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Umbrella Review and Updated Systematic Review and Meta-analysis of Pulses/Legumes and Incident Cardiometabolic Diseases

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ClinicalTrials.gov Identifier: NCT03555734
Recruitment Status : Active, not recruiting
First Posted : June 13, 2018
Last Update Posted : June 13, 2018
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
European Foundation for the Study of Diabetes
Information provided by (Responsible Party):
John Sievenpiper, University of Toronto

Brief Summary:
The European Association for the Study of Diabetes (EASD) guidelines have not made any specific recommendations regarding dietary pulses. To update the recommendations, the Diabetes and Nutrition Study Group (DNSG) of the EASD commissioned an umbrella review and updated systematic review and meta-analysis using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach to summarize the available evidence from prospective cohort studies of the association between dietary pulses/legumes and cardiometabolic disease outcomes (incident cardiovascular diseases, diabetes, hypertension and overweight/obesity).

Condition or disease Intervention/treatment
Cardiovascular Diseases Coronary Heart Disease Stroke Diabetes Mellitus, Type 2 Hypertension Obesity Other: Dietary pulses or legumes

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 1 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Association Between Pulses/Legumes and Cardiometabolic Disease Outcomes: An Umbrella Review and Updated Systematic Review and Meta-analysis of Prospective Cohort Studies
Actual Study Start Date : November 21, 2017
Estimated Primary Completion Date : July 31, 2018
Estimated Study Completion Date : July 31, 2018

Intervention Details:
  • Other: Dietary pulses or legumes
    Dietary pulses (dried beans, dried peas, chickpeas, lentils). If no data available specifically for dietary pulses than legumes will be assessed as the exposure (includes pulses, soybeans, peanuts, fresh peas, fresh beans).


Primary Outcome Measures :
  1. Cardiovascular disease (CVD) [ Time Frame: Up to 20 years ]
    Risk ratios for CVD incidence and mortality


Secondary Outcome Measures :
  1. Coronary heat disease (CHD) [ Time Frame: Up to 20 years ]
    Risk ratios for CHD incidence and mortality

  2. Stroke [ Time Frame: Up to 20 years ]
    Risk ratios for stroke incidence and mortality

  3. Diabetes [ Time Frame: Up to 20 years ]
    Risk ratios for diabetes incidence and mortality

  4. Hypertension [ Time Frame: Up to 20 years ]
    Risk ratios for hypertension incidence and mortality

  5. Obesity [ Time Frame: Up to 20 years ]
    Risk ratios for obesity incidence and mortality



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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
Healthy volunteers or those at risk for cardiometabolic diseases
Criteria

Inclusion Criteria:

Umbrella review:

Systematic reviews and meta-analyses of prospective cohort studies assessing the relationship of dietary pulses or legumes with incident cardiometabolic diseases (cardiovascular diseases, diabetes, and hypertension).

Updated systematic review and meta-analysis:

  • Prospective cohorts studies
  • Follow-up duration >=1 year
  • Assessment of the exposure of pulses or legumes
  • Ascertainment of viable data by level of exposure (cardiovascular diseases, diabetes, and hypertension).

Exclusion Criteria:

Umbrella review:

Not a systematic review and meta-analysis of prospective cohort studies that assess' the relationship of dietary pulses or legumes with incident cardiometabolic diseases

Updated systematic review and meta-analysis:

  • Ecological, cross-sectional, retrospective observational studies, clinical trials and non-human studies
  • Duration <1 year
  • No assessment of the exposure of pulses or legumes
  • No ascertainment of viable 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): NCT03555734


Locations
Canada, Ontario
The Toronto 3D (Diet, Digestive tract and Disease) Knowledge Synthesis and Clinical Trials Unit, Clinical Nutrition and Risk Factor Modification Centre, St. Michael's Hospital
Toronto, Ontario, Canada, M5C 2T2
Sponsors and Collaborators
University of Toronto
Canadian Institutes of Health Research (CIHR)
European Foundation for the Study of Diabetes
Investigators
Principal Investigator: John Sievenpiper, MD, PhD University of Toronto

Publications:
Piepoli MF, Hoes AW, Agewall S, Albus C, Brotons C, Catapano AL, Cooney MT, Corrà U, Cosyns B, Deaton C, Graham I, Hall MS, Hobbs FDR, Løchen ML, Löllgen H, Marques-Vidal P, Perk J, Prescott E, Redon J, Richter DJ, Sattar N, Smulders Y, Tiberi M, van der Worp HB, van Dis I, Verschuren WMM, Binno S; ESC Scientific Document Group. 2016 European Guidelines on cardiovascular disease prevention in clinical practice: The Sixth Joint Task Force of the European Society of Cardiology and Other Societies on Cardiovascular Disease Prevention in Clinical Practice (constituted by representatives of 10 societies and by invited experts)Developed with the special contribution of the European Association for Cardiovascular Prevention & Rehabilitation (EACPR). Eur Heart J. 2016 Aug 1;37(29):2315-2381. doi: 10.1093/eurheartj/ehw106. Epub 2016 May 23.

Responsible Party: John Sievenpiper, Associate Professor, MD, PhD, FRCPC, University of Toronto
ClinicalTrials.gov Identifier: NCT03555734     History of Changes
Other Study ID Numbers: DNSG-Pulses
First Posted: June 13, 2018    Key Record Dates
Last Update Posted: June 13, 2018
Last Verified: June 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by John Sievenpiper, University of Toronto:
Pulses (beans, chickpeas, lentils, dry peas)
Legumes
Cardiovascular disease
Coronary heart disease
Stroke
Diabetes
Hypertension
Obesity
Prospective cohort studies
Umbrella review
Systematic review and meta-analysis

Additional relevant MeSH terms:
Diabetes Mellitus
Hypertension
Cardiovascular Diseases
Heart Diseases
Diabetes Mellitus, Type 2
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases