Effect of Changing Diet on Fasting and Post Fat Load Lipoproteins - Full Text View

Sponsored by:	University of Arkansas
Information provided by:	University of Arkansas
ClinicalTrials.gov Identifier:	NCT00593424

Purpose

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

Condition	Intervention
Hypertriglyceridemia Diabetes Mellitus	Other: Low Fat/High Carbohydrate Other: High Monounsaturated Fat/Low Carbohydrate

MedlinePlus related topics: Diabetes Triglycerides

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Double Blind (Subject, Investigator), Crossover Assignment
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

Further study details as provided by University of Arkansas:

Primary Outcome Measures:

Paired t-test or Wilcoxon signed rank test will be used to evaluate the change in fasting triglycerides with the diets. [ Time Frame: Four times during the study ] [ Designated as safety issue: No ]

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. [ Time Frame: Four times during the study ] [ Designated as safety issue: No ]

Enrollment:	15
Study Start Date:	August 2002
Estimated Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Low Fat/High Carbohydrate	Other: Low Fat/High Carbohydrate Low Fat/High Carbohydrate for 6 week period
2: Active Comparator High Monounsaturated Fat/Low Carbohydrate	Other: High Monounsaturated Fat/Low Carbohydrate High Monounsaturated Fat/Low Carbohydrate for 6 week period

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00593424

Locations

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

Sponsors and Collaborators

University of Arkansas

Investigators

Principal Investigator:

Debra L Simmons, M.D.

UAMS/CAVHS

More Information

Responsible Party:	UAMS/CAVHS ( Debra L. Simmons, M.D. )
Study ID Numbers:	07407
Study First Received:	January 4, 2008
Last Updated:	January 14, 2008
ClinicalTrials.gov Identifier:	NCT00593424
Health Authority:	United States: Institutional Review Board; United States: Federal Government

Study placed in the following topic categories:

Hyperlipidemias
Metabolic Diseases
Hypertriglyceridemia
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Dyslipidemias
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on January 16, 2009