Preconceptional thyrotropin level in euthyroid women is inversely associated with the live birth rate in first in vitro fertilization cycle.

INTRODUCTION: Thyroid disorders have been associated with adverse reproductive outcome. Whether the preconceptional level of thyrotropin (TSH) in euthyroid women impacts on in vitro fertilization (IVF) outcome has been debated. This study reports the outcome of first IVF cycle in euthyroid women in relation to TSH level. MATERIAL AND METHODS: A retrospective study was conducted in women referred for fertility treatment in the period 1 January 2012 until 31 March 2014. Among the exclusion criteria were thyroid medication at referral and comorbidities. TSH was measured as part of the fertility workup, and women were followed until pregnancy loss or live birth. Outcome as well as patient characteristics were prospectively collected from a treatment database. RESULTS: A total of 623 euthyroid women underwent their first IVF cycle. The live birth rate was 27.0% (n = 168). Comparing women with a preconceptional TSH level above vs below 2.5 mIU/L, we found lower odds for clinical pregnancy (adjusted odds ratio [aOR] 0.52; 95% CI 0.29-0.95), and lower odds for live birth (aOR 0.53; 95% CI 0.29-0.99). CONCLUSIONS: A preconceptional TSH level >2.5 mIU/L was associated with lower odds for clinical pregnancy and live birth in euthyroid healthy women undergoing first IVF cycle.

Bone turnover decreases and bone structure improves during treatment with weekly high-dose methylprednisolone for 12 weeks in Graves' orbitopathy.

PURPOSE: Weekly treatment with the intravenous glucocorticoid methylprednisolone for 12 weeks is mainstay in the treatment of Graves' orbitopathy but may decrease bone mass and impair bone structure. We therefore investigated bone turnover, -mass and -structure during the treatment cause in these patients. METHODS: We included 32 patients with Graves' orbitopathy scheduled for treatment with methylprednisolone. Bone turnover and thyroid function was measured at baseline and after 3, 9, 12, and 24 weeks, bone mineral density (BMD) was measured using dual x-ray absorptiometry at baseline and after 12 and 24 weeks, and bone structure was measured using high-resolution peripheral quantitative computed tomography at baseline and after 12 weeks. RESULTS: Bone turnover and tri-iodothyronine decreased throughout the study. Cortical volumetric BMD at both the radius and tibia increased significantly by 0.98 ± 0.38% (p = 0.01) and 1.35 ± 0.50% (p = 0.01), respectively and cortical porosity at both the radius and tibia decreased significantly by -7.67 ± 3.13% (p = 0.04) and -3.30 ± 2.17% (p = 0.04), respectively. Bone mineral density was stable during the first 12 weeks but increased significantly by 2.26 ± 3.61% at the femoral neck (p < 0.01) and by 2.24 ± 4.24% at the total hip towards week 24 (p = 0.02). Stratified analyses suggested that remission of hyperthyroidism was the most important determinant of changes in bone turnover, bone mass and structure. CONCLUSION: During a 12-week course of high-dose intravenous methylprednisolone bone turnover and cortical porosity decreased and during 24 weeks follow up bone mineral density increased. In terms of bone, methylprednisolone therefore is a safe treatment for Graves' orbitopathy.

Effect of Vitamin D Supplementation on Graves' Disease: The DAGMAR Trial.

