated: 2021-02-11

Locations

1 site across 1 country: Canada