| 1. |
- Ludvigsson, Jonas F., et al.
(författare)
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Milk consumption during pregnancy and infant birth weight
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Annan publikation (övrigt vetenskapligt/konstnärligt)abstract
- Objective To examine birth weight and risk of low birth weight (≤2 499g, LBW) in relation to milk intake.Design Questionnaire-based study.Setting Southeast SwedenPopulation Single birth infants within the ABIS project included during a two-year period (ABIS = All Babies In Southeast Sweden).Main outcome measures Birth weight and LBW.Results Low milk intake during pregnancy was associated with a decrease in infant birth weight (P<0,01l, Kruskal-Wallis) but did not correlate with LBW (P=0.434, Chi-2) (10 489 infants with complete data)When adjusting for confounders (regression analyses) low milk intake during pregnancy was associated with a decrease in infant birth weight (adjusted P for trend<0,001) and with an increased risk of LBW (adjusted P for trend= 0.028) (9 097 infants with complete data).Conclusion This study suggests that low milk intake in the pregnant mother is associated with lower birth weight of the newborn. Further research is needed to evaluate the relationship between low milk intake and the risk of LBW.
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| 2. |
- Ludvigsson, Jonas F., et al.
(författare)
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Tissue Transglutaminase autoantibodies in cord-blood from children of healthy mothers
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Annan publikation (övrigt vetenskapligt/konstnärligt)abstract
- Background/aims: Detemlination of tissue. transglutaminase autoantibodies (tTGAA) is a sensitive and specific diagnostic tool for large-scale screening for coeliac disease. Early diagnosis and treatment of coeliac disease eliminate gastrointestinal symptoms ru1d reduce the risk of secondmy complications. The purpose of this study was to correlate maternal and infant background factors and their association with tTGAA levels in cord-blood of the ABIS child cohort (ABIS= All Babies In Southeast Sweden).Methods: 2518 cord-blood samples were screened using immunoprecipitation for autoantibodies against tissue transglutaminase, GAD 65 (Glutamic Acid Decarboxylase) and IA-2 (Tyrosin phosphatase). Data on background factors were obtained from the mothers (questionnaire). Multiple comparisons in our analyses were handled by means of a modified Bonferroni adjustment; thus, P values ≤ 0.0019 (0.05/26) were considered to indicate statistical significance.Results: 10/2518 (0.40%) were positive for tTGAA (>0.040 Arbitrary Units (AU)). No cord-blood specimen from known coeliac mothers were positive for tTGAA. Neither absolute tTGAA nor positive tTGAA levels (>0.040AU) correlated with the independent variables in our model Seasonal variation in tTGAA levels (P=0.018) did not reach significance when adjusting for multiple comparisons.Conclusions: TTGAA levels do not seem to be influenced by the environmental or physical factors in our study, but the issue of seasonal variations in tTGAA levels should be further explored.
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| 3. |
- Axelsson, Stina, et al.
(författare)
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Preserved C-peptide 30 months after GAD-alum treatment of children and adolescents with recent-onset type 1 diabetes, and its relation to immune markers
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Annan publikation (övrigt vetenskapligt/konstnärligt)abstract
- Glutamic acid decarboxylase 65 kDa isoform (GAD65) is a major autoantigen in type 1 diabetes (T1D). Although alum-formulated GAD65 (GAD-alum) induced preservation of residual insulin secretion in a previous clinical Phase II trial, recent Phase II and Phase III trials failed to reach their primary end-points. The European Phase III trial was therefore closed after 15 months, and the 30 months follow-up period was completed only for a minority of the patients. This study aimed to assess whether GAD-alum preserved β-cell function in those recent-onset T1D patients who completed their 30 months visit in the European Phase III trial, and to characterize their GAD65-induced cytokine secretion and proliferation. Peripheral blood mononuclear cells (PBMC) were isolated at baseline and after 1, 3, 9, 15 and 21 months from the 148 Swedish subjects included in the Phase III GAD-alum trial, and also at 30 months from 45 patients who had reached the final visit before the trial was closed. Patients had been randomly assigned into three arms: 4 doses of GAD-alum (4D), 2 doses of GAD-alum followed by two doses of placebo (2D), or 4 doses of placebo. Cytokine secretion was detected in cell culture supernatants by Luminex, after 7 days of in vitro culture. Cell proliferation was determined by 3H thymidine incorporation assay. Fasting and stimulated C-peptide was analysed in serum. Patients treated with 2 doses of GAD-alum had less decline of both fasting (p=0.040) and stimulated C-peptide (p=0.012) after 30 months, and a larger proportion of these patients preserved >25% of their initial stimulated C-peptide AUC compared to placebo (p=0.012). Both 2D and 4D patients showed increased PBMC proliferation to GAD65 and a cytokine profile that tended to switch towards a more predominant Th2 associated profile over time. The results support the concept of GAD-alum treatment, but no specific immune markers have been identified.
