search
Back to results

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

Primary Purpose

Diabetes Type 2

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Low-dose TNF-alpha
Sponsored by
Rigshospitalet, Denmark
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional basic science trial for Diabetes Type 2

Eligibility Criteria

20 Years - 35 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy men
  • Age 20-35

Exclusion Criteria:

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

Sites / Locations

  • 1 The Centre of Inflammation and Metabolism, Department of Infectious Diseases and CMRC, Rigshospitalet, Faculty of Health Sciences, University of Copenhagen

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
September 13, 2013
Last Updated
September 24, 2013
Sponsor
Rigshospitalet, Denmark
Collaborators
Copenhagen Muscle Research Centre, Rigshospitalet, Copenhagen, Denmark, University of Copenhagen
search

1. Study Identification

Unique Protocol Identification Number
NCT01953393
Brief Title
The Acute Effects of Low-dose TNF-α on Glucose Metabolism and β-cell Function in Humans
Official Title
The Acute Effects of Low-dose TNF-α on Glucose Metabolism and β-cell Function in Humans
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
May 2006 (Actual)
Study Completion Date
October 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rigshospitalet, Denmark
Collaborators
Copenhagen Muscle Research Centre, Rigshospitalet, Copenhagen, Denmark, University of Copenhagen

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Type 2

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable

8. Arms, Groups, and Interventions

Intervention Type
Other
Intervention Name(s)
Low-dose TNF-alpha
Primary Outcome Measure Information:
Title
Beta-cell function
Description
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
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

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy men Age 20-35 Exclusion Criteria: obesity (BMI>25) diabetes chronic disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian P Fischer, MD
Organizational Affiliation
Rigshospitalet, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
1 The Centre of Inflammation and Metabolism, Department of Infectious Diseases and CMRC, Rigshospitalet, Faculty of Health Sciences, University of Copenhagen
City
Copenhagen N
ZIP/Postal Code
2200
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
18029463
Citation
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. doi: 10.1210/jc.2007-1761. Epub 2007 Nov 20.
Results Reference
result

Learn more about this trial

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

We'll reach out to this number within 24 hrs