NCT00974272

Brief 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 hyperlipidemia) exenatide reduces the pro-inflammatory potential of the postprandial period.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at below P25 for phase_4 type-2-diabetes-mellitus

Timeline
Completed

Started Aug 2006

Typical duration for phase_4 type-2-diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2006

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 10, 2009

Completed
Last Updated

September 10, 2009

Status Verified

September 1, 2009

Enrollment Period

2.3 years

First QC Date

September 9, 2009

Last Update Submit

September 9, 2009

Conditions

Type 2 Diabetes MellitusImpaired Glucose Tolerance

Outcome Measures

Primary Outcomes (1)

  • Triglyceride concentration in serum

    Before and up to 8-hours post-injection

Secondary Outcomes (1)

  • serum or plasma lipoproteins, apolipoproteins and inflammatory markers; endothelial function

    Before and up to 8 hours post-injection

Study Arms (2)

Exenatide

EXPERIMENTAL
Drug: Exenatide

Placebo

PLACEBO COMPARATOR
Other: Normal Saline

Interventions

ExenatideDRUG

Single subcutaneous injection (10 μg)

Also known as: Byetta
Exenatide
Normal SalineOTHER

Single subcutaneous injection

Placebo

Eligibility Criteria

Age35 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Phoenix VA Medical Center

Phoenix, Arizona, 85012, United States

Location

Related Publications (2)

  • 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.

    PMID: 20557887DERIVED

  • Koska 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.

    PMID: 20200309DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Glucose Intolerance

Interventions

ExenatideSaline Solution

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperglycemia

Intervention Hierarchy (Ancestors)

PeptidesAmino Acids, Peptides, and ProteinsVenomsComplex MixturesToxins, BiologicalBiological FactorsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Peter D Reaven, MD

    Phoenix VA Healthcare System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
FED

Study Record Dates

First Submitted

September 9, 2009

First Posted

September 10, 2009

Study Start

August 1, 2006

Primary Completion

November 1, 2008

Study Completion

November 1, 2008

Last Updated

September 10, 2009

Record last verified: 2009-09

Locations

US(1)