HypertriglyceridemiaNCT00593424
Effect of Changing Diet on Fasting and Post Fat Load Lipoproteins
A study testing Low Fat/High Carbohydrate and High Monounsaturated Fat/Low Carbohydrate in people with Hypertriglyceridemia and Diabetes Mellitus, run by University of Arkansas at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hypertriglyceridemia, Diabetes Mellitus
- What is being tested?
- Low Fat/High Carbohydrate and High Monounsaturated Fat/Low Carbohydrate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2002to Nov 2005
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female,
- 18 - 75 years of age
- Type 2 diabetes
- Fasting triglycerides 300 -800mg/dL
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Central Arkansas Veterans Healthcare System
Little Rock, Arkansas, 72205
About this study
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
The study examines the effect of two diets on fasting and post fat load lipoproteins of subjects with type 2 diabetes with moderate hypertriglyceridemia.
- Conditions
- Hypertriglyceridemia, Diabetes Mellitus
- Being tested
- Low Fat/High Carbohydrate, High Monounsaturated Fat/Low Carbohydrate
- Medical subject headings
- Hypertriglyceridemia, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Fat/High CarbohydrateOther
Also called Diet
Low Fat/High Carbohydrate for 6 week period
High Monounsaturated Fat/Low CarbohydrateOther
Also called Diet
High Monounsaturated Fat/Low Carbohydrate for 6 week period
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Low Fat/High Carbohydrate Receives: Other: Low Fat/High Carbohydrate |
| 2 | Active comparator | High Monounsaturated Fat/Low Carbohydrate Receives: Other: High Monounsaturated Fat/Low Carbohydrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Paired t-test or Wilcoxon signed rank test will be used to evaluate the change in fasting triglycerides with the diets.
Measured: At the beginning and end of each of the two diet regimens
Secondary outcomes (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.
Measured: At the beginning and end of each of the two diet regimens
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2008 (estimated)
- Study startAug 2002
- Primary completionNov 2005
- Study completionNov 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertriglyceridemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Debra L Simmons, M.D., Principal investigator, UAMS/CAVHS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00593424
- Sponsor's protocol ID
- 07407
- Status last verified
- Sep 2011
- First submitted
- 4 Jan 2008
- Last updated
- 2 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00593424
- Acronym / sponsor ID
- 07407
- Conditions
- Hypertriglyceridemia, Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Study start
- Aug 2002
- Primary completion
- Nov 2005 (actual)
- Study completion
- Nov 2005 (actual)
- First posted
- 15 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study examines the effect of two diets on fasting and post fat load lipoproteins of subjects with type 2 diabetes with moderate hypertriglyceridemia.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Other: Low Fat/High CarbohydrateLow Fat/High Carbohydrate |
| 2 | Active comparator | Other: High Monounsaturated Fat/Low CarbohydrateHigh Monounsaturated Fat/Low Carbohydrate |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male and female,
- 18 - 75 years of age
- Type 2 diabetes
- Fasting triglycerides 300 -800mg/dL
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low Fat/High CarbohydrateAlso: DietLow Fat/High Carbohydrate for 6 week period | Other | 1 |
| High Monounsaturated Fat/Low CarbohydrateAlso: DietHigh Monounsaturated Fat/Low Carbohydrate for 6 week period | Other | 2 |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2011.
Related trials for Hypertriglyceridemia
Not yet recruiting
Plasma Lipids-Dependent Vitamin E Metabolism During Dynamic Hyperlipidemia
Lipid Metabolism Disorders
Not yet recruitingPhase 4
Effectiveness and Tolerability of a Treat-to-Target Versus Fixed-Dose Statin Strategy in Patients With Atherosclerotic Cardiovascular Disease
Dyslipidemia, Hypercholesterolemia, Hypertriglyceridemia, Stroke (CVA) or TIA
RecruitingPhase 2
A Study of Solbinsiran (LY3561774) in Participants With Severe Hypertriglyceridemia
Severe Hypertriglyceridemia
Recruiting
Pemafibrate for Symptomatic ICAS RCT
Intracranial Atherosclerotic Disease (ICAD), Hypertriglyceridaemia
RecruitingPhase 2
A Study to Assess the Safety, Tolerability and Efficacy of ION775
Hypertriglyceridemia, Severe Hypertriglyceridemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Debra L Simmons, M.D. principal investigator
UAMS/CAVHS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low Fat/High Carbohydrate and High Monounsaturated Fat/Low Carbohydrate in people with Hypertriglyceridemia and Diabetes Mellitus, run by University of Arkansas at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2011.