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.
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Type II Diabetes Mellitus
- Sponsor
- InovoBiologic Inc.
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- HbA1c
- Status
- Terminated
- Last Updated
- 5 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •18-75 years of age (if \>65 years of age, enrolment at the discretion of qualified investigator)
- •BMI 27-60 Kg/m2
- •Stable Type 2 diabetes mellitus (i.e. no medication change in the last 3 months)
- •Ability to provide written informed consent in accordance with Good Clinical Practice (GCP) and local legislation
Exclusion Criteria
- •HbA1c \<7.0% or \>10.0%
- •History of any bariatric surgery
- •\>10 Kg weight gain or weight loss in the past 3 months
- •Known eating disorder
- •Participant has taken weight loss medication in the last 3 months (eg. Meridia, Xenical)
- •Participant is taking any of the following medications that can alter body weight or appetite:
- •Antipsychotics or neuroleptics
- •Prednisone
- •Antidepressants
- •Tricyclic such as amitriptyline, imipramine (Tofranil), and doxepin (Sinequan)
Outcomes
Primary Outcomes
HbA1c
Time Frame: End of study (1 year)