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Trial record 19 of 559 for:    Cachectin OR Tumor Necrosis Factor-alpha

The Acute Effects of Low-dose TNF-α on Glucose Metabolism and β-cell Function in Humans

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ClinicalTrials.gov Identifier: NCT01953393
Recruitment Status : Completed
First Posted : October 1, 2013
Last Update Posted : October 1, 2013
Sponsor:
Collaborators:
Copenhagen Muscle Research Centre, Rigshospitalet, Copenhagen, Denmark
University of Copenhagen
Information provided by (Responsible Party):
Tobias Ibfelt, Rigshospitalet, Denmark

Brief Summary:

Type 2 diabetes is characterized by increased insulin resistance and impaired insulin secretion. In addition, type 2 diabetes is associated with low grade inflammation indicated by increased levels of proinflammatory cytokines such as TNF-α. TNF-α has previously been shown to impair peripheral insulin signaling in vitro and in vivo. However, it is unclear whether TNF-α may also affect endogenous glucose production (EGP) during fasting and glucose stimulated insulin secretion (GSIS) in vivo.

We hypothesized that low dose TNF-α would increase EGP and attenuate GSIS. Recombinant human TNF-α or placebo was infused in healthy, non-obese and non-diabetic young men (n=10) during a 4-hour basal period followed by an intravenous glucose tolerance test (IVGTT).


Condition or disease Intervention/treatment Phase
Diabetes Type 2 Other: Low-dose TNF-alpha Not Applicable

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Study Type : Interventional  (Clinical Trial)
Primary Purpose: Basic Science
Official Title: The Acute Effects of Low-dose TNF-α on Glucose Metabolism and β-cell Function in Humans
Study Start Date : April 2006
Actual Primary Completion Date : May 2006
Actual Study Completion Date : October 2006

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Beta-cell function [ Time Frame: Measurements at 0h, 1h, 2h, 3h and 4h during basal period. After glucose bolus infusion, measurements every 1 min for the first 30 min and every 3 mins for the next hour. Last measurement 1,5 hours post- IVGTT ]
    Insulin levels (pg/ml) in blood measured continually before and after Intravenous glucose tolerance test. Glucose bolus infused in healthy young men after a 4 hour basal period. Subsequent measurements og insulin and glucose levels in peripheral blood



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Ages Eligible for Study:   20 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy men
  • Age 20-35

Exclusion Criteria:

  • obesity (BMI>25)
  • diabetes
  • chronic disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01953393


Locations
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Denmark
1 The Centre of Inflammation and Metabolism, Department of Infectious Diseases and CMRC, Rigshospitalet, Faculty of Health Sciences, University of Copenhagen
Copenhagen N, Denmark, 2200
Sponsors and Collaborators
Rigshospitalet, Denmark
Copenhagen Muscle Research Centre, Rigshospitalet, Copenhagen, Denmark
University of Copenhagen
Investigators
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Principal Investigator: Christian P Fischer, MD Rigshospitalet, Denmark

Publications of Results:
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Responsible Party: Tobias Ibfelt, MD, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT01953393     History of Changes
Other Study ID Numbers: RH TAL
First Posted: October 1, 2013    Key Record Dates
Last Update Posted: October 1, 2013
Last Verified: September 2013

Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases