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

Diabetes Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01953393
• Other study ID #: RH TAL
• Status: Completed
• Phase: N/A
• First received: September 13, 2013
• Last updated: September 24, 2013
• Start date: April 2006
• Est. completion date: October 2006

Study information

• Verified date: September 2013
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark, Ministry for Health and Prevention
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: October 2006
• Est. primary completion date: May 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 35 Years

Eligibility

Inclusion Criteria:

• Healthy men

• Age 20-35

Exclusion Criteria:

• obesity (BMI>25)

• diabetes

• chronic disease

Study Design

Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Diabetes Type 2

Intervention

Other:
• Low-dose TNF-alpha

Locations

Country	Name	City	State
Denmark	1 The Centre of Inflammation and Metabolism, Department of Infectious Diseases and CMRC, Rigshospitalet, Faculty of Health Sciences, University of Copenhagen	Copenhagen N

Sponsors (3)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark	Copenhagen Muscle Research Centre, Rigshospitalet, Copenhagen, Denmark, University of Copenhagen

Country where clinical trial is conducted

Denmark, 

References & Publications (1)

Plomgaard P, Fischer CP, Ibfelt T, Pedersen BK, van Hall G. Tumor necrosis factor-alpha modulates human in vivo lipolysis. J Clin Endocrinol Metab. 2008 Feb;93(2):543-9. Epub 2007 Nov 20. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Beta-cell function	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	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