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Meta-analyses of Impotrant Food Sources of Sugars and Incident Cardiometabolic Diseases

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ClinicalTrials.gov Identifier: NCT02702375
Recruitment Status : Unknown
Verified May 2016 by John Sievenpiper, University of Toronto.
Recruitment status was:  Active, not recruiting
First Posted : March 8, 2016
Last Update Posted : August 24, 2016
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
The Physicians' Services Incorporated Foundation
Canadian Diabetes Association
Information provided by (Responsible Party):
John Sievenpiper, University of Toronto

Brief Summary:
There is an urgent need for stronger evidence to support recommendations for the role of sugars in diabetes and related cardiometabolic diseases. Although large prospective cohort studies have shown a significant positive association of fructose-containing sugars-sweetened beverages with incident obesity, diabetes, heart disease, and stroke, these associations do not appear to hold true for total fructose-containing sugars and other important sources of free fructose-containing sugars such as pure fruit juice, yogurt, or even cakes and sweets. As dietary guidelines have moved away from macronutrient centric recommendations towards more food and dietary-pattern based recommendations, this inconsistency in the data has not been appreciated. There remains a focus on free sugars, in the absence of sufficient information on the role of different food sources of fructose-containing sugars in diabetes and related cardiometabolic diseases. A systematic review and meta-analysis of prospective cohort studies is considered to be the "Gold Standard" of evidence. To provide evidence-based guidance to support the development of public health policy in relation sugars and the primary prevention of diabetes, we will conduct a series of systematic reviews and meta-analyses of the relation of food sources of fructose-containing sugars with incident type 2 diabetes and related cardiometabolic diseases in prospective cohort studies.

Condition or disease Intervention/treatment
Diabetes Mellitus, Type 2 Metabolic Syndrome X Hypertension Cardiovascular Diseases Stroke Gout Other: Fructose-containing Sugars

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Study Type : Observational
Estimated Enrollment : 1 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Relation of Important Food Sources of Sugars With Incident Cardiometabolic Disease: A Series of Systematic Reviews and Meta-analyses to Inform Guidelines, Public Health Policy, and Future Research Design
Study Start Date : September 2015
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Fructose


Intervention Details:
  • Other: Fructose-containing Sugars
    Other Name: fructose, sucrose, high-fructose corn syrup (HFCS)


Primary Outcome Measures :
  1. Type 2 diabetes [ Time Frame: Up to 20 years ]
    Incident type 2 diabetes

  2. Metabolic syndrome [ Time Frame: Up to 20 years ]
    Incident metabolic syndrome

  3. Hypertension [ Time Frame: Up to 20 years ]
    Incident cases of hypertension and those with high blood pressure

  4. Coronary heart disease [ Time Frame: Up to 20 years ]
    Incident coronary heart disease or coronary artery disease

  5. Stroke [ Time Frame: Up to 20 years ]
    Incident stroke

  6. Gout [ Time Frame: Up to 20 years ]
    Incident gout



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:   Yes
Sampling Method:   Probability Sample
Study Population
All individuals, both children and adults, regardless of health status.
Criteria

Prospective cohort studies

Inclusion Criteria

  • Prospective cohort studies or case-cohort studies
  • Duration >= 1 year
  • Assessment of the exposure of fructose-containing sugars or important food sources
  • Ascertainment of viable data by level of exposure

Exclusion Criteria:

  • Ecological, cross-sectional, and retrospective observational studies, clinical trials, and non-human studies
  • Duration < 1 year
  • No assessment of exposures of fructose-containing sugars or important food sources
  • No ascertainment viable clinical outcome data by level of exposure

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): NCT02702375


Locations
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Canada, Ontario
The Toronto 3D (Diet, Digestive tract and Disease) Knowledge Synthesis and Clinical Trials Unit, Clinical Nutrition and Risk Factor Modification Centre, St. Micheal's Hospital
Toronto, Ontario, Canada, M5C 2T2
Sponsors and Collaborators
University of Toronto
Canadian Institutes of Health Research (CIHR)
The Physicians' Services Incorporated Foundation
Canadian Diabetes Association
Investigators
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Principal Investigator: JOHN L SIEVENPIPER, MD, PHD, FRCPC University of Toronto
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: John Sievenpiper, Associate Professor, University of Toronto
ClinicalTrials.gov Identifier: NCT02702375    
Other Study ID Numbers: CIHR-Sugars 2015
First Posted: March 8, 2016    Key Record Dates
Last Update Posted: August 24, 2016
Last Verified: May 2016
Keywords provided by John Sievenpiper, University of Toronto:
Systematic review and meta-analysis
Evidence-based medicine (EBM)
Evidence-based nutrition (EBN)
Clinical practice guidelines
Prospective cohort studies
Dietary sugars
Fructose
Sucrose
High fructose corn syrup
HFCS
Cohort studies
Prospective studies
Diabetes Mellitus
Metabolic syndrome
Coronary heart disease
Stroke
Hypertension
Gout
Additional relevant MeSH terms:
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Hypertension
Cardiovascular Diseases
Diabetes Mellitus
Metabolic Syndrome
Diabetes Mellitus, Type 2
Vascular Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin Resistance
Hyperinsulinism