55 research outputs found

    DALI: Vitamin D and lifestyle intervention for gestational diabetes mellitus (GDM) prevention: An European multicentre, randomised trial - study protocol

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    Background: Gestational diabetes mellitus (GDM) is an increasing problem world-wide. Lifestyle interventions and/or vitamin D supplementation might help prevent GDM in some women.Methods/design: Pregnant women at risk of GDM (BMI≥29 (kg/m2)) from 9 European countries will be invited to participate and consent obtained before 19+6 weeks of gestation. After giving informed consent, women without GDM will be included (based on IADPSG criteria: fasting glucose\u3c5.1mmol; 1 hour glucose \u3c10.0 mmol; 2 hour glucose \u3c8.5 mmol) and randomized to one of the 8 intervention arms using a 2×(2×2) factorial design: (1) healthy eating (HE), 2) physical activity (PA), 3) HE+PA, 4) control, 5) HE+PA+vitamin D, 6) HE+PA+placebo, 7) vitamin D alone, 8) placebo alone), pre-stratified for each site. In total, 880 women will be included with 110 women allocated to each arm. Between entry and 35 weeks of gestation, women allocated to a lifestyle intervention will receive 5 face-to-face, and 4 telephone coaching sessions, based on the principles of motivational interviewing. The lifestyle intervention includes a discussion about the risks of GDM, a weight gain target \u3c5kg and either 7 healthy eating \u27messages\u27 and/or 5 physical activity \u27messages\u27 depending on randomization. Fidelity is monitored by the use of a personal digital assistance (PDA) system. Participants randomized to the vitamin D intervention receive either 1600 IU vitamin D or placebo for daily intake until delivery. Data is collected at baseline measurement, at 24-28 weeks, 35-37 weeks of gestation and after delivery. Primary outcome measures are gestational weight gain, fasting glucose and insulin sensitivity, with a range of obstetric secondary outcome measures including birth weight.Discussion: DALI is a unique Europe-wide randomised controlled trial, which will gain insight into preventive measures against the development of GDM in overweight and obese women. © 2013 Jelsma et al.; licensee BioMed Central Ltd

    Management goals for type 1 Gaucher disease: An expert consensus document from the European working group on Gaucher disease

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    AbstractGaucher Disease type 1 (GD1) is a lysosomal disorder that affects many systems. Therapy improves the principal manifestations of the condition and, as a consequence, many patients show a modified phenotype which reflects manifestations of their disease that are refractory to treatment. More generally, it is increasingly recognised that information as to how a patient feels and functions [obtained by patient- reported outcome measurements (PROMs)] is critical to any comprehensive evaluation of treatment. A new set of management goals for GD1 in which both trends are reflected is needed. To this end, a modified Delphi procedure among 25 experts was performed. Based on a literature review and with input from patients, 65 potential goals were formulated as statements. Consensus was considered to be reached when ≥75% of the participants agreed to include that specific statement in the management goals. There was agreement on 42 statements. In addition to the traditional goals concerning haematological, visceral and bone manifestations, improvement in quality of life, fatigue and social participation, as well as early detection of long-term complications or associated diseases were included. When applying this set of goals in medical practice, the clinical status of the individual patient should be taken into account

    The survey of recent life experiences:A psychometric evaluation

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    Hitherto, various critics have claimed that the most commonly used measure for daily hassles is confounded with psychological well-being in both content and format. In order to circumvent such contamination, the Survey of Recent Life Experiences (SRLE) was developed by Kohn and MacDonald (1992). In the present study, the SRLE was psychometrically evaluated within a general sample of the Dutch population. Confirmatory factor analysis showed that, with the exception of one item the original six-factor structure was strongly replicated. For five of six factors, internal consistency reliabilities proved satisfactory. It is argued that the rather low infernal consistency reliability of the sixth factor may be improved if additional items are subjoined. In addition yielded relationships between the SRLE and other variables were in accordance with previous research. It is therefore argued that the results are in support of cross-cultural construct validity of the SRLE. Future use within other Western European societies is recommended

    Does the tenary complex act as a secondary proton pump and a GTP synthase?

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    It has been suggested that G protein-coupled receptors can act as proton transporters, with the activated G protein-coupled receptor transporting
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