Objective: Treatment options in Graves' disease (GD) are limited and do not target the underlying autoimmunity, and relapse rates following a course of antithyroid drug (ATD) reach 50%. Previous research has shown promising results for a role of vitamin D in GD. We aimed to investigate whether vitamin D reduces failure to enter and sustain remission in patients with GD treated with ATD. Design: A multicenter, double-blinded, randomized placebo-controlled trial comparing vitamin D 70 mcg once daily (2800 IU) or placebo. The intervention was given first as add-on to ATD treatment, maximally 24 months, and then for 12 months after ATD cessation. Inclusion period was from 2015 to 2017 and study completion by December 2020. Patients included were adults with a first-time diagnosis of GD treated with ATD. Exclusion criteria included pregnancy and glucocorticoid treatment. The primary endpoint was failure to enter and sustain remission defined as relapse of hyperthyroidism within 12 months after ATD cessation, inability to stop ATD within 24 months, or radioiodine treatment or thyroidectomy. Two hundred seventy-eight patients were included in the study, and 4 patients withdrew consent. No adverse effects were found. Results: Participants were aged 44 ± 14 years at enrollment and 79% were female. The risk of failure to enter and sustain remission was 42% [95% confidence interval (CI) 33-50%] in the vitamin D group and 32% [CI 24-40%] in the placebo group corresponding to a relative risk of 1.30 [CI 0.95-1.78]. Conclusions: Vitamin D supplementation did not improve the treatment of GD in patients with normal or insufficient vitamin D status. Thus, supplementation with high-dose vitamin D cannot be recommended for GD. Study registration: ClinicalTrials.gov NCT02384668.

Hyperthyroidism in pregnancy: design and methodology of a Danish multicenter study.

BACKGROUND: Graves' disease (GD) is the main cause of hyperthyroidism in women of the fertile age. In pregnant women, the disease should be carefully managed and controlled to prevent maternal and fetal complications. Observational studies provide evidence of the adverse effects of untreated hyperthyroidism in pregnancy and have in more recent years substantiated a risk of teratogenic side effects with the use of antithyroid drugs (ATDs). These findings have challenged the clinical recommendations regarding the choice of treatment when patients become pregnant. To extend observational findings and support future clinical practice, a systematic collection of detailed clinical data in and around pregnancy is needed. METHODS: With the aim of collecting clinical and biochemical data, a Danish multicenter study entitled 'Pregnancy Investigations on Thyroid Disease' (PRETHYR) was initiated in 2021. We here describe the design and methodology of the first study part of PRETHYR. This part focuses on maternal hyperthyroidism and recruits female patients in Denmark with a past or present diagnosis of GD, who become pregnant, as well as women who are treated with ATDs in the pregnancy, irrespective of the underlying etiology. The women are included during clinical management from endocrine hospital departments in Denmark, and study participation includes patient questionnaires in pregnancy and postpartum as well as review of medical records from the mother and the child. RESULTS: Data collection was initiated on November 1, 2021 and covered all five Danish Regions from March 1, 2022. Consecutive study inclusion will continue, and we here report the first status of inclusion. As of November 1, 2022, a total of 62 women have been included in median pregnancy week 19 (interquartile range (IQR): 10-27) with a median maternal age of 31.4 years (IQR: 28.5-35.1). At inclusion, 26 women (41.9%) reported current use of thyroid medication; ATDs (n = 14), Levothyroxine (n = 12). CONCLUSION: This report describes a newly established systematic and nationwide collection of detailed clinical data on pregnant women with hyperthyroidism and their offspring. Considering the course and relatively low prevalence of GD in pregnant women, such nationwide design is essential to establish a sufficiently large cohort.

Revised Danish guidelines for the cancer surveillance of patients with Cowden Syndrome.

INTRODUCTION: Cowden syndrome is a cancer predisposition syndrome caused by pathogenic variants in PTEN. The affected patients possess an increased risk of breast, thyroid, renal, colorectal, endometrial cancers as well as malignant melanoma. Thus prophylactic surveillance and follow up is crucial for these patients. METHODS: A review of the literature including existing guidelines from the years 1996 until 2017 was carried out. In total, 2078 scientific papers were identified through database searches on Cowden syndrome. Among these, 11 manuscripts were included based on scientific relevance and quality. Expert consensus was reached to define management guidelines. RESULTS: The literature revealed a high risk of cancer in specific organs for patients diagnosed with Cowden Syndrome. Alternative management guidelines were proposed and discussed. CONCLUSIONS: Here we propose a revised set of management guidelines for patients with Cowden syndrome in Denmark to address the increased risk of various cancer types.

Arterial Stiffness and Blood Pressure in Patients Newly Diagnosed with Graves' Disease Compared with Euthyroid Controls.

