Tsigos · Neuroendocrinology 1997 · Dose-escalation interventional study · n=15

Dose effects of recombinant human interleukin-6 on pituitary hormone secretion and energy expenditure.

Cited 226 times in the scientific literature.

Level 4 - case-series / case-control

Small, non-randomized, uncontrolled dose-escalation experimental study in healthy volunteers

PubMed 9258919 · doi:10.1159/000127219 · record verified 2026-08-27

What was done

Fifteen healthy male volunteers received a single subcutaneous injection of recombinant human interleukin-6 (IL-6) across five escalating dose tiers (0.1, 0.3, 1.0, 3.0, and 10.0 mcg/kg body weight; n=3 per dose). Researchers measured resting metabolic rate (RMR) via indirect calorimetry and sampled plasma anterior pituitary hormones and vasopressin half-hourly from baseline through 4 hours post-injection.

What was found

IL-6 was well tolerated without significant adverse effects. Doses of 3.0 and 10.0 mcg/kg induced dose-dependent RMR increases beginning at 60 minutes and peaking between 180 and 240 minutes. ACTH increased dose-dependently at 3.0 and 10.0 mcg/kg, peaking at 150 pg/ml and 255 pg/ml at 60 minutes before returning to baseline by 4 hours; cortisol peaked between 90 and 150 minutes and remained elevated at 4 hours. Growth hormone showed a bell-shaped response peaking at 3.0 mcg/kg (approximately 100-fold stimulation). Prolactin showed a similar bell-shaped increase, TSH decreased progressively over 240 minutes, and gonadotropins showed no clear changes.

Why it matters

This study demonstrates in humans that systemic IL-6 can simultaneously activate the hypothalamic-pituitary-adrenal axis, alter other pituitary hormones, and elevate energy expenditure, supporting a role for IL-6 in immune-endocrine-metabolic cross-talk.

Limits

The sample size was very small (n=3 per dose group, total n=15) and included only healthy men. The study lacked a placebo or vehicle control group, and follow-up was limited to 4 hours post-injection.

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