NCT07874945

Brief Summary

Successful completion of this project will advance our understanding of the role sympathetic nervous system overactivity plays in driving skeletal muscle malperfusion during hyperinsulinemia and consequently impaired glucose uptake in obesity.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P75+ for early_phase_1

Timeline
67mo left

Started Dec 2026

Longer than P75 for early_phase_1

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 4, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 15, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2026

Expected
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2031

1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2032

Last Updated

October 15, 2026

Status Verified

October 1, 2026

Enrollment Period

4.5 years

First QC Date

October 4, 2026

Last Update Submit

October 8, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Forearm blood flow

    5-minute resting average

Study Arms (2)

Healthy normal weight adults

EXPERIMENTAL

Healthy normal weight adults

Drug: human insulin

Individuals with obesity and comorbid IR

EXPERIMENTAL

Individuals with obesity and comorbid insulin resistance

Drug: human insulin

Interventions

Participants will be administered intra-arterial insulin

Healthy normal weight adultsIndividuals with obesity and comorbid IR

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- 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

You may not qualify if:

  • 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
  • Sensitivity to lidocaine
  • Increased risk of bleeding, pro-coagulant disorders, clotting disorders, anticoagulation therapy
  • History of hypersensitivity to nitrates

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

ObesityInsulin Resistance

Interventions

Insulin

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsHyperinsulinismGlucose Metabolism DisordersMetabolic Diseases

Intervention Hierarchy (Ancestors)

ProinsulinInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Central Study Contacts

Jacqueline Limberg

CONTACT

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 4, 2026

First Posted

October 15, 2026

Study Start (Estimated)

December 1, 2026

Primary Completion (Estimated)

June 1, 2031

Study Completion (Estimated)

June 1, 2032

Last Updated

October 15, 2026

Record last verified: 2026-10