NCT02557022

Brief Summary

A low glycemic index (GI) diet has been associated with improved glycemic control in type 2 diabetes patients and a reduced risk of cardiovascular disease (CVD). Low glycemic load (GL) diets have been associated in cohort studies with a reduction in both diabetes incidence and CVD events, especially in overweight individuals, and have been recommended by the Canadian, American and European diabetes associations. Life style modification trials have shown that reducing body weight in overweight or obese individuals improves obesity-related risk factors. The process of a systematic review combines the results from many studies in order to arrive at a pooled weighted average of the true effect. The investigators propose to conduct a systematic review and meta-analysis of the highest quality evidence from randomized controlled trials to assess the effect of low GI/GL diets on body weight change. The results of this synthesis will inform clinical practice guidelines and lead to better health outcomes through informing healthcare providers and patients, stimulating industry innovation, and guiding future research.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

September 21, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 22, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

August 24, 2016

Status Verified

November 1, 2014

Enrollment Period

2.3 years

First QC Date

September 21, 2015

Last Update Submit

August 22, 2016

Conditions

Body WeightObesityCardiovascular DiseasesDiabetes Mellitus, Type 2

Keywords

Systematic review and meta-analysisEvidence-based medicine (EBM)Evidence-based nutrition (EBN)Clinical practice guidelinesGlycemic indexGlycemic loadBody weightCardiovascular risk factorsCardiovascular disease

Outcome Measures

Primary Outcomes (1)

  • Body weight analysis

    Body weight change by glycemic index and/or glycemic load exposure

    >=3-months (up to 2 years is expected)

Interventions

GI and/or GLOTHER

Randomized controlled trials of equal or more than 12 weeks duration looking at the GI and/or GL of diet as a whole and providing data on body weight

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Varied

You may qualify if:

  • Dietary trials in humans
  • Randomized trials
  • Trials more or equals to 12 weeks duration
  • Suitable control group
  • Body weight data

You may not qualify if:

  • Did not look at glycemic index or glycemic load
  • Co-intervention (i.e. the study is designed in such a way that the effect of glycemic index or glycemic load can not be isolated)
  • Trials looked at glycemic index of specific foods instead of diet as a whole
  • Trials including pregnant or breast feeding women
  • Trials including children
  • Non-human studies
  • Non-randomized trials
  • Trials less than 12 weeks duration
  • Lack of a suitable control group
  • No viable endpoint data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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, M5C 2T2, Canada

Location

Related Publications (6)

  • Mirrahimi A, de Souza RJ, Chiavaroli L, Sievenpiper JL, Beyene J, Hanley AJ, Augustin LS, Kendall CW, Jenkins DJ. Associations of glycemic index and load with coronary heart disease events: a systematic review and meta-analysis of prospective cohorts. J Am Heart Assoc. 2012 Oct;1(5):e000752. doi: 10.1161/JAHA.112.000752. Epub 2012 Oct 25.

    PMID: 23316283BACKGROUND

  • Turner-McGrievy GM, Jenkins DJ, Barnard ND, Cohen J, Gloede L, Green AA. Decreases in dietary glycemic index are related to weight loss among individuals following therapeutic diets for type 2 diabetes. J Nutr. 2011 Aug;141(8):1469-74. doi: 10.3945/jn.111.140921. Epub 2011 Jun 8.

    PMID: 21653575BACKGROUND

  • Jenkins DJ, Srichaikul K, Kendall CW, Sievenpiper JL, Abdulnour S, Mirrahimi A, Meneses C, Nishi S, He X, Lee S, So YT, Esfahani A, Mitchell S, Parker TL, Vidgen E, Josse RG, Leiter LA. The relation of low glycaemic index fruit consumption to glycaemic control and risk factors for coronary heart disease in type 2 diabetes. Diabetologia. 2011 Feb;54(2):271-9. doi: 10.1007/s00125-010-1927-1. Epub 2010 Oct 27.

    PMID: 20978741BACKGROUND

  • Tavani A, Bosetti C, Negri E, Augustin LS, Jenkins DJ, La Vecchia C. Carbohydrates, dietary glycaemic load and glycaemic index, and risk of acute myocardial infarction. Heart. 2003 Jul;89(7):722-6. doi: 10.1136/heart.89.7.722.

    PMID: 12807839BACKGROUND

  • Jenkins DJ, Kendall CW, Augustin LS, Mitchell S, Sahye-Pudaruth S, Blanco Mejia S, Chiavaroli L, Mirrahimi A, Ireland C, Bashyam B, Vidgen E, de Souza RJ, Sievenpiper JL, Coveney J, Leiter LA, Josse RG. Effect of legumes as part of a low glycemic index diet on glycemic control and cardiovascular risk factors in type 2 diabetes mellitus: a randomized controlled trial. Arch Intern Med. 2012 Nov 26;172(21):1653-60. doi: 10.1001/2013.jamainternmed.70.

    PMID: 23089999BACKGROUND

  • Sievenpiper JL, Vuksan V. Glycemic index in the treatment of diabetes: the debate continues. J Am Coll Nutr. 2004 Feb;23(1):1-4. doi: 10.1080/07315724.2004.10719337. No abstract available.

    PMID: 14963048BACKGROUND

MeSH Terms

Conditions

Body WeightObesityCardiovascular DiseasesDiabetes Mellitus, Type 2

Interventions

Equid herpesvirus 1 gl

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesEndocrine System Diseases

Study Officials

  • John L Sievenpiper, MD,PhD,FRCPC

    University of Toronto

    PRINCIPAL INVESTIGATOR

  • David JA Jenkinks, MD,PhD,DSc

    University of Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 21, 2015

First Posted

September 22, 2015

Study Start

September 1, 2014

Primary Completion

December 1, 2016

Study Completion

March 1, 2017

Last Updated

August 24, 2016

Record last verified: 2014-11

Locations

CA(1)