NCT00666848

Effect of Sitagliptin and an ACE Inhibitor on Blood Pressure in Metabolic Syndrome

Effect of Sitagliptin on the Blood Pressure Response to ACE Inhibition in the Metabolic Syndrome

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Vanderbilt University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study will measure the effect of the anti-diabetic agent sitagliptin on blood pressure in individuals with the metabolic syndrome. We will also measure the effect of sitagliptin on blood pressure in people already taking a blood pressure medication called an ACE inhibitor.

Detailed description

The prevalence of metabolic syndrome and Type 2 diabetes mellitus (T2DM) has reached epidemic proportions in developed countries and is closely associated with hypertension. As new oral hypoglycemic agents become available for clinical use, practitioners wishing to treat both hyperglycemia and hypertension will use varieties of combinations of medications. In this setting, understanding interactions and additive effects of these medications becomes essential. Sitagliptin, a selective dipeptidyl peptidase-IV (DPP-4) inhibitor, improves glycemic control in patients with T2DM by decreasing the degradation of the incretin hormones. The incretin hormones glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic peptide (GIP) augment nutrient mediated insulin release. To date there have been two reports of a blood pressure lowering effect of the DPP-4 inhibitor vildagliptin, but no mechanism for this effect has been proposed. Specific Aim 1: To test the hypothesis that the DPP-4 inhibitor sitagliptin lowers blood pressure compared to placebo therapy in subjects with the metabolic syndrome. Specific Aim 2: To test the hypothesis that the DPP-4 inhibitor sitagliptin potentiates the blood pressure response to acute ACE-inhibition.

Conditions

• Metabolic Syndrome
• Hypertension

Interventions

Type	Name	Description
DRUG	Placebo	Enalapril 0mg after 5 days of placebo versus after 5 days sitagliptin 100mg/d
DRUG	Enalapril 5mg	Enalapril 5 mg after 5 days placebo versus after 5 days sitagliptin 100mg/d
DRUG	Enalapril 10mg	Enalapril 10mg after 5 days placebo versus after 5 days sitagliptin 100 mg/d
DRUG	Sitagliptin	Sitagliptin 100mg/day for 5 days crossed over to placebo daily for 5 days prior to arms.

Timeline

• Start date: 2008-03-01
• Primary completion: 2009-08-01
• Completion: 2010-01-01
• First posted: 2008-04-25
• Last updated: 2012-05-11
• Results posted: 2012-05-11

Locations

1 site across 1 country: United States