Insulin may quiet the immune alarm tied to heart disease
NCT ID NCT01151605
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.
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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 Hide 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
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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
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