INTRODUCTION AND OBJECTIVE: The excess cardiovascular morbidity and mortality in hyperthyroidism and Graves' disease (GD) is inadequately understood. We aimed to elucidate whether well-established cardiovascular risk factors such as arterial stiffness in terms of pulse wave velocity (PWV) and blood pressure differ in GD and controls. METHODS: This was a cross-sectional study comparing 55 hyperthyroid patients with newly diagnosed GD and 55 euthyroid, population-based controls matched for age, sex and menopausal status. PWV and blood pressure were measured in office (SphygmoCor Xcel) and 24-h ambulatory settings (Arteriograph). Differences between groups were assessed using adjusted linear regression analysis. RESULTS: Compared to controls, GD patients showed higher PWV in the 24-h but not in the office setting with an adjusted 24-h PWV difference of 1.0 (95% CI: 0.6-1.5) m/s. PWV was higher in GD at both day and night, and nightly PWV dipping was lower (-5.5, 95% CI: -10.4 to -0.6%). Furthermore, central and brachial pulse pressure was significantly higher in both the office and 24-h setting, whereas nightly central pulse pressure dipping was significantly lower in GD (-5.4, 95% CI: -10.5 to -0.2%). Mean arterial pressure did not differ between the groups. CONCLUSIONS: Despite comparable blood pressure, GD is associated with a higher 24-h PWV that was not detected in the office setting. Pulse pressure was higher in GD, whereas mean arterial pressure did not differ between the groups. Longitudinal studies should pursue whether higher PWV might be a piece to the puzzle of understanding the increased risk of cardiovascular disease in hyperthyroidism and GD.

Effects of Supplemental Vitamin D on Muscle Performance and Quality of Life in Graves' Disease: A Randomized Clinical Trial.

Background: Vitamin D deficiency has been proposed to have a role in the development and course of Graves' disease (GD). Muscle weakness and quality of life (QoL) impairments are shared features of GD and vitamin D deficiency. We aimed at investigating whether vitamin D supplementation would improve restoration of muscle performance and thyroid-related QoL in GD and at describing the effect of anti-thyroid medication (ATD) on these outcomes. Methods: In a double-blinded clinical trial, hyperthyroid patients with a first-time diagnosis of GD were randomized to vitamin D 70 µg (2800 IU)/day or matching placebo as add-on to standard ATD. At baseline and after 3 and 9 months of intervention, we assessed isometric muscle strength, muscle function tests, postural stability, body composition, and QoL-impairment by using the ThyPRO questionnaire. Linear mixed modeling was used to analyze between-group differences. (The DAGMAR study clinicaltrials.gov ID NCT02384668). Results: Nine months of vitamin D supplementation caused an attenuation of muscle strength increment in all muscle measures investigated, significant at knee extension 60° where the increase was 24% lower (p = 0.04) in the vitamin D group compared with placebo. Compared with placebo, vitamin D supplementation tended to reduce gain of lean body mass (-24%, p = 0.08). Vitamin D supplementation significantly impeded alleviation of Composite QoL and the same trend was observed for the Overall QoL-Impact and Impaired Daily Life scales. In response to ATD, all measures improved significantly. The increase in muscle strength ranged from 25% to 40% (pall < 0.001), and increment of lean body mass was 10% (p < 0.001). Large changes were observed in all QoL scales. Conclusions: Nine months of vitamin D supplementation caused unfavorable effects on restoration of muscle performance. In contrast, ATD treatment was associated with marked improvement in all measures of muscle performance and thyroid-related QoL. In patients with newly diagnosed GD, high-dose vitamin D supplementation should not be recommended to improve muscle function, but ATD is of major importance to alleviate muscle impairment.

Effect of 9 months of vitamin D supplementation on arterial stiffness and blood pressure in Graves' disease: a randomized clinical trial.

