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NCT Number: NCT07653464

Interplay of Central and Peripheral Vascular Effects of Insulin in Obesity

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

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

University of Missouri

Columbia, Missouri, 65211, United States

Location contact

Jacqueline Limberg

CONTACT

[email protected]

573-882-2544

Jacqueline Limberg

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

human insulin

Drug

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

Primary outcomes

  1. Amount of muscle sympathetic nerve activity (MSNA)

    Time frame: Change from baseline at minute 30

    MSNA burst incidence (bursts/100 heart beats)

  2. Amount of cerebral blood flow

    Time frame: Change from baseline at minute 30

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

  3. Amount of leg blood flow

    Time frame: Change from baseline at minute 30

    Measured with Doppler ultrasound (mL/min)

Study contacts

Contact information is provided by the study sponsor or research team.

Jacqueline Limberg

CONTACT

[email protected]

573-882-2544

Sponsors and collaborators

Lead sponsor

University of Missouri-Columbia

Other

Registry information

Important dates

Study start
2026
Primary completion
2031
Study completion
2032
First posted
Jun 17, 2026
Registry last updated
Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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