AzTrials
AzTrials

Metabolic Syndrome XLPSNCT00954824

Inflammation and the Metabolic Syndrome in Humans

A study testing Endotoxin (LPS) in people with Metabolic Syndrome X, run by University of Pennsylvania 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
Search all trials

Trial summary

People who are overweight are at increased risk of heart disease. Being overweight and having heart disease are linked in that both involve inflammation. Inflammation refers to the body's first line of defense against infection and injury. Read more about this study

Who is it for?
Ages 18 to 40 yearsHealthy volunteers can take part
Conditions the study is for
Metabolic Syndrome X
What is being tested?
Endotoxin (LPS)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteUnited States
Study dates
Aug 2003to Nov 2007
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 18 to 40 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Men and non-pregnant/lactating women between the ages of 18 and 40
  • Subjects must be able to give written informed consent and willing to comply with all study-related procedures.
  • BMI >18 and < 24 and BIA < 15% fat for men, < 25% fat for women, and do not have diagnosis of NCEP metabolic syndrome as defined below, OR
  • BMI > 26 but < 30 and BIA > 15% fat for men, > 25% fat for women, do not have diagnosis of NCEP metabolic syndrome, OR
  • BMI >18 and < 30 and have metabolic syndrome abnormalities as defined below. The modified NCEP Metabolic Syndrome criteria are as follows
  • abdominal obesity, waist circumference: men >= 37 in (94 cm), women >= 31 in (80 cm)
Show all 13Show fewer
  • fasting triglycerides > 150 mg/dL
  • HDL cholesterol < 40 mg/dL for men; HDL cholesterol < 50 mg/dL for women
  • Blood pressure > 130/ >85 mmHg in untreated patients
  • Fasting glucose > 100 mg/dL, but less than 126 mg/dL
  • For inclusion in "metabolic syndrome" group, the following additional criteria must be fulfilled:
  • Three or more of the NCEP criteria defined above. OR
  • Two or more of the NCEP criteria AND TG/HDL ratio > 3.0.

Who cannot join

  • Known atherosclerotic cardiovascular disease, including coronary disease, cerebrovascular disease, or peripheral vascular disease.
  • History of diabetes mellitus.
  • A plasma glucose greater than 200 mg/dL at the 2 hour blood draw of the oral glucose tolerance test.
  • History of a non-skin malignancy within the previous 5 years.
  • Renal insufficiency as defined by creatinine >= 1.5 mg/dl at visit 1 (grade 1 of NIH's Common Toxicity Criteria (CTC), version 2.0, 4/30/99).
  • History of liver disease or ALT, AST, ALK Phosphatase or Gamma GT above normal limits as defined by HUP William Pepper Clinical Laboratory at visit 1.
Show all 25Show fewer
  • Elevated (> 1.5x ULN; grade 1, CTC, 4/30/99) Total Bilirubin or LDH at visit 1.
  • Men who consume > 14 alcoholic drinks per week or > 4 alcoholic drinks per occasion (AMA/NIAAA criteria for "at risk" usage levels).
  • Women who consume > 7 alcoholic drinks per week or > 3 alcoholic drinks per occasion (AMA/NIAAA criteria for "at risk" usage levels).
  • Total white blood cell count below normal limits as defined at HUP William Pepper Clinical Laboratory prior to the baseline visit.
  • Hemoglobin below normal limits (gender specific) as defined at HUP William Pepper Clinical Laboratory prior to the baseline visit.
  • Any medical condition or abnormal laboratory value that is judged clinically significant by an investigator.
  • Any major active rheumatologic, pulmonary, or dermatologic disease or inflammatory condition or minor active infection.
  • History of HIV positive.
  • First degree family history of premature cardiovascular disease event (father or brother if diagnosed at before 55 years of age; mother or sister if diagnosed before 65 years of age).
  • Patients who have undergone any organ transplant.
  • Individuals who currently use tobacco products or have done so in the previous 30 days.
  • Treatment with aspirin, NSAIDs, COX-2 inhibitors, steroids or other immunomodulatory therapy 2 weeks prior to the screening visit
  • Treatment with statins, fibrates or niacin 4 weeks prior to the screening visit.
  • Current daily use of Vitamin C > 1000 mg, Beta carotene > 1000 IU, vitamin A > 5000 IU, vitamin E > 400 IU, and selenium > 200 mcg.
  • Positive urine pregnancy at the screening visit.
  • Participation in another clinical trial within the previous 6 weeks prior to the screening visit.
  • Poorly controlled blood pressure (BP > 160/100) or on any anti-hypertensive medications.
  • For subjects in non-metabolic syndrome groups; a diagnosis of metabolic syndrome using NCEP ATPIII criteria.
  • For subjects in "metabolic syndrome" group; an abnormal Bruce protocol cardiac exercise stress test.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Clinical and Translational Research Center, Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

People who are overweight are at increased risk of heart disease. Being overweight and having heart disease are linked in that both involve inflammation. Inflammation refers to the body's first line of defense against infection and injury. Metabolic changes in cholesterol, triglycerides (fat in the blood) and sugar in the blood caused by inflammation are similar to that in some people who are overweight. The investigators wish to examine the effects of inflammation on these metabolic changes that may lead to heart disease.