PURPOSE: Risk of cardiovascular disease (CVD) is increased in Graves' disease (GD). CVD is predicted by increased pulse wave velocity (PWV) and blood pressure (BP). GD and these risk factors are all associated with lower levels of vitamin D. We aimed to assess the effect of supplemental vitamin D on PWV and BP in GD. METHODS: In a double-blinded trial, newly diagnosed GD patients were randomized to vitamin D3 70 µg/day (n = 44) or placebo (n = 42) as add-on to anti-thyroid medication. At baseline, 3 and 9 months PWV, BP and wave analysis were performed in office and 24 h setting. Between-group differences in change at 9 months were analyzed using linear mixed modelling. In subanalysis, effect of intervention in regard to baseline vitamin D insufficiency (25(OH)D < 50 nmol/L) was investigated. (The DAGMAR study, clinicaltrials.gov ID NCT02384668). RESULTS: PWV was unaffected by intervention in main analysis. However in the subanalysis, comparing the response to intervention in the vitamin D insufficient (n = 28) and the vitamin D replete patients, supplemental vitamin D induced a significant decrease in office PWV of 1.2 (95% CI: -2.3; -0.1) m/s compared to placebo. Of notice, baseline PWV was non-significantly higher among the vitamin D insufficient as compared to the replete participants. In response to vitamin D, office central systolic BP (-3.9 (95% CI: -7.5; -0.3) and brachial mean BP (-3.3 (95% CI: -6.5; -0.3) declined whereas 24 h measurements were unaffected. CONCLUSIONS: High-dose vitamin D supplementation did not affect PWV. We observed significant reduction in office but not 24 h BP. Subanalysis showed a clinically relevant PWV reduction among vitamin D insufficient participants, although regression towards the mean might contribute to findings. Further studies on supplemental vitamin D in GD should focus on patients with vitamin D insufficiency.

Muscle Performance and Postural Stability Are Reduced in Patients with Newly Diagnosed Graves' Disease.

Background: Reduced muscle strength is an acknowledged symptom of Graves' disease, but the knowledge on severity is sparse. This study aimed to investigate muscle strength, balance, and muscle function in patients with Graves' disease compared to age- and sex-matched healthy controls. Methods: Using a cross-sectional design, 55 patients newly diagnosed with Graves' disease were compared to 55 euthyroid controls, matched on sex, age, and menopausal status. Isometric muscle strength (N) and maximum force production (N/s) were measured across different muscles groups using a dynamometer chair and postural stability (balance) in different positions using a stadiometer. Muscle function was assessed using the Timed-Up-and-Go test and the Repeated Chair Stand test. Results: Patients and controls were well matched. Handgrip maximum muscle strength as well as strength at elbow and knee flexion and extension were significantly impaired in patients compared to controls. Maximum force production was only significantly reduced at elbow flexion. Patients performed the Timed-Up-and-Go and the Repeated Chair Stand test significantly slower than controls, and postural stability was significantly reduced in patients compared to controls in all positions. Free triiodothyronine correlated with reduced muscle strength and postural stability. Conclusions: At the time of diagnosis, Graves' disease is associated with impaired maximum muscle strength, performance, and balance, whereas maximum force production is overall comparable to euthyroid controls.

Nocturnal hypertension and impaired sympathovagal tone in Turner syndrome.

OBJECTIVE: Increased blood pressure (BP), night: day BP ratio, and heart rate is seen in Turner syndrome (TS), and an increased risk of ischaemic heart disease and type 2 diabetes, as well as aortic dilatation and dissection. We hypothesized that altered heart rate variability is present in TS in comparison with controls, and can be influenced by hormonal replacement therapy (HRT). MATERIAL AND METHODS: We examined the impact of HRT on sympathovagal control of heart rate variability. Patients (n = 8, aged 29.5 +/- 5.3 years; no treatment or HRT) and controls (n = 8, aged 28.5 +/- 4.2 years; no treatment) were examined by short-term spectral analysis (supine-standing), bedside neuropathy tests, and 24-h ambulatory BP. N-terminal pro-brain natriuretic peptide (BNP), renin, aldosterone and urinary albumin excretion was determined. The interaction between position and status (TS or control) was examined for data from spectral analysis. RESULTS: Low-frequency (LF) power, coefficient of component variation of LF (both measures of sympathetic and vagal activity), and the LF: high-frequency (HF) power ratio (a measure of sympathovagal balance) were diminished in TS compared with controls, especially during standing. Systolic and diastolic night ambulatory BP (both P = 0.03), and systolic and diastolic night: day ratio (P = 0.01; P = 0.004) was increased in TS. During HRT diastolic day (P = 0.05) and 24-h diastolic ambulatory BP (P = 0.08) decreased. N-terminal pro-BNP was elevated in TS. CONCLUSION: Decreased sympathovagal balance or tone and nocturnal hypertension is present in TS, and N-terminal pro-BNP is elevated. HRT did not modulate the sympathovagal tone, but decreased BP. These changes may be linked to the increased cardiovascular risk and possibly the increased risk of aortic dilatation in TS.

