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NCT00593424 Clinical Trial

Effect of Changing Diet on Fasting and Post Fat Load Lipoproteins

Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00593424
Other study ID # 07407
Secondary ID
Status Completed
Phase N/A
First received January 4, 2008
Last updated September 1, 2011
Start date August 2002
Est. completion date November 2005

Study information
Verified date September 2011
Source University of Arkansas
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review BoardUnited States: Federal Government
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 15
Est. completion date November 2005
Est. primary completion date November 2005
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- Male and female,

- 18 - 75 years of age

- Type 2 diabetes

- Fasting triglycerides 300 -800mg/dL

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

Intervention

Other:
• Low Fat/High Carbohydrate
Low Fat/High Carbohydrate for 6 week period
• High Monounsaturated Fat/Low Carbohydrate
High Monounsaturated Fat/Low Carbohydrate for 6 week period

Locations
Country Name City State
United States Central Arkansas Veterans Healthcare System Little Rock Arkansas

Sponsors (1)
Lead Sponsor Collaborator
University of Arkansas

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 No
Secondary 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 No
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