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| 4. |
- Carlsson, Jenny, 1977-, et al.
(författare)
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Determination of insulin autoantibodies using surface plasmon resonance: A screening study of newly diagnosed type 1 diabetes patients
- 2008
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Annan publikation (övrigt vetenskapligt/konstnärligt)abstract
- We have investigated the screening potential of a surface plasmon resonance (SPR)-based indirectcompetitive immunoassay for quantification of insulin autoantibodies (IAA) in sera from childrennewly diagnosed with type 1 diabetes (T1D), using a radioimmunoassay (RIA) as reference technique.The two methods agreed well with respect to sample classification of 54 sera from newly diagnosedT1D children and 32 reference sera from non-diabetic children. Interestingly, five samples from newlydiagnosed T1D patients classified as IAA-negative according to RIA were IAA-positive with the SPRbasedassay, suggesting that the SPR-based assay might provide a higher sensitivity than the referenceRIA. However, 14 percent of the analyzed samples (five samples from non-diabetics and seven fromnewly diagnosed T1D patients) gave rise to anomalously high and easily distinguishable responses withthe SPR-based method, precluding IAA-quantification. A considerable part of the paper is devoted to adiscussion of possible causes of these anomalous responses. They were not due to temporary changesin the status of the patients, such as infections at the time of sampling, and also not related tocomplement activation. It is speculated whether a plausible explanation should instead be sought in theexistence of anti-idiotypic antibodies to IAA.
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| 5. |
- Chéramy, Mikael, et al.
(författare)
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GAD65 autoantibody (GADA) responses in Type 1 diabetes patients participating in a phase III GAD-alum intervention trial
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Annan publikation (övrigt vetenskapligt/konstnärligt)abstract
- Glutamic acid decarboxylase 65 kDa isoform (GAD65) is a major autoantigen in type 1 diabetes (T1D). Although aluminum-formulated GAD65 (GAD-alum) induced preservation of residual insulin secretion in a previous clinical phase II trial, recent phase II and III trials failed to reach their primary end-points. The European phase III trial was therefore closed after 15 months, and the entire study period was completed only for a minority of the patients. This study aimed to characterize GAD65 autoantibodies (GADA) and Tyrosine phosphatase IA-2 autoantibody (IA-2A) levels, GADA IgG1-4 subclass distribution, B-cell frequencies/phenotypes and cytokine secretion. We also assessed whether GAD-alum preserved β-cell function in the small subgroup of Swedish patients who completed the 30 months visit. Serum samples and peripheral blood mononuclear cells (PBMC) were collected at baseline and after 1, 3, 9, 15 and 21 months from the 148 Swedish subjects included in the trial, and also at 30 months from the 45 patients who reached the final visit. Patients were randomly assigned to; i) 4 doses of GAD-alum (4D), ii) 2 doses of GAD-alum followed by two doses of placebo (2D), or iii) 4 doses of placebo.GADA titers were induced both in the 4D and 2D group compared to placebo, and 4D patients also displayed a higher GADA fold-change after receiving the two additional injections compared to the 2D group. The 4D group switched to a higher frequency of GADA IgG4, associated to a Th2 type response at 9 months, whereas an association between GADA fold-change and GAD65-induced in vitro cytokine secretion was observed in the 2D group. These findings suggest that the humoral response, induced by the 2D treatment, seems to be associated with a GAD65-specific cellular response, while 4D induces a distinct humoral response. Even though GADA titers were elevated, no changes in B-cell frequencies or phenotype were observed in any group. IA-2A levels declined at a similar rate in all groups during the trial.The subgroup of patients who completed the 30 month visit receiving 2 doses of GAD-alum had less decline of both fasting and stimulated C-peptide after 30 months compared to placebo. These results support the concept of GAD-alum treatment, but no specific immune markers have been identified.