High Level of Agreement between Electronic and Paper Mode of Administration of a Thyroid-Specific Patient-Reported Outcome, ThyPRO.

INTRODUCTION AND PURPOSE: Use of electronic questionnaires to collect health-related quality-of-life data has evolved as an alternative to paper questionnaires. For the electronic questionnaire to be used interchangeably with the validated paper questionnaire, measurement properties similar to the original must be demonstrated. The aim of the present study was to assess the equivalence between the paper version and the electronic version of the thyroid-related quality-of-life questionnaire ThyPRO. METHODS: Patients with Graves' hyperthyroidism or autoimmune hypothyroidism in a clinically stable phase were included. The patients were recruited from two endocrine outpatient centers. All patients completed both versions in a randomized test-retest set-up. Scores were compared using intraclass correlation coefficients (ICCs), paired t tests and Bland-Altman plots. Limits of agreement were compared with data from a previous paper-paper test-retest study. RESULTS: 104 patients were included. ICCs were generally high for the 13 scales, ranging from 0.76 to 0.95. There was a small but significant difference in the scale score between paper and electronic administration for the Cosmetic complaints scale, but no differences were found for any other scale. Bland-Altman plots showed similar limits of agreement compared to the earlier test-retest study of the paper version of ThyPRO. CONCLUSION: Based on our analyses using ICCs, paired t tests and Bland-Altman plots, we found adequate agreement between the paper and electronic questionnaires. The statistically significant difference in score found in the Cosmetic complaints scale is small and probably clinically insignificant.

[Treatment with amiodarone]. / Behandling med amiodaron.

Amiodarone is an effective antiarrhythmic drug for supra­ven­tri­cular and ventricular arrhythmias. A majority of patients treated with amiodarone suffer from mild adverse events, however, serious life-threatening adverse events caused by amiodarone are also seen. This review describes the pharmacology, interac­tions, side and adverse effects of amiodarone and highlights the importance of a systematic interdisciplinary follow-up protocol for outpatients treated with amiodarone.

Pulse pressure and diurnal blood pressure variation: association with micro- and macrovascular complications in type 2 diabetes.

BACKGROUND: In nondiabetic subjects pulse pressure (PP) is an independent predictor of cardiovascular disease and microalbuminuria. Reduced circadian blood pressure (BP) variation is a potential risk factor for the development of diabetic complications. We investigated the association between retinopathy, nephropathy, macrovascular disease, PP, and diurnal BP variation in a group of type 2 diabetic patients. METHODS: In 80 type 2 diabetic patients we performed 24-h ambulatory BP (AMBP) and fundus photographs. Urinary albumin excretion was evaluated by urinary albumin/creatinine ratio. Presence or absence of macrovascular disease was assessed by an independent physician. RESULTS: Forty-nine patients had no detectable retinal changes (grade 1), 13 had grade 2 retinopathy, and 18 had more advanced retinopathy (grades 3-6). Compared to patients without retinopathy (grade 1), patients with grades 2 and 3-6 had higher PP and blunted diurnal BP variation: night PP 55 +/- 10 mm Hg, 64 +/- 10 mm Hg, 61 +/- 15 mm Hg, P < .05 and systolic night/day ratio 89.3% +/- 7%, 94.6% +/- 8%, and 92.0% +/- 6%, P < .05 (grade 1, 2, and 3-6, respectively). Comparing nephropathy groups (45 normo-, 19 micro-, and 15 macroalbuminuric patients) results were similar: night PP 54 +/- 9 mm Hg, 57 +/- 10 mm Hg, and 70 +/- 15 mm Hg, P < .001 and systolic night/day ratio 88.9% +/- 7%, 92.0% +/- 7%, and 94.9% +/- 7%, P < .02. Likewise, compared to patients without macrovascular disease (n = 55), patients with this complication (n = 25) had higher AMBP values: night PP 57 +/- 12 mm Hg v 63 +/- 11 mm Hg, P < .05 and systolic night/day ratio 89.2% +/- 6% v 94.1% +/- 9%, P < .01. CONCLUSIONS: Increased PP and blunted diurnal BP variation are hemodynamic abnormalities associated with micro- and macrovascular complications in type 2 diabetes.

