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Low-Intermediate-Glycemic Index Caribbean Foods Versus High Glycemic Index Foods in Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by:
University Hospital of the West Indies
ClinicalTrials.gov Identifier:
NCT00818935
First received: January 6, 2009
Last updated: NA
Last verified: January 2009
History: No changes posted
  Purpose

The purpose of this study is to determine whether low and intermediate GI Caribbean foods are effective in the management of type 2 diabetes.


Condition Intervention
Type 2 Diabetes
Inflammation
Cardiovascular Disease
 Dietary Supplement: Low-Intermediate-Glycemic Index diets
Dietary Supplement: High GI diet

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Glycemic Indices of Caribbean Foods and Application in Dietary Lifestyle Intervention for Management of Type 2 Diabetes Mellitus

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital of the West Indies:

Primary Outcome Measures:
  • Glycated Haemoglobin [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • body weight, homocysteine, C-reactive protein, plasma lipids and lipoproteins, fasting body glucose, insulin, insulin resistance, serum urea, creatinine, C-peptide [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 65
Study Start Date: June 2004
Study Completion Date: April 2005
Primary Completion Date: April 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Low-Intermediate-Glycemic Index diets Dietary Supplement: Low-Intermediate-Glycemic Index diets
Active Comparator: High GI diet Dietary Supplement: High GI diet

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   25 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00818935

Locations
Jamaica
University of the West Indies
Kingston, Jamaica
Sponsors and Collaborators
University Hospital of the West Indies
Investigators
Principal Investigator: Prof Helen N Asemota, PhD Univeristy of the West Indies
  More Information

No publications provided

Responsible Party: Dr. Andrew Wheatley (Principal Investigator), University of the West Indies
ClinicalTrials.gov Identifier: NCT00818935     History of Changes
Other Study ID Numbers: UWI-0012
Study First Received: January 6, 2009
Last Updated: January 6, 2009
Health Authority: Jamaica: Ministry of Health

Additional relevant MeSH terms:
Cardiovascular Diseases
Diabetes Mellitus
Diabetes Mellitus, Type 2
Inflammation
 Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 16, 2013