The Vascular Effects of Exenatide Versus Metformin in Patients With Pre-Diabetes

Phase 4

Completed

Brief Summary: The purpose of this study is to compare the effects of exenatide versus metformin on vascular health with chronic (3-month) therapy and during a 2-hour period following a meal in patients with pre-diabetes. It is predicted that exenatide will improve vascular health to a greater degree compared to metformin.

Recruitment & Eligibility

Inclusion Criteria

Greater than or equal to 18 years old
Impaired glucose tolerance: 2-hr oral glucose tolerance test (OGTT) plasma glucose >140 mg/dL OR impaired fasting glucose: fasting glucose > or = 100 mg/dL OR elevated glycosylated hemoglobin: Hemoglobin A1c > or = 5.7%
Abdominal obesity: waist circumference >102 cm (men) and >88 cm (women)
Stable cardiovascular medication regimen (or other medications known to affect endothelial function) at least 1 month prior to enrollment and throughout the study

Exclusion Criteria

Type 2 diabetes
Current use of glycemic control medications within one month of randomization
Fasting glucose >126 mg/dL
Current use of weight loss medication
Previous weight loss surgery
History of severe gastrointestinal disease
Standard clinical contraindications to exenatide or metformin therapy
Unstable angina
Heart failure
Stroke or coronary artery bypass graft within 3 months of screening
Women who are currently pregnant or planning to become pregnant
Breastfeeding women
Clinically significant liver disease
Creatinine > 1.5 mg/dL
Hepatic function greater than 3 times upper limit of normal
Patients who are mentally incompetent and cannot sign a Patient Informed Consent

Arm && Interventions

Group	Intervention	Description
Exenatide	Exenatide	Subjects were randomlly assigned to treatment arm: Exenatide 10 mcg twice daily vs. Metformin 500 mg twice daily.
Metformin	Metformin	Subjects were randomlly assigned to treatment arm: Exenatide 10 mcg twice daily vs. Metformin 500 mg twice daily.

Primary Outcome Measures

Name	Time	Method
Change in Reactive Hyperemic Index Over the 3-month Treatment Period	Change from baseline to 3 months	Change in reactive hyperemic index over the 3-month treatment period, which is a measure of endothelial (inner lining of blood vessels) function. This is measured as a ratio of post-occlusion blood flow volume versus baseline blood flow volume in fingertips. Higher ratio values are considered indicative of better arterial health.

Secondary Outcome Measures

Name	Time	Method

Locations (2): International Diabetes Center at Park Nicollet
🇺🇸
St. Louis Park, Minnesota, United States
St. Paul Heart Clinic
🇺🇸
St. Paul, Minnesota, United States