[Rare, severe hypersensitivity reaction to potassium iodide]. / Svær hypersensitivitetsreaktion ved behandling af tyrotoksikose med kaliumiodid

The literature reports a large variety of adverse reactions to potassium iodide. A severe hypersensitivity reaction to potassium iodide in a 51-year-old woman with Graves' thyrotoxicosis is described. Following administration the patient developed sialadenitis, conjunctivitis, stomatitis and acneiform iododerma that responded dramatically to withdrawal of the potassium iodide and administration with corticosteroids. Awareness of these adverse reactions may prevent prolonged hospitalization and unnecessary tests and treatments.

[Treatment with amiodarone].

Amiodarone is an effective antiarrhythmic drug for supra-ven-tri-cular and ventricular arrhythmias. A majority of patients treated with amiodarone suffer from mild adverse events, however, serious life-threatening adverse events caused by amiodarone are also seen. This review describes the pharmacology, interac-tions, side and adverse effects of amiodarone and highlights the importance of a systematic interdisciplinary follow-up protocol for outpatients treated with amiodarone.

Targeting nocturnal hypertension in type 2 diabetes mellitus.

Several studies in different populations have suggested that nighttime blood pressure (BP) is a stronger predictor of cardiovascular events than daytime BP. Consequently, treatment strategies to target nighttime BP have come into focus. The aim of the present study was to investigate the effect of change of administration time of antihypertensive drugs. We included 41 patients with type 2 diabetes mellitus and nocturnal hypertension (nighttime systolic BP >120 mm Hg) in an open-label, crossover study. Patients were randomized to 8 weeks of either morning or bedtime administration of all of the individual's once-daily antihypertensive drugs, followed by 8 weeks of switched dosing regimen. Bedtime administration of antihypertensive drugs resulted in a significant reduction in nighttime (7.5 mm Hg; P<0.001) and 24-hour (3.1 mm Hg; P=0.014) systolic BP, with a nonsignificant reduction in daytime (1.3 mm Hg; P=0.336) systolic BP. We did not find morning BP surge to be different between dosing regimens. Levels of C-reactive protein were significantly lower with bedtime administration, which may indicate an effect on low-grade inflammation. We found no difference in urinary albumin excretion, regardless of albuminuria status. Urinary sodium/creatinine was significantly increased and urinary osmolality significantly reduced with bedtime administration, which can be interpreted as increased nocturnal natriuresis. In patients with type 2 diabetes mellitus and nocturnal hypertension, administration of once-daily antihypertensive drugs at bedtime may be favorable. The increased nocturnal natriuresis may reflect increased effect of bedtime-administered thiazides and renin-angiotensin system inhibitors, suggesting a potential mechanism of the observed effects on BP with chronotherapeutic intervention.

Invasive validation of arteriograph estimates of central blood pressure in patients with type 2 diabetes.

