Effect of Changing Diet on Fasting and Post Fat Load Lipoproteins
This study has been completed.
Sponsor:
University of Arkansas
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
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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 May 16, 2013