The impact of lockdown caused by the COVID-19 pandemic on glycemic control in patients with diabetes.

PURPOSE: The aim the study was to assess the impact of the lockdown due to COVID-19 on diabetes control. METHODS: The HbA1c value from a pre-lockdown visit (V1) from patients with diabetes was compared to the lockdown visit one (V2) after 3-5 months of its duration. Additional information on how the HbA1c changed and which variables can modify HbA1c during lockdown was also studied. RESULTS: Records from 65 patients (type 2 diabetes -96,9%) were eligible and revealed that: HbA1c was at the target in 60% of the patients at V2 compared to 40% at V1; HbA1c decreased and normalized in 19, but worsened in 4 participants during the lockdown. No impact on HbA1c of: sex, age, diabetes duration, therapy type and modification before the pandemic, abandonment of the treatment, previous problems with glycemic control, or change in body weight and physical activity during the lockdown, was found. The previous macrovascular complications were the only variable that affected the increase in HbA1c (p = 0.0072), OR = 5.33. CONCLUSIONS: The COVID-19 pandemic has not revealed worsened glycemic control in patients with type 2 diabetes, in general. The patients with macrovascular complications turned out to be at risk of the harmful impact of the restrictions on the HbA1c.

Low metformin dose and its therapeutic serum concentration in prediabetes.

This prospective study aimed to analyze whether the patients with pre-diabetes (pre-DM) reach the TC (therapeutic concentration) of the metformin during repeated, low, constant drug dose. The guidelines do not recommend any metformin dose for this group of patients. Based on the previous study after a dose of 1700 mg/day the patients seem to reach the therapeutic drug concentration, which guarantees the glycemic effect. Twenty patients with new-diagnosed pre-DM were treated with a 1500 mg/day regimen of the metformin for 15 weeks. The serum concentration of the drug was assessed by liquid chromatography-mass spectrometry technique at 6 and 15 week of the treatment. The correlation of the serum metformin concentration with BMI (body mass index) and patients' weight was also performed. The mean metformin concentration was: 4.65 µmol/L (± 2.41) and 5.41 µmol/L (± 3.44) (p = 0.27) after 6 and 15 weeks of the treatment respectively. There was a positive correlation between the serum concentration of the metformin and body weight (but not BMI) in the 15th week of the therapy (p = 0.04)- the higher body weight the higher concentration of the metformin. Patients with pre-diabetes can be successfully treated with a low dose of metformin, to reach the drug's therapeutic concentration. Body weight can impact the metformin serum concentration during long-term treatment what should be taken into consideration when choosing the dose because of its pleiotropic effect e.g. on the cardiovascular system via reduction of the oxidative stress and would be not connected with the drug's hypoglycemic effect.ClinicalTrials.gov number: NCT03398356; date of first registration: 01/07/2018.

Metformin has no impact on nitric oxide production in patients with pre-diabetes.

AIMS/INTRODUCTION: The authors evaluated the impact of different dose of metformin on NO (nitric oxide) production in subjects with pre-diabetes. MATERIALS AND METHODS: The metformin-naïve patients from one Diabetic Center with newly diagnosed pre-diabetes, without cardio-vascular diseases, were randomized (based on the identification number, individual for each inhabitant in the country) for treatment with different doses of metformin (group A 3 × 500 mg, group B 3 × 1000 mg) for 12 weeks. Then, the subjects from group B were switched to dose 3 × 500 for the last 3 weeks. The wide panel of L-arginine/NO pathway metabolites concentrations was assessed using the liquid chromatography-mass spectrometry technique. RESULTS: Between October 2017 and December 2018, 36 individuals were initially randomized to intervention groups. The study was completed with 25 subjects: 14 patients in group A, 11 in group B; also 11 healthy volunteers were recruited. There was no difference between participants with pre-diabetes and healthy volunteers as regards the baseline characteristics except for fasting glucose and fatty liver. The decrease of L-citrulline concentration only was reported for treatment groups during the intervention period, with no change for the other NO-production related substances. CONCLUSION: It was the first study on the in vivo release of NO in humans with different metformin doses in patients with pre-diabetes. Metformin did not seem to increase NO production measured by the citrulline plasma levels, irrespective of the dose. The citrulline concentration change might indicate the drug impact on the condition of the enterocytes.

