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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Nancy J. Brown, Vanderbilt University

ClinicalTrials.gov Identifier:

NCT00666848

First received: April 23, 2008

Last updated: April 12, 2012

Last verified: April 2012

Results First Received: September 4, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Pharmacodynamics Study; Intervention Model: Crossover Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Basic Science
Conditions:	Metabolic Syndrome Hypertension
Interventions:	Drug: Placebo Drug: Enalapril 5mg Drug: Enalapril 10mg Drug: Sitagliptin

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects received a placebo pill for 5 days prior then arm 1,2,or3 and crossed over to sitagliptin 100mg/day for 5 days prior to arm 1,2,or3. This is a parallel cross over study. 43 subjects were consented. 15 did not meet inclusion criteria. 3 withdrew before randomization.

Reporting Groups

	Description
2 (Enalapril 5mg)	Subjects received Enalapril 5mg on study day and a placebo pill for 5 days prior or subjects received enalapril 5mg on study day and sitagliptin 100mg/day for 5 days prior .
1 (Placebo)	Subjects received a placebo pill on study day and received a placebo pill for 5 days prior or subjects received a Placebo pill on study day and sitagliptin 100mg for 5 days prior.
3 (Enalapril 10mg)	Subjects received Enalapril 10mg on study day and a placebo pill for 5 days prior, or subjects received Enalapril 10mg on study day and sitagliptin 100mg for 5 days prior.

Participant Flow: Overall Study

[1]	15 didn't meet inclusion criteria. 3 withdrew before randomized. 1 withdrawn before randomized.
[2]	finished Aim 2
[3]	finished Aim 1
[4]	finished Aim 3

Baseline Characteristics

Reporting Groups

	Description
2 (Enalapril 5mg)	Subjects received Enalapril 5mg on study day and a placebo pill for 5 days prior or subjects received enalapril 5mg on study day and sitagliptin 100mg/day for 5 days prior .
1 (Placebo)	Subjects received a placebo pill on study day and received a placebo pill for 5 days prior or subjects received a Placebo pill on study day and sitagliptin 100mg for 5 days prior.
3 (Enalapril 10mg)	Subjects received Enalapril 10mg on study day and a placebo pill for 5 days prior, or subjects received Enalapril 10mg on study day and sitagliptin 100mg for 5 days prior.
Total	Total of all reporting groups

Baseline Measures

	2 (Enalapril 5mg)	1 (Placebo)	3 (Enalapril 10mg)	Total
Number of Participants [units: participants]	8	9	7	24
Age [units: participants]
<=18 years	0	0	0	0
Between 18 and 65 years	8	8	7	23
>=65 years	0	1	0	1
Age [units: years] Mean ± Standard Deviation	42 ± 9.8	44 ± 13.9	41 ± 9.1	43 ± 2.2
Gender [units: participants]
Female	3	4	4	11
Male	5	5	3	13
Region of Enrollment [units: participants]
United States	8	9	7	24

Outcome Measures

1. Primary:

Change in MAP During Placebo [ Time Frame: just prior to drug administration and 8 hours after drug administration ]

Show Outcome Measure 1

2. Primary:

Change in MAP During Sitagliptin [ Time Frame: just prior to drug administration and 8 hours following treatment ]

Show Outcome Measure 2

Serious Adverse Events

Other Adverse Events

More Information