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
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|
|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|
- 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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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01953393
|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|
|Principal Investigator:||Christian P Fischer, MD||Rigshospitalet, Denmark|