ET-blockade and Exercise-induced Vascular Adaptations in T2DM

Radboud University Medical Center

Status and phase: Completed; Phase 4

Conditions: Type 2 Diabetes Mellitus

Treatments: Behavioral: Exercise; Drug: Bosentan; Drug: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01779609

ET-EX-TRAINING

Details and patient eligibility

About

The purpose of this study is to establish the effect of ET blockade on vascular adaptations during an 8-week exercise program 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: 19 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: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

19 participants in 3 patient groups, including a placebo group

Bosentan + Exercise

Experimental group

Description:

2x/day 62.5 mg Bosentan for 4 weeks alongside 3x/week supervised exercise 2x/day 125 mg Bosentan for 4 weeks alongside 3x/week supervised exercise

Treatment:

Drug: Bosentan

Behavioral: Exercise

Placebo + Exercise

Placebo Comparator group

Description:

2x/day 62.5 mg Placebo for 4 weeks alongside 3x/week supervised exercise 2x/day 125 mg Placebo for 4 weeks alongside 3x/week supervised exercise

Treatment:

Drug: Placebo

Behavioral: Exercise

Exercise

Other group

Description:

3x/week supervised exercise for 8 weeks

Treatment:

Behavioral: Exercise