Read the detailed description

This study is a single site, open-label, "baseline-controlled" (pre LPS saline period) study examining the pro-atherosclerotic metabolic responses and safety responses to a single administration low-dose (3 ng/kg) endotoxin (LPS) in 20 additional non-metabolic syndrome participants: 10 healthy overweight and 10 healthy lean counterparts (20 non-metabolic syndrome participants were studies in first phase), and 40 subjects with the metabolic syndrome. We are continuing to use an approach whereby "metabolic syndrome" subjects will be recruited to have key metabolic syndrome abnormalities that are sensitive to insulin resistance compared to the non-metabolic syndrome groups, although all of these "metabolic syndrome" subjects may not fulfill traditional NCEP criteria for the syndrome.

Being tested
Endotoxin (LPS)
Medical subject headings
Metabolic Syndrome

What participants receive

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

  • Endotoxin (LPS)Biological

    Also called LPS

    Single administration low-dose (3 ng/kg) endotoxin (LPS).

Study groups in NCT00954824
Study groupRoleWhat they receive
Endotoxin (LPS)ExperimentalSingle administration low-dose (3 ng/kg) endotoxin (LPS).
Receives: Biological: Endotoxin (LPS)

What is being measured

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

  1. The Primary Outcome Measure is Plasma Levels of TNF Alpha.

    Measured: 24 hours

Timeline

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

  1. First posted7 Aug 2009 (estimated)
  2. Study startAug 2003
  3. Primary completionNov 2007
  4. Study completionNov 2007

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
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00954824
Sponsor's protocol ID
706771
Other IDs
1R01HL073278-01
Acronym
LPS
Status last verified
Mar 2017
First submitted
5 Aug 2009
Last updated
30 Mar 2017
Data monitoring committee
No

Publications

  • Anderson PD, Mehta NN, Wolfe ML, Hinkle CC, Pruscino L, Comiskey LL, Tabita-Martinez J, Sellers KF, Rickels MR, Ahima RS, Reilly MP. Innate immunity modulates adipokines in humans. J Clin Endocrinol Metab. 2007 Jun;92(6):2272-9. doi: 10.1210/jc.2006-2545. Epub 2007 Mar 20.

    PubMed 17374708

  • Heffron SP, Parastatidis I, Cuchel M, Wolfe ML, Tadesse MG, Mohler ER 3rd, Ischiropoulos H, Rader DJ, Reilly MP. Inflammation induces fibrinogen nitration in experimental human endotoxemia. Free Radic Biol Med. 2009 Oct 15;47(8):1140-6. doi: 10.1016/j.freeradbiomed.2009.07.025. Epub 2009 Jul 22.

    PubMed 19631267

  • Shah R, Lu Y, Hinkle CC, McGillicuddy FC, Kim R, Hannenhalli S, Cappola TP, Heffron S, Wang X, Mehta NN, Putt M, Reilly MP. Gene profiling of human adipose tissue during evoked inflammation in vivo. Diabetes. 2009 Oct;58(10):2211-9. doi: 10.2337/db09-0256. Epub 2009 Jul 6.

    PubMed 19581417

  • McGillicuddy FC, de la Llera Moya M, Hinkle CC, Joshi MR, Chiquoine EH, Billheimer JT, Rothblat GH, Reilly MP. Inflammation impairs reverse cholesterol transport in vivo. Circulation. 2009 Mar 3;119(8):1135-45. doi: 10.1161/CIRCULATIONAHA.108.810721. Epub 2009 Feb 16.

    PubMed 19221221

  • Badellino KO, Wolfe ML, Reilly MP, Rader DJ. Endothelial lipase is increased in vivo by inflammation in humans. Circulation. 2008 Feb 5;117(5):678-85. doi: 10.1161/CIRCULATIONAHA.107.707349. Epub 2008 Jan 22.

    PubMed 18212282

  • Song WL, Wang M, Ricciotti E, Fries S, Yu Y, Grosser T, Reilly M, Lawson JA, FitzGerald GA. Tetranor PGDM, an abundant urinary metabolite reflects biosynthesis of prostaglandin D2 in mice and humans. J Biol Chem. 2008 Jan 11;283(2):1179-88. doi: 10.1074/jbc.M706839200. Epub 2007 Nov 8.

    PubMed 17993463

  • Lehrke M, Millington SC, Lefterova M, Cumaranatunge RG, Szapary P, Wilensky R, Rader DJ, Lazar MA, Reilly MP. CXCL16 is a marker of inflammation, atherosclerosis, and acute coronary syndromes in humans. J Am Coll Cardiol. 2007 Jan 30;49(4):442-9. doi: 10.1016/j.jacc.2006.09.034. Epub 2007 Jan 12.

    PubMed 17258089

  • Reilly MP, Lehrke M, Wolfe ML, Rohatgi A, Lazar MA, Rader DJ. Resistin is an inflammatory marker of atherosclerosis in humans. Circulation. 2005 Feb 22;111(7):932-9. doi: 10.1161/01.CIR.0000155620.10387.43. Epub 2005 Feb 14.

    PubMed 15710760

  • Lehrke M, Reilly MP, Millington SC, Iqbal N, Rader DJ, Lazar MA. An inflammatory cascade leading to hyperresistinemia in humans. PLoS Med. 2004 Nov;1(2):e45. doi: 10.1371/journal.pmed.0010045. Epub 2004 Nov 30.

    PubMed 15578112

Questions about this trial

What is this clinical trial studying?

A study testing Endotoxin (LPS) in people with Metabolic Syndrome X, run by University of Pennsylvania 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 13 inclusion and 25 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 30 Mar 2017. 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 28 Jan 2016). 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?

The Primary Outcome Measure is Plasma Levels of TNF Alpha. (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 NCT00954824, which also lists 9 linked publications.

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 30 Mar 2017.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in