Insulin for Obesity

JL
Overseen ByJacqueline Limberg
Age: 18+
Sex: Any
Trial Phase: Phase < 1
Sponsor: University of Missouri-Columbia
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how the brain reacts to insulin in people with obesity and insulin resistance. Researchers aim to understand how insulin affects blood flow in the brain. Participants will receive insulin through a nasal spray to assess its impact. Adults with a BMI over 30 and a large waist may find this trial suitable. As an Early Phase 1 trial, this research seeks to understand how the treatment works in people, offering participants the opportunity to be among the first to experience this innovative approach.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that human insulin is generally safe when administered in various ways. This trial tests a new method of delivering insulin through the nose. Insulin, widely used and FDA-approved for treating diabetes, has a strong safety record. However, specific safety information about this new delivery method remains limited due to the trial's early stage. Early-stage trials primarily assess a treatment's safety, indicating it has passed initial lab tests but requires further testing in people to confirm safety with this new delivery method.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about using human insulin for obesity because it introduces a novel delivery method: an intra-nasal device. Traditional treatments for obesity often include lifestyle changes, medications like orlistat, or even surgical interventions. However, this approach leverages insulin's potential metabolic effects in a new way, potentially offering an easier and less invasive alternative. By delivering insulin directly through the nasal passage, it might enhance brain insulin signaling, which could play a role in regulating appetite and metabolism. This innovative delivery could make insulin a valuable tool in tackling obesity in a more targeted manner.

What evidence suggests that this trial's treatments could be effective for obesity?

This trial will evaluate the effects of administering human insulin using an intra-nasal device for obesity. Research has shown that insulin delivered through a nasal spray might aid in managing obesity. Some studies suggest this method can reduce body fat in men and enhance mood in women with obesity. It also appears to increase the brain's responsiveness to insulin, potentially helping to control overeating. Other research has found that it can lower blood sugar levels and improve insulin utilization in the body. Importantly, various trials have proven intranasal insulin safe, with no major safety issues reported. Participants in this trial will receive insulin through one of two experimental arms: the Insulin (Doppler) arm or the Insulin (MRI) arm.678910

Are You a Good Fit for This Trial?

This trial is for adults aged 18-65 who are either healthy and normal weight (BMI 18-25) or have obesity with insulin resistance (BMI 30-45). Participants must not smoke, be pregnant, have major health issues like heart disease or diabetes, or recent large weight changes.

Inclusion Criteria

HOMA-IR <2
Healthy normal weight adults with BMI 18-25 kg/m2
Individuals with obesity and comorbid insulin resistance (IR) with BMI 30-45 kg/m2
See 4 more

Exclusion Criteria

Body weight change >10% within the last 6 months
Claustrophobia
Current smoking, tobacco, or nicotine use
See 11 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive human insulin (160 IU) administered using an intra-nasal device

1 day
1 visit (in-person)

Follow-up

Participants are monitored for changes in muscle sympathetic nerve activity, cerebral blood flow, and leg blood flow

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • human insulin

Trial Overview

The study tests how the body’s blood vessels respond to insulin in people with and without obesity-related insulin resistance. Human insulin is given to see its effects on brain and body blood flow.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Insulin (MRI)Experimental Treatment1 Intervention
Group II: Insulin (Doppler)Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Missouri-Columbia

Lead Sponsor

Trials
387
Recruited
629,000+

Citations

Intranasal Insulin Therapy for Cognitive Impairment and ... - PMC

Treatment with intranasal insulin prevented the brain morphological abnormalities, white matter loss, and impairments in signaling through survival and synaptic ...

Central effects of acute intranasal insulin on neuroimaging ...

This systematic review synthesized the effects of acute intranasal insulin on neuroimaging, cognitive, and behavioural outcomes reported in 48 studies in adults ...

Intranasal-insulin-Cognitive-Vitality-For- ...

Of the 16 includes trials that assessed cognitive outcomes, 50% of the trials reported a significant effect of intranasal insulin on at least one cognitive ...

Effects of intranasal insulin on endogenous...

In several recent studies in humans, including one by the present authors, intranasal insulin lowered plasma glucose, 6 affected peripheral insulin sensitivity

The effect of intranasal insulin on appetite and mood in ...

IN insulin also improved mood in women with obesity. In both BMI groups, IN insulin increased neural activity in the insula when viewing food ...

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