The Acute Effects of Low-dose TNF-α on Glucose Metabolism and β-cell Function in Humans
- Conditions
- Diabetes Type 2
- Registration Number
- NCT01953393
- Lead Sponsor
- Rigshospitalet, Denmark
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- Not specified
- Healthy men
- Age 20-35
- obesity (BMI>25)
- diabetes
- chronic disease
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Beta-cell function 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
1 The Centre of Inflammation and Metabolism, Department of Infectious Diseases and CMRC, Rigshospitalet, Faculty of Health Sciences, University of Copenhagen
🇩🇰Copenhagen N, Denmark