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Effect of Changing Diet on Fasting and Post Fat Load Lipoproteins

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ClinicalTrials.gov Identifier: NCT00593424
Recruitment Status : Completed
First Posted : January 15, 2008
Last Update Posted : September 2, 2011
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Hypertriglyceridemia Diabetes Mellitus Other: Low Fat/High Carbohydrate Other: High Monounsaturated Fat/Low Carbohydrate Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, 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
Study Start Date : August 2002
Actual Primary Completion Date : November 2005
Actual Study Completion Date : November 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Triglycerides

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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 Measures :
  1. 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 ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT00593424     History of Changes
Other Study ID Numbers: 07407
First Posted: January 15, 2008    Key Record Dates
Last Update Posted: September 2, 2011
Last Verified: September 2011

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