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| 6. |
- Golster, Helena, et al.
(författare)
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Testing microvascular function in children and adolescents with diabetes using laser Doppler perfusion imaging : implications on flow models and measurement sites
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Annan publikation (övrigt vetenskapligt/konstnärligt)abstract
- The purpose of the present study was to examine if functional impairment of the skin microvasculature is present in young diabetic patients with and without neurophysiological signs of nerve dysfunction. Dorsal foot skin blood flow was measured in young diabetics and controls using laser Doppler perfusion irnaging (LDPI). Blood flow was- measured during supine resting flow, during change in posture and during post occlusive hyperemia. Peripheral nerve function was measured by electrophysiological studies of peroneal and sural nerve conduction. Fifty seven (57%) percent of the diabetic patients had abnormal nerve conduction in two or several nerves. Diabetics with poor metabolic control (HbAlc > 7,5 %) showed an increase in supine resting blood flow compared to better regulated diabetics and controls. No other differences in skin blood flow between diabetics and controls were seen. During change in posture, blood flow increased instead of decreased in a majority of the study subjects. Low resting blood !low levels are suggested to contribute to this absence of postural vasoconstrictor response. It is concluded that nerve conduction defects arc much more common than microvascular abnormalities measured by LDPI in the present models in young diabetic patients. Our recommendation is to increase basal resting flow before applying vasoconstricting models in yotmg subjects when using LDPI in low flow areas, as the foot skin.
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| 7. |
- Gustafsson Stolt, Ulrica, et al.
(författare)
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The problems of obtaining informed consent in screening for Type 1 diabetes involving small children
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Annan publikation (övrigt vetenskapligt/konstnärligt)abstract
- Purpose As part of a research ethical case study our objective was to explore existing and potential bioethical issues with regard to a research screening for Type 1 involving 17,000 children and their families (present outcome: 78.6%).Research design and methods The setting was ABIS (All Babies In Southeast Sweden), a presently ongoing Swedish research screening designed as a multi-centre, longitudinal and geographically located research screening for Type 1 Diabetes in an unselected birth cohort. From the perinatal questionnaire serial numbers we made a random selection of participating mothers. 293 completed the anonymous questionnaire, resulting in a response rate of 73.3%.Results The overall majority of respondents reported (1), being satisfied with the information, (2), looking upon the information as sufficient for their decision, (3), having fully understood the information and (4), having made a fully voluntary decision to participate. However, knowledge about the study varied widely and we found several variations of misunderstandings, even regarding basic facts. For example, one in three respondent was unsure (or indeed unaware) with regard to one aim being the identification of children at high risk.Condusions We have recorded flaws in research participants understanding of their own and their child's participation in a prospective screening programme, even though attention was paid to distributing information through a variety of methods. This points to the importance of giving information: in a variety of methods and also repeatedly in long-term studies.
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| 8. |
- Gustafsson Stolt, Ulrica, et al.
(författare)
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Understanding and informed consent in longitudinal studies : what action we take when we have reason to believe subjects lack sufficient understanding?
