Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Dyslipidemias
Endocrine System Diseases
Glucose Metabolism Disorders
Hyperlipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on November 25, 2014