NCT04045938

Brief Summary

Low glycemic index and low glycemic load diets have been shown to improve glycemic control and cardiometabolic risk factors in randomized controlled trials in people with diabetes and are associated with reduced incidence of diabetes and cardiovascular disease in prospective cohort studies inclusive of people with diabetes. These benefits have been recognized in the most recent updates of the clinical practice guidelines for the management of diabetes from the U.S., Canada, UK, and Australia. The European Association for the Study of Diabetes (EASD) also recommends low-GI/GL diets but has not updated their guidance in 15 years. To support the update of the EASD clinical practice guidelines for nutrition therapy, the investigators conducted a systematic review and meta-analysis of the totality of the available evidence from randomized controlled trials of the effect of low GI/GL dietary patterns on glycemic control and other established cardiometabolic risk factors in individuals with diabetes. The findings generated by this proposed knowledge synthesis will help improve the health of consumers through informing evidence-based guidelines and improving health outcomes by educating healthcare providers and patients, stimulating industry innovation, and guiding future research design.

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 Aug 2019

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

August 1, 2019

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

August 2, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 6, 2019

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

May 17, 2021

Status Verified

May 1, 2021

Enrollment Period

1.8 years

First QC Date

August 2, 2019

Last Update Submit

May 12, 2021

Conditions

Keywords

glycemic indexglycemic loadglycaemic indexglycaemic loadcardiovascular diseasecardiometabolic riskglycemic control

Outcome Measures

Primary Outcomes (1)

  • HbA1c

    Mean Difference

    Up to 20-years

Secondary Outcomes (13)

  • Glycemic control - Fasting blood glucose

    Up to 20-years

  • Glycemic control - Fasting blood insulin

    Up to 20-years

  • Blood lipids - LDL-cholesterol

    Up to 20-years

  • Blood lipids - non-HDL-cholesterol

    Up to 20-years

  • Blood lipids - apo B

    Up to 20-years

  • +8 more secondary outcomes

Interventions

Dietary pattern focused on low glycemic index foods or on a low glycemic load

Also known as: Low Glycaemic Index or Glycaemic Load

Eligibility Criteria

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

Diabetes

You may qualify if:

  • Dietary trials in humans
  • Randomized treatment allocation
  • ≥3 weeks
  • Suitable control (i.e. isocaloric diet that is not low GI or low GL)
  • Viable endpoint data

You may not qualify if:

  • Non-human studies
  • Non-randomized treatment allocation
  • \<3 weeks
  • Lack of a suitable control (i.e. non-isocaloric)
  • No viable endpoint data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Toronto

Toronto, Ontario, M5C2T2, Canada

Location

Related Publications (1)

  • Chiavaroli L, Lee D, Ahmed A, Cheung A, Khan TA, Blanco S, Mejia, Mirrahimi A, Jenkins DJA, Livesey G, Wolever TMS, Rahelic D, Kahleova H, Salas-Salvado J, Kendall CWC, Sievenpiper JL. Effect of low glycaemic index or load dietary patterns on glycaemic control and cardiometabolic risk factors in diabetes: systematic review and meta-analysis of randomised controlled trials. BMJ. 2021 Aug 4;374:n1651. doi: 10.1136/bmj.n1651.

MeSH Terms

Conditions

Diabetes MellitusCardiovascular Diseases

Interventions

Glycemic Load

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Nutritive ValueNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaFood QualityFood TechnologyFood IndustryIndustryTechnology, Industry, and AgriculturePublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 2, 2019

First Posted

August 6, 2019

Study Start

August 1, 2019

Primary Completion

May 31, 2021

Study Completion

June 30, 2021

Last Updated

May 17, 2021

Record last verified: 2021-05

Locations