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Insulin ResistanceNCT01151605

The Suppression of Toll Like Receptors by Insulin

A study testing insulin infusion, Dextrose infusion and Saline Infusion in people with Insulin Resistance, run by University at Buffalo at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study will help us understand the possible beneficial effects of insulin in inflammation. Inflamamtion is considered to be the cause of atherosclerosis and heart disease. Read more about this study

Who is it for?
Ages 20 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Insulin Resistance
What is being tested?
insulin infusion, Dextrose infusion and Saline Infusion
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
1 siteUnited States
Study dates
Sep 2008to Dec 2013
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Lean Group:
  • Age: 20 to 65 years of age inclusive
  • Sex: male or female
  • Normal fasting plasma glucose (65-100 mg/dl)
  • Normal BMI (20-25)
  • Obese Group:
Show all 17Show fewer
  • Age: 20 to 65 years of age inclusive
  • Sex: male or female
  • Normal fasting plasma glucose (65-100 mg/dl)
  • BMI> 30
  • DM Group:
  • Type 2 Diabetes Mellitus
  • Age: 20 to 65 years of age inclusive
  • Sex: male or female
  • BMI >30
  • Hba1c < 8%
  • If on statins, angiotensin converting enzyme inhibitor, angiotensin receptor blocker or low dose aspirin, should be on a stable dose for one month.

Who cannot join

  • Pregnancy
  • Congestive heart failure
  • Heart Rate <50 beats /minute
  • Sick Sinus Syndrome
  • Second or third degree heart block
  • Blood pressure <80 mm systolic or > 160/100 mmHg
Show all 18Show fewer
  • Coronary event or procedure (myocardial infarction, unstable angina, coronary artery bypass surgery or coronary angioplasty) in the previous three months
  • Hepatic disease (transaminase > 3 times normal)
  • Renal impairment (serum creatinine > 1.5)
  • History of drug or alcohol abuse within past one year
  • Participation in any other concurrent clinical trial
  • Potassium (K+) values <3.5 meq/l to > 5.5 meq/l)
  • Any other life-threatening, non-cardiac disease
  • Use of an investigational agent or therapeutic regimen within 30 days of study
  • Type 2 diabetics on thiazolidinediones and/ or insulin
  • Subjects on steroids, NSAIDS or antioxidants
  • Patients taking exenatide or sitaglipin or loop diuretics
  • Anemia (Hemoglobin level less than 12gm/dl in females and 13gm/dl in males) 19)Allergy to lidocaine

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Millard Fillmore Gates Hospital

    Buffalo, New York, 14209

Other trials in United States

About this study

This study will help us understand the possible beneficial effects of insulin in inflammation. Inflamamtion is considered to be the cause of atherosclerosis and heart disease.

Read the detailed description

Obesity and type 2 diabetes are major health problems in the United States and the world. Both conditions are characterized by increased inflammation and oxidative stress and are associated with increased risk of cardiovascular disease.

Our previous work shows that insulin exerts a prompt and powerful anti-inflammatory effect, on circulating blood cells and in plasma in healthy subjects and in critically ill patients.

Toll like receptors (TLRs) recognize bacterial and viral products like endotoxin and viruses and are major determinants of the inflammatory response against foreign pathogens. In view of the recent data showing that TLRs recognize a range of molecules and proteins that are not of pathogenic source like saturated lipids and that TLRs are involved in the pathogenesis of atherosclerosis which leads to cardiovascular disease and insulin resistance which leads to type 2 diabetes (DM) we hypothesized that insulin infusion suppresses TLRs expression.

Our preliminary data show that insulin infusion for 4 hours reduces the levels of many TLRs and thus might protect from inflammation induced conditions We therefore propose to investigate, in more detail, the effect of infusing different doses of insulin on TLRs mRNA and protein levels and its activity in obese and DM subjects over a longer infusion period and a larger number of subjects in circulating white blood cells and in fat tissue. Also we will be comparing the baseline levels of TLRs and TLRs related proteins as well as their modulation by insulin between normal, obese and DM subjects.

