Effects of Exenatide on Postprandial Hyperlipidemia and Inflammation

C

Carl T. Hayden VA Medical Center

Status and phase

Completed
Phase 4

Conditions

Impaired Glucose Tolerance
Type 2 Diabetes Mellitus

Treatments

Drug: Exenatide
Other: Normal Saline

Study type

Interventional

Funder types

Other U.S. Federal agency

Identifiers

NCT00974272
PR-015

Details and patient eligibility

About

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.

Enrollment

39 patients

Sex

All

Ages

35 to 70 years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Quadruple Blind

39 participants in 2 patient groups, including a placebo group

Exenatide
Experimental group
Treatment:
Drug: Exenatide
Placebo
Placebo Comparator group
Treatment:
Other: Normal Saline

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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