<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03259724</url>
  </required_header>
  <id_info>
    <org_study_id>NVFS&amp;GC Meta</org_study_id>
    <nct_id>NCT03259724</nct_id>
  </id_info>
  <brief_title>The Effect of NVFS on GC in Individuals With DM: SR &amp; MA of RCTs</brief_title>
  <acronym>NVFS&amp;GC</acronym>
  <official_title>The Effect of Non-Viscous Fibre Supplementation on Glycemic Control in Individuals With Diabetes Mellitus: A Systematic Review &amp; Meta-analysis of RCTs</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Unity Health Toronto</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Unity Health Toronto</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Purpose of Study (The Effect of Non-Viscous Fibre Supplementation on Glycemic Control (NVFS &amp;&#xD;
      GC) in Individuals with Diabetes Mellitus.&#xD;
&#xD;
      Regardless of the remarkable advancement in pharmacotherapy, diabetes mellitus remains a&#xD;
      major concern with more than 300 millions living with its complications including CVD.&#xD;
      Nutrition is a cornerstone in diabetes management, and increasing total dietary fibre have&#xD;
      been shown to decrease HbA1c, fasting glucose, fasting insulin, fructosamine, and HOMA-IR.&#xD;
      However, the main underlying mechanism is still not fully understood, and the specific type&#xD;
      and proportion of fibre supplementation to be recommended for such individuals is still&#xD;
      controversial.&#xD;
&#xD;
      Currently, the available findings/ results from small RCTs are inconsistent. The systematic&#xD;
      review method depends on combining data from many small studies in order a pooled estimate of&#xD;
      the pooled effect. The purpose of this study is to conduct a systematic review and&#xD;
      meta-analysis of randomized controlled trials (RCTs) assessing the effect of non-viscous&#xD;
      fibre supplementation on fasting glucose and insulin in individuals with diabetes mellitus.&#xD;
      We hope the findings of this study will play a role in developing the nutritional guidelines&#xD;
      for individuals with diabetes mellitus.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background: High fibre diets have been recommended for individuals with diabetes mellitus.&#xD;
      However, the findings on the effect of non-viscous fibre supplementation such as inulin,&#xD;
      wheat bran and resistant starch on glycemic control in individuals with diabetes are&#xD;
      inconsistent.&#xD;
&#xD;
      Objective: In order to improve the evidence-based guidelines for diabetes mellitus, we will&#xD;
      conduct a systematic review and meta-analysis to assess evidence from randomized controlled&#xD;
      trials (RCTs) on the effect of non-viscous fibre supplementation on glycemic control in&#xD;
      individuals with diabetes.&#xD;
&#xD;
      Design: Cochrane handbook for systematic review of interventions will be used for planning&#xD;
      and conducting this meta-analysis. The reporting will follow the Preferred Reporting Items&#xD;
      for Systematic Reviews and Meta-analysis (PRISMA) guidelines.&#xD;
&#xD;
      Data sources: MEDLINE, EMBASE, the Cochrane Central Register for Controlled Trials will be&#xD;
      searched using appropriate pre-determined search terms.&#xD;
&#xD;
      Study selection: All the included trials must be randomized, controlled, with duration of ≥ 3&#xD;
      weeks investigating the effect of supplementing diet with non-viscous fiber on glycemic&#xD;
      control outcomes in individuals with diabetes mellitus. Acute studies, non-randomized, not&#xD;
      appropriately controlled studies will be excluded. Both isocaloric and non-isocaloric will be&#xD;
      included.&#xD;
&#xD;
      Data extraction: Two independent reviewers will extract information about fiber type, sample&#xD;
      size, subject characteristics, dose, follow-up, composition of the background diets, and&#xD;
      statistical analyses. Mean±SEM values will be extracted for all outcomes. Standard&#xD;
      computation and imputation will be used to derive all missing variance data. Risk of bias and&#xD;
      study quality will be assessed using the Cochrane Risk of Bias Tool and the Grading of&#xD;
      Recommendations Assessment, Development and Evaluation (GRADE), respectively.&#xD;
&#xD;
      Outcome: This meta-analysis will assess a set of outcomes related to glycemic control in&#xD;
      individuals with diabetes mellitus. These outcomes are: (1) glycated hemoglobin A1c (HbA1c)&#xD;
      or (2) fructosamine, (3) fasting glucose (FG), (4) fasting insulin (FI), and (5) Homeostasis&#xD;
      model assessment of insulin resistance (HOMA-IR).&#xD;
&#xD;
      Data synthesis: Pooled analysis will be conducted using the Generic Inverse Variance method.&#xD;
      Rand-effects models will be used even in the absence of statistical significant between-study&#xD;
      heterogeneity because they yield more conservative summary effect estimates in the presence&#xD;
      of residual heterogeneity. Heterogeneity will be assessed using Cochran's Q test and&#xD;
      quantified by the I2 statistic. Sensitivity and subgroup analyses will be used to explore&#xD;
      sources of heterogeneity. A priori subgroup analyses include study design, does, fiber type,&#xD;
      follow-up (duration), baseline values, study quality, food matrix, and composition of the&#xD;
      background diet. The significance of subgroup analyses will be assessed using meta-regression&#xD;
      analyses. Publication bias will be assessed using the inspection of funnel plots and&#xD;
      application of Egger's and Begg's tests.&#xD;
&#xD;
      Knowledge translation plan: Results will be shared through traditional, national, and&#xD;
      international scientific meetings and they may be submitted to high impact factor journals&#xD;
      for publication.&#xD;
&#xD;
      Significance: We hope the results of this study will play a role in improving the guidelines/&#xD;
      recommendations for individuals with diabetes mellitus by raising the awareness towards&#xD;
      viscous fiber consumption among health providers, patients, and industry. Hopefully, this&#xD;
      study will aid in guiding future research in the dietary fiber field.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">January 30, 2017</start_date>
  <completion_date type="Anticipated">August 30, 2017</completion_date>
  <primary_completion_date type="Actual">June 30, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>HbA1c</measure>
    <time_frame>≥ 3 weeks</time_frame>
    <description>Glycated Hemoglobin A1C</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>FG</measure>
    <time_frame>≥ 3 weeks</time_frame>
    <description>Fasting Glucose</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>FI</measure>
    <time_frame>≥ 3 weeks</time_frame>
    <description>Fasting Insulin</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fructomsamine</measure>
    <time_frame>≥ 3 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HOMA-IR</measure>
    <time_frame>≥ 3 weeks</time_frame>
    <description>Insulin Resistance</description>
  </secondary_outcome>
  <enrollment type="Anticipated">514</enrollment>
  <condition>Diabetes Mellitus</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Individuals with T1DM or T2DM&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Randomized&#xD;
&#xD;
          -  Properly controlled&#xD;
&#xD;
          -  ≥ 3 weeks&#xD;
&#xD;
          -  Non-viscous fibre supplementation intervention&#xD;
&#xD;
          -  Glycemic control endpoints&#xD;
&#xD;
          -  Individuals with DM&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Non-randomized&#xD;
&#xD;
          -  Not controlled&#xD;
&#xD;
          -  &lt; 3 weeks&#xD;
&#xD;
          -  Viscous fibre supplementation as intervention or placebo&#xD;
&#xD;
          -  Healthy individuals or individuals with conditions other than DM&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>The Toronto 3D Knowledge Synthesis and Clinical Trials Unit, Clinical Nutrition and Risk Factor Modification Centre</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5C 2T2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 21, 2017</study_first_submitted>
  <study_first_submitted_qc>August 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 24, 2017</study_first_posted>
  <last_update_submitted>August 21, 2017</last_update_submitted>
  <last_update_submitted_qc>August 21, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 24, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03259724
org study id: NVFS&GC Meta
nct id: NCT03259724
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
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.
Background: High fibre diets have been recommended for individuals with diabetes mellitus.
      However, the findings on the effect of non-viscous fibre supplementation such as inulin,
      wheat bran and resistant starch on glycemic control in individuals with diabetes are
      inconsistent.

