Effect of Changing Diet on Fasting and Post Fat Load Lipoproteins

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Arkansas
ClinicalTrials.gov Identifier:
NCT00593424
First received: January 4, 2008
Last updated: September 1, 2011
Last verified: September 2011
  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

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

Resource links provided by NLM:


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: At the beginning and end of each of the two diet regimens ] [ 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: At the beginning and end of each of the two diet regimens ] [ Designated as safety issue: No ]

Enrollment: 15
Study Start Date: August 2002
Study Completion Date: November 2005
Primary Completion Date: November 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Low Fat/High Carbohydrate
Other: Low Fat/High Carbohydrate
Low Fat/High Carbohydrate for 6 week period
Other Name: 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 Name: Diet

  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

No publications provided

Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT00593424     History of Changes
Other Study ID Numbers: 07407
Study First Received: January 4, 2008
Last Updated: September 1, 2011
Health Authority: United States: Institutional Review Board
United States: Federal Government

Additional relevant MeSH terms:
Diabetes Mellitus
Hypertriglyceridemia
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on April 17, 2014