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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

NCT01644201 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2021-02-11

No results posted yet for this study

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

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

Sponsors & Collaborators

  • InovoBiologic Inc.

    lead INDUSTRY

Principal Investigators

  • Sean Wharton, MD, FRCPC, PharmD

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2016-11-30
Completion
2016-11-30

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01644201 on ClinicalTrials.gov