Study Stopped
Too slow recruitment
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.
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Oct 2012
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 16, 2012
CompletedFirst Posted
Study publicly available on registry
July 19, 2012
CompletedStudy Start
First participant enrolled
October 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2016
CompletedFebruary 11, 2021
August 1, 2015
4.1 years
July 16, 2012
February 8, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
HbA1c
End of study (1 year)
Study Arms (2)
High viscosity non-starch polysaccharide, PolyGlycopleX®-PGX®
ACTIVE COMPARATORPlacebo (Rice Flour)
PLACEBO COMPARATORInterventions
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
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
- Monoamine oxidase inhibitors (MAOIs) such as tranylcypromine, (Parnate), isocarboxazid (Marplan) and phenelzine (Nardil)
- Tetracyclic such as Mirtazapine (Remeron)
- Serotonin antagonist and reuptake inhibitors (SARI) such as Trazodone
- SSRIs such as citalopram (Celexa), escitalopram (Lexapro), fluvoxamine (Luvox), fluoxetine (Prozac), sertraline (Zoloft), paroxetine (Paxil)
- Wellbutrin
- +30 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Wharton Medical Clinic and Weight Management Centre
Hamilton, Ontario, Canada
Related Publications (1)
Reimer RA, Wharton S, Green TJ, Manjoo P, Ramay HR, Lyon MR, Gahler RJ, Wood S. Effect of a functional fibre supplement on glycemic control when added to a year-long medically supervised weight management program in adults with type 2 diabetes. Eur J Nutr. 2021 Apr;60(3):1237-1251. doi: 10.1007/s00394-020-02328-8. Epub 2020 Jul 8.
PMID: 32642971DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sean Wharton, MD, FRCPC, PharmD
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 16, 2012
First Posted
July 19, 2012
Study Start
October 1, 2012
Primary Completion
November 1, 2016
Study Completion
November 1, 2016
Last Updated
February 11, 2021
Record last verified: 2015-08