Original Data

3-Month Results from Denmark within the Globally Prospective and Observational Study to Evaluate Insulin Detemir Treatment in Type 1 and Type 2 Diabetes: The PREDICTIVE Study

Kjeld Hermansen¹, Per Lund², Kurt Clemmensen³, Leif Breum⁴, Marianne Kleis Moller⁵, Anne Mette Rosenfalck⁶, Erik Christiansen⁷, on behalf of the Danish PREDICTIVE study group

Abstract

PREDICTIVE™ is a large, multi-national, open-label, prospective, observational study to assess the efficacy and safety of insulin detemir in clinical practice. We report 3-month follow-up data from 389 patients with type 1 (n = 312) and type 2 (n = 77) diabetes from Denmark. Insulin detemir improved glycemic control in type 1 patients, with decreases in mean HbA1c (-0.2%, p = 0.0026), fasting glucose (-1.7 mmol/l, p = 0.0033) and within-patient fasting glucose variability (-0.6 mmol/l, p = 0.0472). Non-significant reductions in glycemic parameters were observed in type 2 patients (-0.3% for HbA1c and -2.7 mmol/l for fasting glucose). There was a decrease in mean body weight in both type 1 and type 2 patients (-0.6 kg, p = 0.025 and -1.0 kg, p = 0.0361, respectively). Three patients (0.8%) reported 4 serious adverse drug reactions, including major hypoglycemia. The incidence of major hypoglycemic episodes was reduced from 3.9/patient-years at baseline to 0.4/patient-years at follow-up in type 1 patients (p < 0.0001), and from 1.0 to 0.0/patient-years in type 2 patients (p = 0.1250). In addition, the mean incidence of total and nocturnal hypoglycemic episodes was reduced in both type 1 (-37.4 and -17.7/patient-years, p < 0.0001 for both) and type 2 patients (-17.7 and -7.8/patient-years, p = 0.0012 and p = 0.0020, respectively). The observations from the Danish cohort of the PREDICTIVE study support the overall findings of PREDICTIVE, i.e. insulin detemir improves glycemic control, with a reduced risk of hypoglycemia and no weight gain.

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Association Between Low-Grade Systemic Inflammation and Type 2 Diabetes Mellitus Among Men and Women from the ATTICA Study

Christos Pitsavos¹, Metaxia Tampourlou², Demosthenes B. Panagiotakos², Yannis Skoumas¹, Christina Chrysohoou¹, Tzortzis Nomikos², Christodoulos Stefanadis¹

Abstract

AIM: To investigate the relationship between low-grade inflammation and several glycemic indices in a population-based sample of men and women. METHODS: The ATTICA study is a population-based cohort that randomly enrolled 1514 men and 1528 women (aged >18 years old), stratified by age and gender, from the Greater Athens area, during 2001-2002. Among several characteristics, inflammation markers (high sensitivity C-reactive protein, interleukin-6, tumor necrosis factor-alpha, homocysteine and amyloid A) and glycemic control indices (fasting blood glucose, insulin, HOMA) were measured in the participants. RESULTS: The prevalence of diabetes was 7.8% in men and 6.0% in women. The prevalence of impaired fasting glucose (IFG) was 21% in men and 12% in women. Diabetic subjects had 57% higher mean levels of C-reactive protein (p < 0.001), 22% higher mean levels of interleukin-6 (p < 0.001) and 60% higher levels of tumor necrosis factor-alpha (p < 0.001) compared to non-diabetic subjects. Homocysteine and serum amyloid A levels did not show significant differences among groups. CONCLUSION: Our study supports a positive association between low-grade inflammation and diabetes in a population-based sample of men and women without any evidence of cardiovascular disease, which is independent of demographic, clinical and lifestyle characteristics, including physical activity and dietary factors.