      Objective: In order to improve the evidence-based guidelines for diabetes mellitus, we will
      conduct a systematic review and meta-analysis to assess evidence from randomized controlled
      trials (RCTs) on the effect of non-viscous fibre supplementation on glycemic control in
      individuals with diabetes.

      Design: Cochrane handbook for systematic review of interventions will be used for planning
      and conducting this meta-analysis. The reporting will follow the Preferred Reporting Items
      for Systematic Reviews and Meta-analysis (PRISMA) guidelines.

      Data sources: MEDLINE, EMBASE, the Cochrane Central Register for Controlled Trials will be
      searched using appropriate pre-determined search terms.

      Study selection: All the included trials must be randomized, controlled, with duration of ≥ 3
      weeks investigating the effect of supplementing diet with non-viscous fiber on glycemic
      control outcomes in individuals with diabetes mellitus. Acute studies, non-randomized, not
      appropriately controlled studies will be excluded. Both isocaloric and non-isocaloric will be
      included.

      Data extraction: Two independent reviewers will extract information about fiber type, sample
      size, subject characteristics, dose, follow-up, composition of the background diets, and
      statistical analyses. Mean±SEM values will be extracted for all outcomes. Standard
      computation and imputation will be used to derive all missing variance data. Risk of bias and
      study quality will be assessed using the Cochrane Risk of Bias Tool and the Grading of
      Recommendations Assessment, Development and Evaluation (GRADE), respectively.

      Outcome: This meta-analysis will assess a set of outcomes related to glycemic control in
      individuals with diabetes mellitus. These outcomes are: (1) glycated hemoglobin A1c (HbA1c)
      or (2) fructosamine, (3) fasting glucose (FG), (4) fasting insulin (FI), and (5) Homeostasis
      model assessment of insulin resistance (HOMA-IR).

      Data synthesis: Pooled analysis will be conducted using the Generic Inverse Variance method.
      Rand-effects models will be used even in the absence of statistical significant between-study
      heterogeneity because they yield more conservative summary effect estimates in the presence
      of residual heterogeneity. Heterogeneity will be assessed using Cochran's Q test and
      quantified by the I2 statistic. Sensitivity and subgroup analyses will be used to explore
      sources of heterogeneity. A priori subgroup analyses include study design, does, fiber type,
      follow-up (duration), baseline values, study quality, food matrix, and composition of the
      background diet. The significance of subgroup analyses will be assessed using meta-regression
      analyses. Publication bias will be assessed using the inspection of funnel plots and
      application of Egger's and Begg's tests.

      Knowledge translation plan: Results will be shared through traditional, national, and
      international scientific meetings and they may be submitted to high impact factor journals
      for publication.

      Significance: We hope the results of this study will play a role in improving the guidelines/
      recommendations for individuals with diabetes mellitus by raising the awareness towards
      viscous fiber consumption among health providers, patients, and industry. Hopefully, this
      study will aid in guiding future research in the dietary fiber field.
observational model: Other
time perspective: Other
measure: HbA1c
time frame: ≥ 3 weeks
description: Glycated Hemoglobin A1C
measure: FG
time frame: ≥ 3 weeks
description: Fasting Glucose
measure: FI
time frame: ≥ 3 weeks
description: Fasting Insulin
measure: Fructomsamine
time frame: ≥ 3 weeks
measure: HOMA-IR
time frame: ≥ 3 weeks
description: Insulin Resistance
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Diabetes Mellitus