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Effect of Changing Diet on Fasting and Post Fat Load Lipoproteins

Primary Purpose

Hypertriglyceridemia, Diabetes Mellitus

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Low Fat/High Carbohydrate
High Monounsaturated Fat/Low Carbohydrate
Sponsored by
University of Arkansas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hypertriglyceridemia

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Sites / Locations

  • Central Arkansas Veterans Healthcare System

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

Low Fat/High Carbohydrate

High Monounsaturated Fat/Low Carbohydrate

Outcomes

Primary Outcome Measures

Paired t-test or Wilcoxon signed rank test will be used to evaluate the change in fasting triglycerides with the diets.

Secondary Outcome Measures

Post-prandial lipids will be evaluated by t-test or Wilcoxon signed rank test for AUC of triglyceride and remnant lipoprotein measured by immunoseparation.

Full Information

First Posted
January 4, 2008
Last Updated
September 1, 2011
Sponsor
University of Arkansas
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1. Study Identification

Unique Protocol Identification Number
NCT00593424
Brief Title
Effect of Changing Diet on Fasting and Post Fat Load Lipoproteins
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
August 2002 (undefined)
Primary Completion Date
November 2005 (Actual)
Study Completion Date
November 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Arkansas

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertriglyceridemia, Diabetes Mellitus

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Low Fat/High Carbohydrate
Arm Title
2
Arm Type
Active Comparator
Arm Description
High Monounsaturated Fat/Low Carbohydrate
Intervention Type
Other
Intervention Name(s)
Low Fat/High Carbohydrate
Other Intervention Name(s)
Diet
Intervention Description
Low Fat/High Carbohydrate for 6 week period
Intervention Type
Other
Intervention Name(s)
High Monounsaturated Fat/Low Carbohydrate
Other Intervention Name(s)
Diet
Intervention Description
High Monounsaturated Fat/Low Carbohydrate for 6 week period
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male and female, 18 - 75 years of age Type 2 diabetes Fasting triglycerides 300 -800mg/dL
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Debra L Simmons, M.D.
Organizational Affiliation
UAMS/CAVHS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Central Arkansas Veterans Healthcare System
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States

12. IPD Sharing Statement

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