Low-Intermediate-Glycemic Index Caribbean Foods Versus High Glycemic Index Foods in Type 2 Diabetes
Glycemic Indices of Caribbean Foods and Application in Dietary Lifestyle Intervention for Management of Type 2 Diabetes Mellitus
1 other identifier
interventional
65
1 country
1
Brief Summary
The purpose of this study is to determine whether low and intermediate GI Caribbean foods are effective in the management of type 2 diabetes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable type-2-diabetes
Started Jun 2004
Shorter than P25 for not_applicable type-2-diabetes
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2005
CompletedFirst Submitted
Initial submission to the registry
January 6, 2009
CompletedFirst Posted
Study publicly available on registry
January 8, 2009
CompletedJanuary 8, 2009
January 1, 2009
10 months
January 6, 2009
January 6, 2009
Conditions
Outcome Measures
Primary Outcomes (1)
Glycated Haemoglobin
6 months
Secondary Outcomes (1)
body weight, homocysteine, C-reactive protein, plasma lipids and lipoproteins, fasting body glucose, insulin, insulin resistance, serum urea, creatinine, C-peptide
6 months
Study Arms (2)
Low-Intermediate-Glycemic Index diets
EXPERIMENTALHigh GI diet
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- between the age group of 25-65 years who have been previously clinically diagnosed with type 2 diabetes mellitus.
- Subjects were required to have low activity jobs, for example, clerical jobs
You may not qualify if:
- Individuals with Impaired glucose tolerance (IGT)
- Diabetics who were treated with insulin
- Subjects who were on hypertensive medications
- Individuals who are polycythemic or anemic
- Type 2 diabetics who participate in vigorous exercise Persons with chronic disease other than diabetes making a 3-year survival improbable as well as other medical characteristics that are likely to interfere with their participation in the study, for example, subjects with unbalanced clinical conditions, such as thyroid and liver disease, which could interfere with glucose metabolism; alcoholism or inability to effectively participate in a dietary programme
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of the West Indies
Kingston, Jamaica
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Prof Helen N Asemota, PhD
Univeristy of the West Indies
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
January 6, 2009
First Posted
January 8, 2009
Study Start
June 1, 2004
Primary Completion
April 1, 2005
Study Completion
April 1, 2005
Last Updated
January 8, 2009
Record last verified: 2009-01