Trial Outcomes & Findings for Metabolic Effects of Antihypertensive Drugs on People With Metabolic Syndrome (The MEAD Study) (NCT NCT00887510)

Results Overview

Comparing the change in OGTT AUC rand 1 visit4-visit 3 with rand 2 visit 3-2. This allows for understanding the effects of addition of trandolapril to 12 weeks of HCTZ compared with addition of HCTZ to 12 weeks of trandolapril. This is the primary outcome of the study.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

24 participants

Primary outcome timeframe

OGTT AUC measured over 120 minutes after receiving study intervention for 18-24 weeks.

Results posted on

2014-06-17

Participant Flow

Patients were enrolled from the University of Florida Shands healthcare system between May 2007 and June 2009.

24 participants recruited; 24 randomized, 61 excluded (61 did not meet inclusion criteria)

Participant milestones

Participant milestones
Measure	Thiazide First Participants will receive 25 mg of hydrochlorothiazide (HCTZ) each day for 6 weeks, followed by 25 mg of HCTZ every day plus 4 mg of trandolapril each day for 6 weeks, followed by 4 mg trandolapril each day for 6 weeks.	Trandolapril First Participants will receive 4 mg of trandolapril each day for 6 weeks, followed by 4 mg of trandolapril for 6 weeks plus 25 mg of HCTZ each day for 6 weeks, followed by 25 mg of HCTZ each day for 6 weeks.
Overall Study STARTED	12	12
Overall Study COMPLETED	12	12
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Metabolic Effects of Antihypertensive Drugs on People With Metabolic Syndrome (The MEAD Study)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Thiazide First n=12 Participants Participants will receive 25 mg of hydrochlorothiazide (HCTZ) each day for 6 weeks, followed by 25 mg of HCTZ every day plus 4 mg of trandolapril each day for 6 weeks, followed by 4 mg trandolapril each day for 6 weeks.	Trandolapril First n=12 Participants Participants will receive 4 mg of trandolapril each day for 6 weeks, followed by 4 mg of trandolapril for 6 weeks plus 25 mg of HCTZ each day for 6 weeks, followed by 25 mg of HCTZ each day for 6 weeks.	Total n=24 Participants Total of all reporting groups
Age, Continuous	43.4 years STANDARD_DEVIATION 9.6 • n=5 Participants	45.7 years STANDARD_DEVIATION 10.6 • n=7 Participants	44.5 years STANDARD_DEVIATION 10.1 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants	12 participants n=7 Participants	24 participants n=5 Participants

PRIMARY outcome

Timeframe: OGTT AUC measured over 120 minutes after receiving study intervention for 18-24 weeks.

Comparing the change in OGTT AUC rand 1 visit4-visit 3 with rand 2 visit 3-2. This allows for understanding the effects of addition of trandolapril to 12 weeks of HCTZ compared with addition of HCTZ to 12 weeks of trandolapril. This is the primary outcome of the study.

Outcome measures

Outcome measures
Measure	Thiazide First n=12 Participants Participants will receive 25 mg of hydrochlorothiazide (HCTZ) each day for 6 weeks, followed by 25 mg of HCTZ every day plus 4 mg of trandolapril each day for 6 weeks, followed by 4 mg trandolapril each day for 6 weeks.	Trandolapril First n=12 Participants Participants will receive 4 mg of trandolapril each day for 6 weeks, followed by 4 mg of trandolapril for 6 weeks plus 25 mg of HCTZ each day for 6 weeks, followed by 25 mg of HCTZ each day for 6 weeks.
Change in Oral Glucose Tolerance Test (OGTT) Area Under Curve (AUC) After Addition of Trandolapril to Hydrochlorothiazide (HCTZ) Compared With Change in OGTT AUC After Addition of HCTZ to Trandolapril	-472 minutes*mg/dl Standard Deviation 2064	1571 minutes*mg/dl Standard Deviation 2256

SECONDARY outcome

Timeframe: Over the course of 18 weeks

Comparing the change in adiponectin: rand 1 visit4-visit 3 with rand 2 visit 3-2. This allows for understanding the effects of addition of trandolapril to 12 weeks of HCTZ compared with addition of HCTZ to 12 weeks of trandolapril.

Outcome measures

Outcome measures
Measure	Thiazide First n=12 Participants Participants will receive 25 mg of hydrochlorothiazide (HCTZ) each day for 6 weeks, followed by 25 mg of HCTZ every day plus 4 mg of trandolapril each day for 6 weeks, followed by 4 mg trandolapril each day for 6 weeks.	Trandolapril First n=12 Participants Participants will receive 4 mg of trandolapril each day for 6 weeks, followed by 4 mg of trandolapril for 6 weeks plus 25 mg of HCTZ each day for 6 weeks, followed by 25 mg of HCTZ each day for 6 weeks.
Change in Total Adiponectin Level After Addition of Trandolapril to HCTZ Compared With Change in Adiponectin After Addition of HCTZ to Trandolapril	-1.36 mcg/ml Standard Deviation 0.96	0.42 mcg/ml Standard Deviation 1.11

Adverse Events

Thiazide First

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Trandolapril First

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Thiazide First n=12 participants at risk Participants will receive 25 mg of hydrochlorothiazide (HCTZ) each day for 6 weeks, followed by 25 mg of HCTZ every day plus 4 mg of trandolapril each day for 6 weeks, followed by 4 mg trandolapril each day for 6 weeks.	Trandolapril First n=12 participants at risk Participants will receive 4 mg of trandolapril each day for 6 weeks, followed by 4 mg of trandolapril for 6 weeks plus 25 mg of HCTZ each day for 6 weeks, followed by 25 mg of HCTZ each day for 6 weeks.
Skin and subcutaneous tissue disorders Sulfuric acid splatter	8.3% 1/12 • Number of events 1	0.00% 0/12

Other adverse events

Adverse event data not reported

Additional Information

Rhonda M Cooper-DeHoff

University of Florida

Phone: 352 273-6184

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place