BACKGROUND: Central blood pressure (BP) has attracted increasing interest because of a potential superiority over brachial BP in predicting cardiovascular morbidity and mortality. Several devices estimating central BP noninvasively are now available. The aim of our study was to determine the validity of the Arteriograph, a brachial cuff-based, oscillometric device, in patients with type 2 diabetes. METHODS: We measured central BP invasively and compared it with the Arteriograph-estimated values in 22 type 2 diabetic patients referred to elective coronary angiography. RESULTS: The difference (invasively measured BP minus Arteriograph-estimated BP) in central systolic BP (SBP) was 4.4±8.7 mm Hg (P = 0.03). The limits of agreement were ±17.1 mm Hg. CONCLUSIONS: Compared with invasively measured central SBP, we found a systematic underestimation by the Arteriograph. However, the limits of agreement were similar to the previous Arteriograph validation study and to the invasive validation studies of other brachial cuff-based, oscillometric devices. A limitation in our study was the large number of patients (n = 14 of 36) in which the Arteriograph was unable to analyze the pressure curves. In a research setting, the Arteriograph seems applicable in patients with type 2 diabetes. CLINICAL TRAIL REGISTRATION: ClinicalTrials.gov ID NCT01538290.

Assessment of central blood pressure in patients with type 2 diabetes: a comparison between SphygmoCor and invasively measured values.

BACKGROUND: The SphygmoCor is used for noninvasive assessment of ascending aortic blood pressure (BP). However, the validity of the SphygmoCor transfer function has not been tested in an exclusively type 2 diabetic patient sample. Calibration with systolic (SBP) and diastolic (DBP) brachial BP has previously been associated with substantial imprecision of central BP estimates. We hypothesized that different noninvasive calibration strategies might improve the accuracy of the estimated ascending aortic BPs. METHODS: In 34 patients with type 2 diabetes we estimated ascending aortic SBP and DBP using the SphygmoCor device and compared these data with invasively recorded data. The validity of the transfer function was assessed by calibrating with invasively recorded DBP and mean BP (MBP). The influence of noninvasive calibration strategies was assessed by calibrating with brachial oscillometric SBP+DBP vs. DBP+MBP using a form factor (ff) of 0.33 and 0.40, respectively. RESULTS: When calibrating with invasive BP, the difference between estimated and invasively measured ascending aortic SBP and DBP was -2.3±5.6/1.0±0.9 mm Hg. When calibrating with oscillometric brachial BPs, the differences were -9.6±8.1/14.1±6.2 mm Hg (calibration with SBP and DBP), -8.3±11.7/13.9±6.1 mm Hg (DBP and MBP; ff = 0.33), and 1.9±12.2/14.1±6.2 mm Hg (DBP and MBP; ff = 0.40), respectively. Calibration with the average of 3 brachial BPs did not improve accuracy. CONCLUSIONS: The SphygmoCor transfer function seems valid in patients with type 2 diabetes. Noninvasive calibration with DBP and MBP (ff = 0.40) enables accurate estimation of mean ascending aortic SBP at the group level. However, the wide limits of agreement indicate limited accuracy in the individual patient. CLINICAL TRIALS REGISTRATION: Clinical Trials No. NCT01538290.

Reproducibility of the ambulatory arterial stiffness index in patients with type 1 diabetes mellitus.

OBJECTIVES: The ambulatory arterial stiffness index (AASI) has been proposed as a novel indirect measure of arterial stiffness. We compared the repeatability of AASI and pulse pressure (PP), another marker of arterial stiffness, both computed from repeat 24-h ambulatory blood pressure recordings in patients with type 1 diabetes mellitus. METHODS: Twenty-eight patients with type 1 diabetes mellitus and no previous or present treatment with antihypertensive drugs were recruited from outpatient clinics in Aarhus County and underwent two 24-h ambulatory blood pressure measurements, performed within 2 weeks in all participants except one. The repeatability of AASI and PP was assessed by (i) the Intraclass Correlation Coefficient (ICC) and (ii) the percentage of maximal variation, i.e. two times SD of the difference in the percentage of four times the SD of the mean of the paired measurements. RESULTS: The repeatability of AASI was considerably lower than for PP as estimated by ICC (0.38 vs. 0.90). The difference between ICCPP and ICCAASI was 0.51 confidence interval (0.25-0.82). Similarly, percentage of maximal variation was 68 and 23% respectively. CONCLUSION: AASI has a low repeatability compared with PP in type 1 diabetic patients. This questions the potential implementation of AASI in the daily clinic as a measure of arterial stiffness. Further studies are necessary to clarify this.