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ObesityPhase 4NCT00636142

Effects of Infliximab on Insulin Sensitivity and Beta Cell Function in Insulin Resistant Human Obesity

A Phase 4 study testing Infliximab in people with Obesity and Insulin Resistance, run by Medical University of Graz at 1 site in Austria.

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

The aim of the study is to test whether neutralizing TNF-alpha with infliximab affects insulin resistance and phenotypical manifestations of the metabolic syndrome as fasting plasma insulin, total body fat, plasma lipid profile or vascular endothelial function in obese male subjects. Read more about this study

Who is it for?
Ages 20 to 50 years, men only
Conditions the study is for
Obesity, Insulin Resistance, Metabolic Syndrome
What is being tested?
Infliximab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
9 participants
Where
1 siteAustria
Study dates
Sep 2005to Sep 2007
Phase
Phase 4
Are there results?
None posted in the registry

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 50 years
  • Men only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Men, 20-50 years
  • BMI 30-35 kg/m2
  • HOMA index > 2.5
  • stable weight (+/- 2 kg) > 3 months
  • Blood pressure>135/85 mmHg (or treated hypertension)
  • Triglycerides>1.7 mmol/l or HDL-cholesterol<1.3 mmol/l
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  • Adequate birth control measures for the duration of the study and should continue such precautions for 6 months after receiving the last infusion.
  • Hemoglobin >= 8.5 g/dL WBC >= 3.5 x 109/L Neutrophils >= 1.5 x 109/L Platelets >= 100 x 109/L SGOT (AST) and AP <3xULN
  • Chest radiograph within 3 months prior to first infusion with no evidence of malignancy, infection or fibrosis.
  • No history of latent or active TB prior to screening. No signs or symptoms suggestive of active TB upon medical history and/or physical examination.
  • No recent close contact with a person with active TB or, if there has been such contact, will be referred to a physician specializing in TB to undergo additional evaluation and, if warranted, receive appropriate treatment for latent TB prior to or simultaneously with the first administration of study agent.
  • Within 1 month prior to the first administration of study agent, either have a negative tuberculin skin test or have a newly identified positive tuberculin skin test during screening in which active TB has been ruled out and for which appropriate treatment for latent TB has been initiated either prior to or simultaneously with the first administration of study agent Have a chest radiograph taken within 3 months prior to the first administration of study agent with no evidence of current active TB or old inactive TB.

Who cannot join

  • Overt Diabetes mellitus
  • Current treatment with angiotensin II antagonists or ACE inhibitors.
  • Treatment indication with statins according to the current NCEP III criteria.
  • Treatment indication with low dose acetylsalicylic acid according to the current AHA guidelines or any other NSAID.
  • Current smokers.
  • Patients with (a history of) an autoimmune disease.
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  • Use of any investigational drug within 1 month prior to screening or within 5 half-lives of the investigational agent, whichever is longer.
  • Treatment with any other therapeutic agent targeted at reducing TNFα within 3 months of screening.
  • Previous administration of infliximab.
  • History of receiving human/murine recombinant products or known allergy to murine products.
  • Serious infections (such as pneumonia or pyelonephritis) in the previous 3 months. Less serious infections (such as acute upper respiratory tract infection [colds] or simple urinary tract infection) need not be considered exclusions at the discretion of the investigator.
  • Documented HIV infection.
  • Active hepatitis- B or antibodies against hepatitis-C
  • History of latent or active granulomatous infection, including TB, histoplasmosis, or coccidioidomycosis, prior to screening.
  • Have or have had a opportunistic infection within 6 months prior to screening.
  • Have current signs or symptoms of severe, progressive or uncontrolled renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, or cerebral disease (including demyelinating diseases such as multiple sclerosis).
  • Concomitant congestive heart failure, including medically controlled asymptomatic patients.
  • Presence of a transplanted organ
  • Malignancy within the past 5 years.
  • History of lymphoproliferative disease including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy of unusual size or location or splenomegaly.
  • Known recent substance abuse (drug or alcohol).
  • Have had a Bacille Calmette-Guerin (BCG) vaccination within 12 months of screening.
  • Have a chest radiograph within 3 months prior to randomization that shows an abnormality suggestive of a malignancy or current active infection, including TB.

Trial locations and contacts

1 site in 1 country.

Austria1 site

  • Department of Internal Medicine, Medical University of Graz

    Graz, 8036

Other trials in Austria

About this study

Official title: A Prospective Trial of Anti-TNF-Alpha Chimeric Monoclonal Antibody (Infliximab, Remicade®) on Insulin Sensitivity, Beta Cell Function and Cardiovascular Risk Profile in Insulin Resistant Human Obesity

The aim of the study is to test whether neutralizing TNF-alpha with infliximab affects insulin resistance and phenotypical manifestations of the metabolic syndrome as fasting plasma insulin, total body fat, plasma lipid profile or vascular endothelial function in obese male subjects.

Read the detailed description

Overweight and obesity are rapidly becoming one of the most pressing health problems. Obese subjects face an increased risk for cardiovascular events that is closely related to a cluster of metabolic disturbances (i.e. insulin resistance, hypertension, dyslipidemia and impaired fibrinolysis), collectively referred to as syndrome X. The actual mechanism underlying development of syndrome X has not been elucidated. Increased TNF-alpha activity has been proposed as a key factor.

The objectives of the study are to test whether neutralizing TNF-alpha with infliximab in obese subjects affects insulin resistance and phenotypical manifestations of the metabolic syndrome such as:

  • fasting plasma insulin
  • ivGTT derived parameters of insulin resistance and beta-cell function
  • total body fat
  • plasma lipid profile
  • vascular endothelial dysfunction
Being tested
Infliximab
Medical subject headings
Obesity, Insulin Resistance, Metabolic Syndrome

What participants receive

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

  • InfliximabBiological

    Also called Remicade, EU/1/99/116/001-003

    5 mg/kg body weight, maximal dose 500 mg; intravenous administration

Study groups in NCT00636142
Study groupRoleWhat they receive
1Active comparatorInfliximab
Receives: Biological: Infliximab
2Placebo comparatorPlacebo
Receives: Biological: Infliximab

What is being measured

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

  1. Change in fasting insulin levels

    Measured: 70 days

Secondary outcomes (1)

  1. Blood pressure; Vascular reactivity; Blood measurements + calculation of the HOMA; Iv-GTT; Body fat mass (DEXA); Safety;

    Measured: 70 days

Timeline

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

  1. First posted14 Mar 2008 (estimated)
  2. Study startSep 2005
  3. Primary completionJun 2007
  4. Study completionSep 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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
9 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00636142
Sponsor's protocol ID
2005-000181-39
Other IDs
2005
Status last verified
Mar 2008
First submitted
11 Mar 2008
Last updated
14 Mar 2008
Results posted
No
Data monitoring committee
Yes

Publications

  • Wascher TC, Lindeman JH, Sourij H, Kooistra T, Pacini G, Roden M. Chronic TNF-alpha neutralization does not improve insulin resistance or endothelial function in "healthy" men with metabolic syndrome. Mol Med. 2011 Mar-Apr;17(3-4):189-93. doi: 10.2119/molmed.2010.00221. Epub 2010 Nov 16.

    PubMed 21103669

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Infliximab in people with Obesity and Insulin Resistance, run by Medical University of Graz at 1 site in Austria.

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 12 inclusion and 23 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 14 Mar 2008. 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 Austria. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Change in fasting insulin levels (time frame: 70 days). 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 NCT00636142, which also lists 1 linked publication.

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 14 Mar 2008.

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