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Effects of Exenatide on Postprandial Hyperlipidemia and Inflammation

Primary Purpose

Type 2 Diabetes Mellitus, Impaired Glucose Tolerance

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Exenatide

Normal Saline

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus

Eligibility Criteria

35 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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.

Sites / Locations

Phoenix VA Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Exenatide

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Triglyceride concentration in serum

Secondary Outcome Measures

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

Full Information

NCT ID

NCT00974272

First Posted

September 9, 2009

Last Updated

September 9, 2009

Sponsor

Carl T. Hayden VA Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT00974272

Brief Title

Effects of Exenatide on Postprandial Hyperlipidemia and Inflammation

Official Title

Effects of Exenatide on Postprandial Hyperlipidemia and Inflammation

Study Type

Interventional

2. Study Status

Record Verification Date

September 2009

Overall Recruitment Status

Completed

Study Start Date

August 2006 (undefined)

Primary Completion Date

November 2008 (Actual)

Study Completion Date

November 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Carl T. Hayden VA Medical Center

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 2 Diabetes Mellitus, Impaired Glucose Tolerance

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

39 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Exenatide

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Exenatide

Other Intervention Name(s)

Byetta

Intervention Description

Single subcutaneous injection (10 μg)

Intervention Type

Other

Intervention Name(s)

Normal Saline

Intervention Description

Single subcutaneous injection

Primary Outcome Measure Information:

Title

Triglyceride concentration in serum

Time Frame

Before and up to 8-hours post-injection

Secondary Outcome Measure Information:

Title

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

Time Frame

Before and up to 8 hours post-injection

10. Eligibility

Sex

All

Minimum Age & Unit of Time

35 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Peter D Reaven, MD

Organizational Affiliation

Phoenix VA Healthcare System

Official's Role

Principal Investigator

Facility Information:

Facility Name

Phoenix VA Medical Center

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85012

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

20557887

Citation

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.

Results Reference

derived

PubMed Identifier

20200309

Citation

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.

Results Reference

derived

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Effects of Exenatide on Postprandial Hyperlipidemia and Inflammation

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