Comparison of leptin levels in neonates born to mothers with high or low gestational weight gain.

Background Gestational weight gain (GWG) influences both fetal and maternal health. Leptin is a biomarker that may predict the early development of obesity and greater weight gain in childhood. Newborns with higher neonatal weight have been found to have higher leptin levels in umbilical cord blood (UCB). There are few studies that evaluate leptin levels in UCB according to GWG in women with a normal body mass index (BMI). The aim of the present study was to determine whether the levels of leptin in UCB in neonates born to mothers with a high GWG were higher, compared with levels in newborns whose mothers had a low GWG. Methods A cross-sectional analytic study was conducted on 65 primigravidas. They were under 30 years of age, had normal pregestational BMIs, no associated diseases and were classified as having high (n = 22) or low (n = 43) GWG. The neonatal UCB leptin levels were measured and both neonatal and maternal anthropometric evaluations were carried out. The quantitative variables were compared through the Mann-Whitney U test and Student's t test, as appropriate. Results UCB leptin levels were higher in the neonates whose mothers were in the high GWG group, compared with those born to mothers in the low GWG group (7.0 [1.9-11.4] vs. 2.9 [1.2-6.7] ng/mL, p = 0.020). When stratified by sex, that difference was maintained only in male neonates. Conclusions UCB leptin levels were higher in neonates born to mothers with a high GWG, compared with those in newborns whose mothers had a low GWG.

Nalpha-methyl histamine safety and efficacy in migraine prophylaxis: phase III study.

BACKGROUND: The histamine catabolite, Nalpha-methylhistamine, possesses a selective affinity for H3 receptors. For this reason, we considered evaluating the efficacy of this histaminergic H3 agonist in migraine prophylactic treatment. OBJECTIVE: To study the therapeutic potential of the subcutaneous administration of Nalpha-methylhistamine in migraine prophylaxis, in a Phase III clinical pharmacological study. METHODS: Using a controlled double-blind, placebo controlled clinical trial for 12 weeks, 60 patients with migraine, who fit the criteria established by the International Headache Society, were selected. The efficacy of subcutaneous administration of Nalpha-methylhistamine 1 to 3 ng twice a week against placebo was studied, evaluating the outcome of headache intensity, frequency, duration, and analgesic intake. RESULTS: Comparison between the groups treated with placebo (n=30) and Nalpha-methylhistamine (n=30), on data collected for the 4th, 8th and 12th weeks of treatment, revealed that Nalpha-methylhistamine exerted a significant (p<0.0001) reduction (compared to placebo) in intensity, frequency, and duration of migraine attacks, as well as on the use of analgesic intake. No significant (p>0.05) adverse experiences or side effects developed in either group. CONCLUSIONS: The present study provides evidence of the efficacy of Nalpha-methylhistamine, given subcutaneously at doses of 1 to 3 ng twice a week, offering a new therapeutic alternative and laying the clinical and pharmacological groundwork for the use of histaminergic H3-agonists in migraine prophylaxis, which may specifically inhibit the neurogenic edema response involved in migraine pathophysiology.

Nalpha-methylhistamine safety and efficacy in migraine prophylaxis: phase I and phase II studies.

OBJECTIVE: To study the therapeutic potential of the subcutaneous administration of Nalpha-methylhistamine in migraine prophylaxis. BACKGROUND: The histamine catabolite, Nalpha-methylhistamine, possesses a selective affinity for H3 receptors. We consequently considered it viable to conduct a clinical pharmacological study to evaluate the safety and efficacy of this histaminergic H3 agonist in migraine prophylactic treatment, which specifically may inhibit the neurogenic edema response involved in migraine pathophysiology. METHODS: Phase I.-In a clinical trial of 30 healthy volunteers, the effects of the subcutaneous administration of Nalpha-methylhistamine and placebo were studied to assess undesirable symptomatic effects. Phase II.-In a clinical open study, we evaluated the efficacy of Nalpha-methylhistamine in reducing headache intensity, frequency, and duration; and in decreasing analgesic intake in 18 patients with migraine. RESULTS: Phase I.-None of the variables studied showed significant differences (P>.05), and no secondary effects were observed at doses below 10 ng. Phase II.-Nalpha-methylhistamine, at doses of 1 to 3 ng, significantly reduced (P<.0001) the frequency, intensity, and duration of migraine attacks, as well as the need for rescue analgesics. However, at doses greater than 3 ng, patients experienced intense headache. CONCLUSIONS: The present study provides evidence of the safety and efficacy of Nalpha-methylhistamine applied subcutaneously at doses of 1 to 3 ng twice a week.