Clinical trial
Interplay of Central and Peripheral Vascular Effects of Insulin in Obesity
Opening soon · Early Phase 1 · 1 countries · Registry ID NCT07653464
Opening soonEarly Phase 1Interventional
What this study is about
Determine the impact of obesity with insulin resistance on the neurovascular response to brain insulin stimulation.
A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.
Basic eligibility
Age18 Years to 65 Years
SexAll
Healthy volunteersAccepted
ConditionObesity (BMI>30), Insulin Resistance
Full registry criteria
Inclusion Criteria: * 18 to 65 years of age Individuals with obesity and comorbid IR * BMI 30-45 kg/m2 * Waist circumference ≥102 cm (men) or ≥88 cm (women) * HOMA-IR ≥2.5 Healthy normal weight adults * BMI 18-25 kg/m2 * Waist circumference \<94 cm (men) and \<80 cm (women) * HOMA-IR \<2 Exclusion Criteria: * 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 * Nerve/neurologic disease * Uncontrolled hypertension (systolic blood pressure \>180 mmHg and/or diastolic blood pressure \>100 mmHg) * Active cancer (excluding basal cell carcinoma or stage 1 squamous cell carcinoma of the skin) * Current smoking, tobacco, nicotine use * Use of pharmacological therapy for weight loss * Body weight change \>10% within the last 6 months * Adherence to \>150 min/week of moderate-to-vigorous physical activity/exercise * Participation in any other research study or medical procedure involving significant ionizing radiation exposure in the past 12 months * Claustrophobia * Non-MRI compatible metal implants
Treatments and study arms
human insulin
Drug
Participants will be administered human insulin (160 IU) using an intra-nasal device.
Primary outcomes
Amount of muscle sympathetic nerve activity (MSNA)Change from baseline at minute 30
MSNA burst incidence (bursts/100 heart beats)
Amount of cerebral blood flowChange from baseline at minute 30
Measured with arterial spin labeling (mL/100 g/min)
Amount of leg blood flowChange from baseline at minute 30
Measured with Doppler ultrasound (mL/min)
Study locations
1 locations were listed when this page was built. The first 40 are shown.
University of Missouri🇺🇸 Columbia, Missouri, United States
Jacqueline LimbergContact
Jacqueline LimbergPrincipal Investigator