Insulin may quiet the immune alarm tied to heart disease

NCT ID NCT01151605

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 11, 2026 ยท Last updated Sep 11, 2026

Summary

Researchers at the University at Buffalo are studying whether insulin can reduce inflammation by suppressing toll-like receptors, which are part of the body's immune alarm system. The trial compares insulin infusion with dextrose and saline infusions in three groups: lean healthy adults, obese adults, and adults with type 2 diabetes. By measuring changes in toll-like receptor genes in blood cells, the team hopes to learn if insulin has anti-inflammatory effects that could help prevent heart disease.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
insulin infusion
What this could lead to
If insulin suppresses toll-like receptors, it could point to new ways to calm the inflammation that drives heart disease in people with insulin resistance.
What could go wrong
This small, early study measures gene activity in blood cells, not heart attacks or strokes. The results may not translate into real health benefits, and insulin infusions carry a risk of low blood sugar.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

42 people

The number who actually took part.

Started

Sep 2008

Finished

Dec 2013

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

20 to 65 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

INCLUSION CRITERIA Lean Group: 1. Age: 20 to 65 years of age inclusive 2. Sex: male or female 3. Normal fasting plasma glucose (65-100 mg/dl) 4. Normal BMI (20-25) Obese Group: 1. Age: 20 to 65 years of age inclusive 2. Sex: male or female 3. Normal fasting plasma glucose (65-100 mg/dl) 4. BMI\> 30 DM Group: 1. Type 2 Diabetes Mellitus 2. Age: 20 to 65 years of age inclusive 3. Sex: male or female 4. BMI \>30 5. Hba1c \< 8% 6. If on statins, angiotensin converting enzyme inhibitor, angiotensin receptor blocker or low dose aspirin, should be on a stable dose for one month. EXCLUSION CRITERIA 1. Pregnancy 2. Congestive heart failure 3. Heart Rate \<50 beats /minute 4. Sick Sinus Syndrome 5. Second or third degree heart block 6. Blood pressure \<80 mm systolic or \> 160/100 mmHg 7. Coronary event or procedure (myocardial infarction, unstable angina, coronary artery bypass surgery or coronary angioplasty) in the previous three months 8. Hepatic disease (transaminase \> 3 times normal) 9. Renal impairment (serum creatinine \> 1.5) 10. History of drug or alcohol abuse within past one year 11. Participation in any other concurrent clinical trial 12. Potassium (K+) values \<3.5 meq/l to \> 5.5 meq/l) 13. Any other life-threatening, non-cardiac disease 14. Use of an investigational agent or therapeutic regimen within 30 days of study 15. Type 2 diabetics on thiazolidinediones and/ or insulin 16. Subjects on steroids, NSAIDS or antioxidants 17. Patients taking exenatide or sitaglipin or loop diuretics 18. Anemia (Hemoglobin level less than 12gm/dl in females and 13gm/dl in males) 19)Allergy to lidocaine

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Insulin resistance are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Millard Fillmore Gates Hospital

    Buffalo, New York, 14209, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.