Gender-specific associations between insulin resistance, hypertension, and markers of inflammation among adult Saudis with and without diabetes mellitus type 2.

PURPOSE: In view of the important roles of the pro-inflammatory cytokines tumor necrosis factor alpha (TNF-α), interleukin-6 (IL-6) and the acute phase reactant C-reactive protein (CRP) in glucose metabolism and pathogenesis of diabetes mellitus type 2 (DMT2), we assessed gender-specific differences and relative associations of these inflammatory biomarkers to insulin resistance (IR) and risk markers for DMT2. MATERIALS AND METHODS: Serum levels of TNF-α, IL-6 and CRP were determined in 119 clinically diagnosed DMT2 cases, 114 non-DMT2 subjects with IR, and 97 age-matched controls. Fasting blood samples were collected and serum glucose levels, lipid profile, and inflammatory markers were analyzed. RESULTS: In women, a significant association between elevated levels of IL-6 and risk of developing IR [Odds ratio (OR), 4.389, 95 % Confidence Interval (CI) 1.6-11.52, p = 0.004] was found. Significant associations were also found between elevated levels of CRP and risk of hypertension only in female subjects [OR (95% CI) 2.153 (1.04-4.53), p = 0.046]. While, in male subjects, a significant association between elevated levels of TNF-α and risk of developing IR [OR (95% CI) 2.32 (1.09-4.93), p = 0.029] was found. CONCLUSION: The present study showed apparent gender differences in the association of IL-6, CRP, and TNF-a with risks of IR and hypertension, and this could be attributed to sexual dimorphism in fat distribution.

Bioequivalence of Jusline following subcutaneous administration in healthy subjects.

OBJECTIVE: The aim of the current work is to evaluate the pharmacokinetic and pharmacodynamic profile of a new human insulin preparation (jusline) following subcutaneous administration in healthy subjects, and to compare this profile with Humulin insulin. METHODS: 20 healthy male subjects received a single dose of 0.2 U/kg of test (Jusline) or reference insulin (Humulin) during an euglycemic clamp keeping blood sugar constant (90 +/- 5 mg/dl) by changing the glucose infusion rate. Pharmacokinetic and pharmacodynamic measurements were taken from blood measurements of glucose, insulin, and C-peptide levels for tested insulin formulations. RESULTS: The mean values of the individual AUC ratios were well within the 90% confidence interval (100.5% for Regular, 101.9% for NPH, and 100.0% for Premixed Regular/NPH (30/70)). Similarly, Cmax and tmax were within the bioequivalence limit (80 - 125%). The maximum GIR were 10.20 mg/kg/min and 9.72 mg/kg/min for Jusline Regular and Humulin Regular, respectively. The maximum GIR were 7.09 mg/kg/min and 7.91 mg/kg/min for Jusline NPH and Humulin NPH, respectively. The maximum GIR and tGIRmax were 6.39 mg/kg/min and 6.63 mg/kg/ min for Jusline Premixed Regular/NPH (30/70) and Humulin Premixed Regular/NPH (30/70), respectively. Both insulin products produced similar suppression of endogenous C-peptide level (-29.76% to -50.22%). CONCLUSION: The present study demonstrated that after subcutaneous administration, there are no significant differences between Jusline and Humulin to promote peripheral glucose uptake.