Interplay of Central and Peripheral Vascular Effects of Insulin in Obesity

Status

Not yet recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07653464

Enrollment

Registered

2026-06-17

Start date

2026-10-01

Completion date

2032-06-01

Last updated

2026-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insulin Resistance, Obesity (BMI>30)

Brief summary

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

Interventions

DRUGhuman insulin

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Amount of muscle sympathetic nerve activity (MSNA)	Change from baseline at minute 30	MSNA burst incidence (bursts/100 heart beats)
Amount of cerebral blood flow	Change from baseline at minute 30	Measured with arterial spin labeling (mL/100 g/min)
Amount of leg blood flow	Change from baseline at minute 30	Measured with Doppler ultrasound (mL/min)

Countries

United States

Contacts

CONTACTJacqueline Limberg

limberglab@missouri.edu573-882-2544

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 29, 2026