NCT01151605

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

June 25, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 28, 2010

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

January 5, 2024

Status Verified

January 1, 2024

Enrollment Period

5 years

First QC Date

June 25, 2010

Last Update Submit

January 1, 2024

Conditions

Insulin Resistance

Outcome Measures

Primary Outcomes (1)

  • The Suppression of Toll Like receptors by Insulin

    Expression of TLR2, TLR4, TLR7 and TLR9 mRNA in mononuclear cells and adipose tissue

    24 hours

Secondary Outcomes (1)

  • TLR expression

    0 hours

Study Arms (3)

obese subjects

EXPERIMENTAL

obese (BMI \>30Kg/m2) subjects infused with insulin dextrose or saline 1 week apart. Each infusion will continue for up to 14 hr

Drug: insulin infusionDrug: Dextrose infusionDrug: Saline Infusion

Normal weight subjects

ACTIVE COMPARATOR

Normal weight subjects infused with insulin dextrose or saline 1 week apart. Each infusion will continue for up to 14 hr

Drug: insulin infusionDrug: Dextrose infusionDrug: Saline Infusion

obese type 2 diabetes subjects

EXPERIMENTAL

obese (BMI \>30Kg/m2) subjects with type 2 diabetes infused with insulin dextrose or saline 1 week apart. Each infusion will continue for up to 14 hr

Drug: insulin infusionDrug: Dextrose infusionDrug: Saline Infusion

Interventions

insulin infusionDRUG

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 subjectsobese subjectsobese type 2 diabetes subjects
Dextrose infusionDRUG

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 subjectsobese subjectsobese type 2 diabetes subjects
Saline InfusionDRUG

Saline will be infused at 100ml/hr

Also known as: normal saline infusion
Normal weight subjectsobese subjectsobese type 2 diabetes subjects

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (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
  • +2 more criteria

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
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Drug Delivery SystemsDrug TherapyTherapeuticsInfusion PumpsEquipment and SuppliesArtificial OrgansSurgical Equipment

Study Officials

  • Paresh Dandona, MBBS

    The Research foundation of SUNY at Buffalo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

June 25, 2010

First Posted

June 28, 2010

Study Start

September 1, 2008

Primary Completion

September 1, 2013

Study Completion

December 1, 2013

Last Updated

January 5, 2024

Record last verified: 2024-01

Locations

US(1)