ET-blockade and Exercise Induced Blood Flow in T2DM

Radboud University Medical Center

Status and phase: Completed; Phase 4

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Placebo; Drug: Bosentan

Study type: Interventional

Funder types: Other

Identifiers

NCT01779596

ET-EX-ACUTE

Details and patient eligibility

About

The purpose of this study is to establish the effect of ET blockade on the acute exercise induced blood flow and endothelial function in subjects with T2DM. We hypothesize that combining ET - blockade with exercise training leads to an acute increase of exercise induced blood flow when compared with exercise alone. We expect that this will lead to an optimization of vascular training effect in T2DM.

Enrollment: 22 patients

Sex: Male

Ages: 40 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Type 2 Diabetes Mellitus (>2 years since diagnosis) OR controls

Exclusion criteria

• <40 years of age
• >65 years of age
• smoking
• cardiovascular disease
• diabetes related manifest vascular complications
• Type 1 Diabetes Mellitus
• use of Glibenclamide
• use of HIV drugs
• use of calcineurin inhibitors
• use of drugs that interfere with CYP3A4 and CYP2C19

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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22 participants in 2 patient groups, including a placebo group

Bosentan

Experimental group

Description:

Single dose of Bosentan (125 mg)

Treatment:

Drug: Bosentan

Placebo

Placebo Comparator group

Description:

Single dose of placebo (125 mg)

Treatment:

Drug: Placebo