Type 2 Diabetes MellitusPhase 4NCT00974272
Effects of Exenatide on Postprandial Hyperlipidemia and Inflammation
A Phase 4 study testing Exenatide and Normal Saline in people with Type 2 Diabetes Mellitus and Impaired Glucose Tolerance, run by Carl T. Hayden VA Medical Center at 1 site in United States.
Trial summary
The primary goal of this study is to determine the acute effects of exenatide on postprandial hypertriglyceridemia. Secondary goals are to determine whether there are additional improvements in postprandial lipids and lipoproteins and whether (by the reduction of hyperglycemia alone or in combination with declines in… Read more about this study
- Who is it for?
- Ages 35 to 70 years
- Conditions the study is for
- Type 2 Diabetes Mellitus, Impaired Glucose Tolerance
- What is being tested?
- Exenatide and Normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2006to Nov 2008
- Phase
- Phase 4
- 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 35 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Recently diagnosed type 2 diabetes (within 3 years) on diet or IGT
- Fasting triglyceride levels >140 and < 400 mg/dl and values varying less than 35% between two screening measurements
- Normal liver function tests and white blood cell count
Who cannot join
- Type 2 Diabetes for > 3 years or HbA1c ≥ 7.5
- Known or suspected Type 1 Diabetes
- Any diabetes medications in the past 3 weeks, TZD in the prior 3 months or prior regular use of insulin
- Creatinine > 2.0 mg/dl or other evidence of active kidney disease
- Hepatic enzyme elevation > 2x normal
- Known Nonalcoholic Fatty Liver Disease
Show all 12Show fewer
- Malabsorption of fat or other nutrients, severe lactose intolerance or other significant gastrointestinal or pancreatic problems
- Recent history of nausea or vomiting
- Acute bacterial or viral illness or evidence of other active infection in the past 4 weeks
- A prior cardiovascular event, stable or unstable angina or other major illness in the past 6 months
- Current regular use of anti-inflammatory medications or antioxidants, including over the counter medications and high dose salicylates (>1 g/day)
- Any lipid lowering therapy in the prior 3 weeks other than a statin medication. Subjects receiving a statin medication must be on a stable dose for at least 2 months prior to participation.
Trial locations and contacts
1 site in 1 country.
About this study
The primary goal of this study is to determine the acute effects of exenatide on postprandial hypertriglyceridemia. Secondary goals are to determine whether there are additional improvements in postprandial lipids and lipoproteins and whether (by the reduction of hyperglycemia alone or in combination with declines in hyperlipidemia) exenatide reduces the pro-inflammatory potential of the postprandial period.
- Being tested
- Exenatide, Normal Saline
- Medical subject headings
- Diabetes Mellitus, Type 2, Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExenatideDrug
Also called Byetta
Single subcutaneous injection (10 μg)
Normal SalineOther
Single subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Exenatide | Experimental | Not described Receives: Drug: Exenatide |
| Placebo | Placebo comparator | Not described Receives: Other: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Triglyceride concentration in serum
Measured: Before and up to 8-hours post-injection
Secondary outcomes (1)
serum or plasma lipoproteins, apolipoproteins and inflammatory markers; endothelial function
Measured: Before and up to 8 hours post-injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2009 (estimated)
- Study startAug 2006
- Primary completionNov 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes MellitusStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carl T. Hayden VA Medical Center
- Sponsor type
- US federal agency
- Investigators
- Peter D Reaven, MD, Principal investigator, Phoenix VA Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00974272
- Sponsor's protocol ID
- PR-015
- Status last verified
- Sep 2009
- First submitted
- 9 Sep 2009
- Last updated
- 10 Sep 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Schwartz EA, Koska J, Mullin MP, Syoufi I, Schwenke DC, Reaven PD. Exenatide suppresses postprandial elevations in lipids and lipoproteins in individuals with impaired glucose tolerance and recent onset type 2 diabetes mellitus. Atherosclerosis. 2010 Sep;212(1):217-22. doi: 10.1016/j.atherosclerosis.2010.05.028. Epub 2010 May 25.
PubMed 20557887Koska J, Schwartz EA, Mullin MP, Schwenke DC, Reaven PD. Improvement of postprandial endothelial function after a single dose of exenatide in individuals with impaired glucose tolerance and recent-onset type 2 diabetes. Diabetes Care. 2010 May;33(5):1028-30. doi: 10.2337/dc09-1961. Epub 2010 Mar 3.
PubMed 20200309
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Exenatide on Postprandial Hyperlipidemia and Inflammation
- ClinicalTrials.gov ID
- NCT00974272
- Acronym / sponsor ID
- PR-015
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Carl T. Hayden VA Medical CenterUS federal agency
- Study start
- Aug 2006
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 10 Sep 2009 (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 primary goal of this study is to determine the acute effects of exenatide on postprandial hypertriglyceridemia. Secondary goals are to determine whether there are additional improvements in postprandial lipids and lipoproteins and whether (by the reduction of hyperglycemia alone or in combination with declines in hyperlipidemia) exenatide reduces the pro-inflammatory potential of the postprandial period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exenatide | Experimental | Drug: Exenatide |
| Placebo | Placebo comparator | Other: Normal Saline |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Recently diagnosed type 2 diabetes (within 3 years) on diet or IGT
- Fasting triglyceride levels >140 and < 400 mg/dl and values varying less than 35% between two screening measurements
- Normal liver function tests and white blood cell count
Key exclusion criteria (12 listed)
- Type 2 Diabetes for > 3 years or HbA1c ≥ 7.5
- Known or suspected Type 1 Diabetes
- Any diabetes medications in the past 3 weeks, TZD in the prior 3 months or prior regular use of insulin
- Creatinine > 2.0 mg/dl or other evidence of active kidney disease
- Hepatic enzyme elevation > 2x normal
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 |
|---|---|---|
| ExenatideAlso: ByettaSingle subcutaneous injection (10 μg) | Drug | Exenatide |
| Normal SalineSingle subcutaneous injection | Other | Placebo |
Primary outcome
Triglyceride concentration in serum
Time frame: Before and up to 8-hours post-injection
1 secondary outcome
serum or plasma lipoproteins, apolipoproteins and inflammatory markers; endothelial function
Time frame: Before and up to 8 hours post-injection
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 10 Sep 2009.
- Derived from this study: PubMed 20557887Schwartz EA, Koska J, Mullin MP, Syoufi I, Schwenke DC, Reaven PD. Exenatide suppresses postprandial elevations in lipids and lipoproteins in individuals with impaired glucose tolerance and recent onset type 2 diabetes mellitus. Atherosclerosis. 2010 Sep;212(1):217-22. doi: 10.1016/j.atherosclerosis.2010.05.028. Epub 2010 May 25.
- Derived from this study: PubMed 20200309Koska J, Schwartz EA, Mullin MP, Schwenke DC, Reaven PD. Improvement of postprandial endothelial function after a single dose of exenatide in individuals with impaired glucose tolerance and recent-onset type 2 diabetes. Diabetes Care. 2010 May;33(5):1028-30. doi: 10.2337/dc09-1961. Epub 2010 Mar 3.
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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.
Peter D Reaven, MD principal investigator
Phoenix VA Healthcare System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Exenatide and Normal Saline in people with Type 2 Diabetes Mellitus and Impaired Glucose Tolerance, run by Carl T. Hayden VA Medical Center 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 3 inclusion and 12 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 10 Sep 2009. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Triglyceride concentration in serum (time frame: Before and up to 8-hours post-injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00974272, which also lists 2 linked publications.
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 10 Sep 2009.