Interplay of Central and Peripheral Vascular Effects of Insulin in Obesity

Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity of Missouri-Columbia

About this trial

Determine the impact of obesity with insulin resistance on the neurovascular response to brain insulin stimulation.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

18 to 65 years of age

BMI 30-45 kg/m2

Waist circumference ≥102 cm (men) or ≥88 cm (women)

HOMA-IR ≥2.5

Disqualifiers

Pregnancy, breastfeeding

Unable to provide consent

Diabetes or polycystic ovarian syndrome

Known history of cardiovascular disease: heart failure, ischemic heart disease, peripheral artery disease, stroke

Trial design

Design model

Parallel

Treatments tested in this trial

  • human insulin

    Drug

    Participants will be administered human insulin (160 IU) using an intra-nasal device.

Treatment groups

64 Participants
are divided into 2 treatment groups
Group A: Insulin (Doppler)Experimental treatment 1 intervention
Group B: Insulin (MRI)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Amount of muscle sympathetic nerve activity (MSNA)

MSNA burst incidence (bursts/100 heart beats)

Time frame
Change from baseline at minute 30
2

Amount of cerebral blood flow

Measured with arterial spin labeling (mL/100 g/min)

Time frame
Change from baseline at minute 30
3

Amount of leg blood flow

Measured with Doppler ultrasound (mL/min)

Time frame
Change from baseline at minute 30

Secondary outcomes

Other outcomes

Sponsors and contacts

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