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Long-Term, Moderate Coffee Consumption is Associated With Lower Prevalence of Diabetes Mellitus Among Elderly Non-Tea Drinkers from the Mediterranean Islands (MEDIS Study)

Demosthenes B. Panagiotakos¹, Christos Lionis², Akis Zeimbekis³, Kornilia Makri², Vassiliki Bountziouka¹, Mary Economou¹, Ioanna Vlachou³, Mary Micheli¹, Nikos Tsakountakis², George Metallinos¹, Evangelos Polychronopoulos¹

Abstract

BACKGROUND: We evaluated the association between coffee drinking and the prevalence of type 2 diabetes mellitus in elderly people from the Mediterranean islands. METHODS: During 2005-2007, 500 men and 437 women (aged 65 to 100 years) from the islands of Cyprus (n = 300), Mitilini (n = 142), Samothraki (n = 100), Cephalonia (n = 104), Corfu (n = 160) and Crete (n = 131) participated in the survey. Cardiovascular disease (CVD) risk factors (i.e. hypertension, diabetes, hypercholesterolemia and obesity), as well as behavioral, lifestyle and dietary characteristics were assessed using face-to-face interviews and standard procedures. Among various factors, fasting blood glucose was measured and prevalence of type 2 diabetes mellitus was estimated, according to the established American Diabetes Association (ADA) criteria, while all participants were asked about the frequency of any type of coffee consumption over the last year. RESULTS: Coffee drinking was reported by 84% of the participants, the majority of whom drank boiled coffee. The participants reported that they had consumed coffee for at least 30 years of their life. Data analysis adjusted for various potential confounders, revealed that, compared to non-consumption, the multi-adjusted odds ratio for having diabetes was 0.47 (95%, CI 0.32 to 0.69) for 1-2 cups/day, while it was 1.05 (95%, CI 0.70 to 1.55) for >3 cups/day, after adjusting for various potential confounders. The association of coffee drinking with diabetes was significant only among non-tea drinkers. Increased coffee intake was not associated with diabetes prevalence. CONCLUSION: The data presented suggest that moderate coffee drinking is associated with a lower likelihood of having diabetes, after adjusting for various potential confounders.

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Increased Expression of Monocyte CD11b (Mac-1) in Overweight Recent-Onset Type 1 Diabetic Children

Vincenza Cifarelli¹, Ingrid M. Libman², Angela DeLuca³, Dorothy Becker², Massimo Trucco¹, Patrizia Luppi¹

Abstract

AIM: Compelling evidence implicates inflammation in the pathogenesis of type 1 diabetes mellitus (T1DM) and associated vascular complications. Obesity is also characterized by low-grade systemic inflammation. In this study, we characterized the inflammatory response in diabetes by analyzing the expression of a panel of activation markers on the surface of peripheral blood monocytes in recently-diagnosed T1DM patients. The potential effects of glycemic control and body mass index (BMI) on monocyte phenotype were also investigated. METHODS: Using flow cytometry, we analyzed the expression of CD11b, CD49d, CD54, CD62L and CD64 antigens on monocytes in a cohort of 51 T1DM patients (≤ 2 months after diagnosis). To test whether phenotype change in monocytes was associated with abnormal cellular function, we studied the adhesive capacity of monocytes to human umbilical vein endothelial cells (HUVEC). RESULTS: We found that circulating monocytes from T1DM patients tested at the clinical onset of the disease (i.e. within 1 week of diagnosis) had higher CD11b expression compared to patients analyzed 2 months after diagnosis (p = 0.02). The highest CD11b levels were detected in patients with HbA1c > 8% (p = 0.04 vs. patients with HbA1c < 8%). In T1DM children analyzed 2 months after diagnosis, we found that those who were overweight (BMI ≥ 85th percentile) had higher levels of monocyte activation than those who were not (BMI ≤ 85th percentile) (p = 0.03). CD11b and HbA1c were significantly correlated (correlation coefficient 0.329, p = 0.02). Finally, monocytes from T1DM patients showed higher adhesion to HUVEC compared to controls. CONCLUSIONS: Circulating immune cells from T1DM patients display many aspects of a proinflammatory state, as indicated by primed or activated monocytes. Obesity is an important factor in monocyte activation during diabetes.

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