Being tested
insulin infusion, Dextrose infusion, Saline Infusion
Medical subject headings
Insulin Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • insulin infusionDrug

    Also called Intravenous regular insulin infusion

    insulin to be infused at 3.5 units/hour along with Dextrose 12.5% at a rate to achieve blood glucose levels between 80-120mg/dl

  • Dextrose infusionDrug

    Also called Intravenous dextrose solution infusion

    Dextrose 12.5% will be infused at a rate to maintain blood glucose level 80-120mg/dl

  • Saline InfusionDrug

    Also called normal saline infusion

    Saline will be infused at 100ml/hr

Study groups in NCT01151605
Study groupRoleWhat they receive
obese subjectsExperimentalobese (BMI >30Kg/m2) subjects infused with insulin, dextrose and saline in this specific sequence 1 week apart. Each infusion will continue for up to 24 hr
Receives: Drug: insulin infusion; Drug: Dextrose infusion; Drug: Saline Infusion
Normal weight subjectsActive comparatorNormal weight subjects infused with insulin, dextrose and saline in this specific sequence 1 week apart. Each infusion will continue for up to 24 hr
Receives: Drug: insulin infusion; Drug: Dextrose infusion; Drug: Saline Infusion
obese type 2 diabetes subjectsExperimentalobese (BMI >30Kg/m2) subjects with type 2 diabetes infused with insulin, dextrose and saline in this specific sequence 1 week apart. Each infusion will continue for up to 24 hr
Receives: Drug: insulin infusion; Drug: Dextrose infusion; Drug: Saline Infusion

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Suppression of Toll Like Receptor (TLR) 2 mRNA by Insulin

    percent change from baseline (0hrs) in TLR2 mRNA in mononuclear cells (MNC) following up to 24 hrs of 3.5U/hr insulin infusion (II) adjusted to the similar average change following up to 24hr infusion of dextrose (DI) and saline (SI) control groups. The correction is calculated as follows: Corrected percent change from baseline following II= change from baseline following II - (average change from baseline following DI and SI)*100. Changes from baseline are calculated as: (expression at 24hrs-expression at 0hr)/expression at 0hr.

    Measured: 24 hours

Secondary outcomes (3)

  1. Change in TLR4 mRNA in MNC

    percent change from baseline (0hrs) in TLR4 mRNA in mononuclear cells (MNC) following up to 24 hrs of 3.5U/hr insulin infusion (II) adjusted to the same change following up to 24hr infusion of dextrose (DI) and saline (SI) control groups in this order. The correction is conducted as follows: Corrected percent change from baseline following II= change from baseline following II - (average change from baseline following DI and SI)*100. Changes from baseline are calculated as: (expression at 24hrs-expression at 0hr)/expression at 0hr.

    2- For each PCR measurement of specific target gene, relative expression of 3 housekeeping genes (beta-actin, ubiquitin C and cyclophilin A) from the same cDNA is assessed, and normalization factor (based on the 3 genes) is calculated and entered into PCR software to automatically adjust/normalize target gene expression

    Measured: 24 hours

  2. Change in CD14 Expression in MNC

    percent change from baseline (0hrs) in CD14 mRNA in mononuclear cells (MNC) following up to 24 hrs of 3.5U/hr insulin infusion (II) adjusted to the similar average change following up to 24hr infusion of dextrose (DI) and saline (SI) control groups in this specific order. The correction is conducted as follows: Corrected percent change from baseline following II= change from baseline following II - (average change from baseline following DI and SI)*100. Changes from baseline are calculated as: (expression at 24hrs-expression at 0hr)/expression at 0hr. For each PCR measurement of specific target gene, relative expression of 3 housekeeping genes (beta-actin, ubiquitin C and cyclophilin A) from the same cDNA is assessed, and normalization factor (based on the 3 genes) is calculated and entered into PCR software to automatically adjust/normalize target gene expression.

    Measured: 24hrs

  3. Fasting TLR2 mRNA Expression Levels in the 3 Cohorts

    Comparison of TLR2 mRNA expression in MNC in fasting condition. Fasting TLR2 mRNA expression is measured using real-time PCR at baselines of the 3 visits (II, DI, SI visits) is averaged and reported as arbitrary units. For each PCR measurement of specific target gene, relative expression of 3 housekeeping genes (beta-actin, ubiquitin C and cyclophilin A) from the same cDNA is assessed, and normalization factor (based on the 3 genes) is calculated and entered into PCR software to automatically adjust/normalize target gene expression.

    Measured: baseline/fasting

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jun 2010 (estimated)
  2. Study startSep 2008
  3. Primary completionJul 2012
  4. Study completionDec 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
All subjects in each cohort (normal weight, obese and obese with type 2 diabetes) received the 3 interventions (insulin, followed by dextrose, and then Saline) in a fixed sequence.
Masking
None (open label)
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01151605
Sponsor's protocol ID
1934
Other IDs
708CR13
Status last verified
Aug 2026
First submitted
25 Jun 2010
Last updated
11 Sep 2026
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing insulin infusion, Dextrose infusion and Saline Infusion in people with Insulin Resistance, run by University at Buffalo at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Suppression of Toll Like Receptor (TLR) 2 mRNA by Insulin (time frame: 24 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01151605.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.

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