The Suppression of Toll Like Receptors by Insulin

NCT01151605 | Completed Results

• 2 other identifiers: 1934708CR13
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Insulin Resistance

Outcome Measures

Primary Outcomes (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.

  24 hours

Secondary Outcomes (3)

• Change in TLR4 mRNA in MNC

  24 hours

• Change in CD14 Expression in MNC

  24hrs

• Fasting TLR2 mRNA Expression Levels in the 3 Cohorts

  baseline/fasting

Study Arms (3)

obese subjects

EXPERIMENTAL

obese (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

Drug: insulin infusion; Drug: Dextrose infusion; Drug: Saline Infusion

Normal weight subjects

ACTIVE COMPARATOR

Normal weight subjects infused with insulin, dextrose and saline in this specific sequence 1 week apart. Each infusion will continue for up to 24 hr

Drug: insulin infusion; Drug: Dextrose infusion; Drug: Saline Infusion

obese type 2 diabetes subjects

EXPERIMENTAL

obese (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

Drug: insulin infusion; Drug: Dextrose infusion; Drug: Saline Infusion

Interventions

insulin infusion DRUG

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

Also known as: Intravenous regular insulin infusion

Normal weight subjects; obese subjects; obese type 2 diabetes subjects

Dextrose infusion DRUG

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

Also known as: Intravenous dextrose solution infusion

Normal weight subjects; obese subjects; obese type 2 diabetes subjects

Saline Infusion DRUG

Saline will be infused at 100ml/hr

Also known as: normal saline infusion

Normal weight subjects; obese subjects; obese type 2 diabetes subjects

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University at Buffalo: lead
• American Diabetes Association: collaborator

Study Sites (1)

Millard Fillmore Gates Hospital

Buffalo, New York, 14209, United States

Location

MeSH Terms

Conditions

Insulin Resistance

Interventions

Insulin Infusion Systems

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Drug Delivery Systems; Drug Therapy; Therapeutics; Infusion Pumps; Equipment and Supplies; Artificial Organs; Surgical Equipment

Results Point of Contact

• Title: husam ghanim
• Organization: State University of NY at Buffalo

ghanim@bufffalo.edu

7168818924

Study Officials

• Paresh Dandona, MBBS

  The Research foundation of SUNY at Buffalo

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: 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.

Study Record Dates

• First Submitted: June 25, 2010
• First Posted: June 28, 2010
• Study Start: September 1, 2008
• Primary Completion: July 1, 2012
• Study Completion: December 1, 2013
• Last Updated: September 11, 2026
• Results First Posted: September 11, 2026

Record last verified: 2026-08

Locations

US (1)