Effect of Changing Diet on Fasting and Post Fat Load Lipoproteins

Not Applicable

Completed

• Conditions: Hypertriglyceridemia; Diabetes Mellitus
• Interventions: Other: Low Fat/High Carbohydrate; Other: High Monounsaturated Fat/Low Carbohydrate

• Registration Number: NCT00593424
• Lead Sponsor: University of Arkansas

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-08
• Primary Completion: 2005-11
• Study Completion: 2005-11
• Study First Submitted: 2008-01-04
• Study First Submitted QC: 2008-01-14
• Study First Posted: 2008-01-15
• Status Verified: 2011-09
• Last Update Submitted: 2011-09-01
• Last Update Posted: 2011-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	Low Fat/High Carbohydrate	Low Fat/High Carbohydrate
2	High Monounsaturated Fat/Low Carbohydrate	High Monounsaturated Fat/Low Carbohydrate

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Central Arkansas Veterans Healthcare System; 🇺🇸 Little Rock, Arkansas, United States