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Annan publikation (övrigt vetenskapligt/konstnärligt)abstract
- Taking the point of departure in empirical research data we discuss what action should we take when we are uncertain of to what extent participants in a prospective, longitudinal screening for pre-diabetes lack sufficient understanding?The empirical case study showed that, on one hand, an overall majority of respondents reported being satisfied with the information in several respects, but, on the other hand their knowledge and comprehension of aim, purpose and potential benefit varied widely to the extent that doubt must be put as to whether they have sufficient understanding. In this situation we need criteria or guidance as to what constitutes a sufficient understanding. A brief sutvey of ethical codes and ethical theory show, we argue, that while they enumerate some important items that the subject should be informed about, like aims, methods, anticipated benefits and potential risks, nothing substantial is said that can guide us as to what the meaning of "a sufficient understanding" is. The second question concems what is then the ethically right thing to dor We propose we have five possible alternatives: a), we can ignore the data, b), we can exclude individuals who lack sufficient understanding, c) we can give complementary information, without renewed consent, d), inform and ask for a renewed consent, and finally we can ask participants if they want to increase their understanding. We conclude that due to the ethical problems involved in screening and genetic testing of children, there is a need to develop theories or principles for guidance.
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| 9. |
- Gustavsson Stolt, Ulrica, et al.
(författare)
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Advancing the nursing perspective in screening and genetic research : ethics, informed consent and councelling
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Annan publikation (övrigt vetenskapligt/konstnärligt)abstract
- The aim of the present study was to explore ethical attitudes and reflections among nurses and midwives involved in a primaty prevention research screening for Type 1 diabetes, ABIS (All Babies In South-East Sweden). We selected a strategic sample of ten respondents (midwives, paediatric and assistant nurses) from wards involved in all information and sampling procedures. We found a general positive attitude towards this type of screening. Even though no bioethical problems were said to be experienced, there were questions raised concerning the bio-material collected. We also found variations in the respondents understanding of aims and methods, something subsequently reflected in their information to the potential ABIS participants. We argue that the findings and the potential implications can be of importance with regard to several issues of genetic testing and screening: design, information, informed consent and counselling. The study supports the opinion that nursing perspective studies are important, not only in addressing issues in regard of the new genetics, but also because of their potential value in the ethics of nursing and of research ethics.
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| 10. |
- Hanberger, Lena, et al.
(författare)
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Use of a web 2.0 portal to improve education and communication in young diabetes patients with families – A CASE STUDY
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Annan publikation (övrigt vetenskapligt/konstnärligt)abstract
- AIM: To develop a web portal designed to facilitate self-management, including diabetes-related information and social networking functions, and study its use and effects in young patients with diabetes. DESIGN AND METHOD: A Web 2.0 portal was developed in collaboration with patients, parents and their practitioners. It offered communication with local practitioners, interaction with peers and access to relevant information and services. Children and adolescents with diabetes in a geographic population of two paediatric clinics in Sweden were randomized to a group (n=233) receiving passwords for access to the portal, or a control group with no access (n=230) for one year. All subjects had access during a second study year. The portal was used on users’ own initiative only without directions from health care professionals or researchers. Measures: User activity by site visits and page visits logged per user. Health-related quality of life (HRQOL), empowerment (DES), and quality of information (QPP) questionnaires at baseline and after one and two study years. Clinical data from the Swedish paediatric diabetes quality registry SWEDIABKIDS. RESULTS: There was a continuous flow of site visits, but decreasing in summer and Christmas periods. In 119/233 families (51%) someone visited the portal the first study year and in 169/484 (35%) the second study year. More frequent page visits were seen on social networking with peers, such as blogs, stories and discussions, followed by news from the local diabetes teams. No differences were found regarding outcome variables between intervention and control group. No adverse effects related to the treatment or self-care were identified. A higher proportion of mothers compared to fathers visited once or more the first (p<0.001) and the second year (p<0.001). Those patients where someone in the family visited five times or more (active users), n=68, had shorter diabetes duration (p= 0.006), were younger (p=0.008), had lower HbA1c after one year of access (p=0.010), and were more often girls (p<0.001). Conclusions: The Web 2.0 portal appears useful as a complement to traditional care for this target group. Peer interaction seems to be a valued aspect. The use of a portal probably needs to be integrated in routine care and promoted e.g. by diabetes team members, advertisements and newsletters. Research on electronic communication targeting young people with long-term health problems need to focus more on use of Web 2.0 including gender aspects.
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