Effect of Changing Diet on Fasting and Post Fat Load Lipoproteins

September 1, 2011 updated by: University of Arkansas

Effect of Changing the Diet to Low Fat/High Carbohydrate or High Monounsaturated Fat/Low Carbohydrate on Fasting and Post Fat Load Lipoproteins of Diabetics With Moderate Hypertriglyceridemia

The study examines the effect of two diets on fasting and post fat load lipoproteins of subjects with type 2 diabetes with moderate hypertriglyceridemia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Central Arkansas Veterans Healthcare System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male and female,
  • 18 - 75 years of age
  • Type 2 diabetes
  • Fasting triglycerides 300 -800mg/dL

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Low Fat/High Carbohydrate
Other: Low Fat/High Carbohydrate
Low Fat/High Carbohydrate for 6 week period
Other Names:
  • Diet
Active Comparator: 2
High Monounsaturated Fat/Low Carbohydrate
Other: High Monounsaturated Fat/Low Carbohydrate
High Monounsaturated Fat/Low Carbohydrate for 6 week period
Other Names:
  • Diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Paired t-test or Wilcoxon signed rank test will be used to evaluate the change in fasting triglycerides with the diets.
Time Frame: At the beginning and end of each of the two diet regimens
At the beginning and end of each of the two diet regimens

Secondary Outcome Measures

Outcome Measure
Time Frame
Post-prandial lipids will be evaluated by t-test or Wilcoxon signed rank test for AUC of triglyceride and remnant lipoprotein measured by immunoseparation.
Time Frame: At the beginning and end of each of the two diet regimens
At the beginning and end of each of the two diet regimens

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Arkansas

Investigators

  • Principal Investigator: Debra L Simmons, M.D., UAMS/CAVHS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2002

Primary Completion (Actual)

November 1, 2005

Study Completion (Actual)

November 1, 2005

Study Registration Dates

First Submitted

January 4, 2008

First Submitted That Met QC Criteria

January 14, 2008

First Posted (Estimate)

January 15, 2008

Study Record Updates

Last Update Posted (Estimate)

September 2, 2011

Last Update Submitted That Met QC Criteria

September 1, 2011

Last Verified

September 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07407

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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