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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01953393
Enrollment
Unknown
Registered
2013-10-01
Start date
2006-04-30
Completion date
2006-10-31
Last updated
2013-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Type 2

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).

Interventions

OTHERLow-dose TNF-alpha

Sponsors

Copenhagen Muscle Research Centre, Rigshospitalet, Copenhagen, Denmark
CollaboratorUNKNOWN
University of Copenhagen
CollaboratorOTHER
Rigshospitalet, Denmark
Lead SponsorOTHER

Study design

Primary purpose
BASIC_SCIENCE

Eligibility

Sex/Gender
MALE
Age
20 Years to 35 Years
Healthy volunteers
Yes

Inclusion criteria

* Healthy men * Age 20-35

Exclusion criteria

* obesity (BMI\>25) * diabetes * chronic disease

Design outcomes

Primary

MeasureTime frameDescription
Beta-cell functionMeasurements 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- IVGTTInsulin 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

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026