The impact of Sample Handling Time on metformin serum concentration.

This is an informative article which can help research providers to arrange and conduct studies dedicated to the assessment of metformin serum concentrations. If there is a problem with coordination of sample preparation and it is necessary to measure metformin concentration, two hours gap between blood drain and centrifugation has no impact on the results.

Spontaneous visceral artery dissections in otherwise normal arteries: Clinical features, management, and outcomes compared with fibromuscular dysplasia.

OBJECTIVE: Visceral artery dissection with otherwise normal-appearing arteries (VADNA), diagnosed on imaging and suggestive of segmental arterial mediolysis, is a poorly understood disease entity. Study objectives were to define the clinical features, management, and outcomes of patients with VADNA compared with patients with fibromuscular dysplasia (FMD). METHODS: In this single-center retrospective cohort study, consecutive patients with a diagnosis of VADNA or FMD evaluated in the Mayo Clinic Gonda Vascular Center (January 1, 2000-April 1, 2017) were identified. Patient demographics, symptom presentation, management, composite adverse arterial events (recurrent arterial dissection, stroke or transient ischemic attack, myocardial infarction, mesenteric or renal infarction, or need for revascularization), and overall survival were compared between VADNA and FMD patients. RESULTS: There were 103 VADNA patients (age [mean ± standard deviation], 51.7 ± 11.0 years; 27.9% female) and 248 FMD controls (49.8 ± 8.9 years; 81.8% female) identified. The most common symptom for VADNA patients was abdominal or flank pain (80.6%). For FMD, chest pain, headache, and dizziness were more frequent presenting complaints. The median follow-up was longer for VADNA patients (42 months; interquartile range, 9-76 months) compared with FMD patients (19 months; interquartile range, 0.6-52 months; P < .001). During this time interval, there were twofold more composite arterial events in the VADNA group compared with the FMD group (17% vs 8.1%; P = .01). This difference was primarily driven by recurrent dissections. All-cause mortality was low and similar for both groups (3.8% vs 0.4%; P = .10). CONCLUSIONS: VADNA patients carry a higher risk of recurrent arterial events compared with those with FMD. This difference was primarily driven by recurrent dissections.

Effectiveness and safety of apixaban and rivaroxaban for acute venous thromboembolism therapy in patients with extremes in bodyweight.

OBJECTIVES: To investigate the association of extremes in bodyweight (EBW) and outcomes in patients with acute venous thromboembolism (VTE). Recurrent VTE, major bleeding, and clinically relevant non-major bleeding were compared between patients with bodyweight <60 kg, 60-120 kg, and >120 kg. METHODS: Consecutive patients enrolled in the Mayo Clinic VTE Registry (03/28/2013-8/31/2019) with acute VTE were followed prospectively. Patient status was assessed in person, by mailing a written questionnaire, or by a scripted phone interview. RESULTS: Among 2577 patients with weight ranging from 27.0 kg to 263.2 kg, 2123 (82%) had a bodyweight between 60 and 120 kg, 223 (8.7%) had bodyweight < 60 kg, and 230 (8.9%) had bodyweight >120 kg. Patients with bodyweight <60 kg treated with DOACs had higher 3- and 6-month incidence of major bleeding compared to the bodyweight 60-120kg group (4.4% vs 1.1%, P = .03, and 4.4% vs 1.4%, P = .05, respectively). Patients with bodyweight >120 kg and cancer on rivaroxaban had higher VTE recurrence compared to bodyweight 60-120kg group (P = .01). CONCLUSIONS: Treatment of acute VTE is associated with a higher incidence of bleeding in patients with bodyweight <60 kg. A higher VTE recurrence rate occurred only in cancer patients with bodyweight >120 kg on rivaroxaban.