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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00818935
Recruitment Status : Completed
First Posted : January 8, 2009
Last Update Posted : January 8, 2009
Sponsor:
Information provided by:

Study Description
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.

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

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Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Glycemic Indices of Caribbean Foods and Application in Dietary Lifestyle Intervention for Management of Type 2 Diabetes Mellitus
Study Start Date : June 2004
Primary Completion Date : April 2005
Study Completion Date : April 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Low-Intermediate-Glycemic Index diets Dietary Supplement: Low-Intermediate-Glycemic Index diets
Active Comparator: High GI diet Dietary Supplement: High GI diet


Outcome Measures

Primary Outcome Measures :
  1. Glycated Haemoglobin [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

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): 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

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
First Posted: January 8, 2009    Key Record Dates
Last Update Posted: January 8, 2009
Last Verified: January 2009

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