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

September 24, 2013 updated by: Tobias Ibfelt, Rigshospitalet, Denmark

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen N, Denmark, 2200
        • 1 The Centre of Inflammation and Metabolism, Department of Infectious Diseases and CMRC, Rigshospitalet, Faculty of Health Sciences, University of Copenhagen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Healthy men
  • Age 20-35

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Collaborators

University of Copenhagen
Copenhagen Muscle Research Centre, Rigshospitalet, Copenhagen, Denmark

Investigators

  • Principal Investigator: Christian P Fischer, MD, Rigshospitalet, Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2006

Primary Completion (Actual)

May 1, 2006

Study Completion (Actual)

October 1, 2006

Study Registration Dates

First Submitted

September 13, 2013

First Submitted That Met QC Criteria

September 24, 2013

First Posted (Estimate)

October 1, 2013

Study Record Updates

Last Update Posted (Estimate)

October 1, 2013

Last Update Submitted That Met QC Criteria

September 24, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RH TAL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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