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The Effect of NVFS on GC in Individuals With DM: SR & MA of RCTs (NVFS&GC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03259724
Recruitment Status : Unknown
Verified August 2017 by St. Michael's Hospital, Toronto.
Recruitment status was:  Active, not recruiting
First Posted : August 24, 2017
Last Update Posted : August 24, 2017
Sponsor:
Information provided by (Responsible Party):
St. Michael's Hospital, Toronto

Brief Summary:

Purpose of Study (The Effect of Non-Viscous Fibre Supplementation on Glycemic Control (NVFS & GC) in Individuals with Diabetes Mellitus.

Regardless of the remarkable advancement in pharmacotherapy, diabetes mellitus remains a major concern with more than 300 millions living with its complications including CVD. Nutrition is a cornerstone in diabetes management, and increasing total dietary fibre have been shown to decrease HbA1c, fasting glucose, fasting insulin, fructosamine, and HOMA-IR. However, the main underlying mechanism is still not fully understood, and the specific type and proportion of fibre supplementation to be recommended for such individuals is still controversial.

Currently, the available findings/ results from small RCTs are inconsistent. The systematic review method depends on combining data from many small studies in order a pooled estimate of the pooled effect. The purpose of this study is to conduct a systematic review and meta-analysis of randomized controlled trials (RCTs) assessing the effect of non-viscous fibre supplementation on fasting glucose and insulin in individuals with diabetes mellitus. We hope the findings of this study will play a role in developing the nutritional guidelines for individuals with diabetes mellitus.


Condition or disease
Diabetes Mellitus

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Study Type : Observational
Estimated Enrollment : 514 participants
Observational Model: Other
Time Perspective: Other
Official Title: The Effect of Non-Viscous Fibre Supplementation on Glycemic Control in Individuals With Diabetes Mellitus: A Systematic Review & Meta-analysis of RCTs
Actual Study Start Date : January 30, 2017
Actual Primary Completion Date : June 30, 2017
Estimated Study Completion Date : August 30, 2017



Primary Outcome Measures :
  1. HbA1c [ Time Frame: ≥ 3 weeks ]
    Glycated Hemoglobin A1C


Secondary Outcome Measures :
  1. FG [ Time Frame: ≥ 3 weeks ]
    Fasting Glucose

  2. FI [ Time Frame: ≥ 3 weeks ]
    Fasting Insulin

  3. Fructomsamine [ Time Frame: ≥ 3 weeks ]
  4. HOMA-IR [ Time Frame: ≥ 3 weeks ]
    Insulin Resistance



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Individuals with T1DM or T2DM
Criteria

Inclusion Criteria:

  • Randomized
  • Properly controlled
  • ≥ 3 weeks
  • Non-viscous fibre supplementation intervention
  • Glycemic control endpoints
  • Individuals with DM

Exclusion Criteria:

  • Non-randomized
  • Not controlled
  • < 3 weeks
  • Viscous fibre supplementation as intervention or placebo
  • Healthy individuals or individuals with conditions other than DM

Information from the National Library of Medicine

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): NCT03259724


Locations
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Canada, Ontario
The Toronto 3D Knowledge Synthesis and Clinical Trials Unit, Clinical Nutrition and Risk Factor Modification Centre
Toronto, Ontario, Canada, M5C 2T2
Sponsors and Collaborators
St. Michael's Hospital, Toronto
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Responsible Party: St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier: NCT03259724    
Other Study ID Numbers: NVFS&GC Meta
First Posted: August 24, 2017    Key Record Dates
Last Update Posted: August 24, 2017
Last Verified: August 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases