Participants and procedures
This study had a cross sectional design and was one of four baseline analyses [25,26,27] for a randomized controlled trial (ClinicalTrials.gov: NCT01714986) where “Affect School with Script Analysis” was tried against “Basic Body Awareness Therapy” for persons with diabetes, inadequate glycemic control and psychological symptoms [28, 29]. The participants were outpatients, consecutively recruited by specialist diabetes physicians or diabetes nurses, at regular follow up visits during the period 03/25/2009 to 12/28/2009. They were recruited from one secondary care specialist diabetes clinic, with a catchment population of 125,000 in southern Sweden. In this study 284 persons with T1D were included, 66% of the eligible patients (Fig. 1). Exclusion criteria were cancer, hepatic failure, end-stage renal disease, stroke with cognitive deficiency, psychotic disorder, bipolar disorder, severe personality disorder, severe substance abuse, or mental retardation. Anthropometrics, blood pressure and blood samples were collected. Data were collected from computerized medical records and the Swedish national diabetes register (S-NDR) [1, 23].
Medication
Diabetes specific treatment was divided into three groups: multiple daily insulin injections (MDII), continuous subcutaneous insulin infusion (CSII), and MDII combined with oral antidiabetic agents (OAA) (ATC code A10BA02). The indications for OAA prescription in addition to insulin were obesity and insulin resistance.
Anti-hypertensive drugs were calcium antagonists (ATC codes C08CA01–02); angiotensin-converting enzyme (ACE) inhibitors (ATC codes C09AA-BA), angiotensin II antagonists (ATC codes C09CA-DA; diuretics (ATC code C03A); selective beta-adrenoreceptor antagonists (ATC code C07AB).
Lipid-lowering drugs were HMG CoA-reductase inhibitors (statins) (C10AA).
Anthropometrics and blood pressure
Waist circumference (WC), weight, length and blood pressure were measured according to standard procedures by a nurse. Abdominal obesity was defined as WC men/women (meters): ≥ 1.02/> 0.88 [30,31,32]. General obesity was defined as Body Mass Index (BMI): ≥ 30 kg/m2 for both genders [31].
HbA1c, serum-lipids and hs-CRP
HbA1c and serum lipids analyses were performed at the department of Clinical Chemistry, Växjö Central Hospital.
Venous HbA1c was analyzed with high pressure liquid chromatography, HPLC - variant II, Turbo analyzer (Bio – Rad®, Hercules, CA, USA). HbA1c > 70 mmol/mol (> 8.6%) corresponds to the 75th percentile in the whole population sample [26].
After an overnight fast, blood samples were collected and serum-lipids were were measured directly [8], using the enzymatic colour test (Olympus AU®, Tokyo, Japan). High TC was defined as > 4.5 mmol/l, high LDL as > 2.5 mmol/l, high triglycerides as ≥1.7 mmol/l; low HDL as < 1.04 mmol/l for men, and as < 1.29 mmol/l for women [33].
Samples for hs-CRP were collected, centrifuged, and stored at − 70 C Celsius until analyzed with spectrophotometry on a Roche Cobas C501 at the diabetes laboratory, Lund University Hospital, Lund. Hs-CRP was 0.54 ± 0.02 mg/l in healthy subjects according to previous research [16]. Hs-CRP < 1, 1 to 3, and > 3 to ≤10 mg/l correspond to low-, moderate- and high-risk groups for future cardiovascular events [19]. Samples with hs-CRP ≥10 mg/l were excluded as recommended in previous research [19]. Samples stored > 1 year were excluded. Hs-CRP was available for 171 (60%) participants.
Treatment targets according to the Swedish National Guidelines for diabetes in 2009
The treatment targets recommend by the Swedish National Board of Health and Welfare were for T1D patients: 1) glycemic control: HbA1c ≤52 mmol/mol; 2) systolic/diastolic blood pressure: ≤130/≤80 mmHg; 3) serum-lipids: TC ≤4.5 and LDL ≤2.5 mmol/l [22].
Hypoglycemia episodes
A severe hypoglycemia episode was defined as needing help from another person. Episodes during the last 6 months prior to recruitment were registered.
Smoking and physical inactivity
Smokers were defined as having smoked any amount of tobacco during the last year.
Physical inactivity was defined as moderate activities, such as 30 min of walking, less than once a week.
Cardiovascular complications
Cardiovascular complications were defined as ischemic heart disease or stroke/TIA.
Statistical analysis
Analysis of data distribution using histograms revealed that age, diabetes duration, hs-CRP, triglycerides, BMI and WC were not normally distributed. Data were presented as median values (quartile (q)1, q3; range), and analyses were performed with Mann-Whitney U test. Fisher’s exact test (two-tailed) and Linear-by-Linear Association (two-tailed) were used to analyze categorical data. Crude odds ratios (CORs) were calculated, variables with P ≤ 0.10, and age independent of P-value, were entered in multiple logistic regression analyses (Backward: Wald). The Hosmer and Lemeshow test for goodness-of-fit and Nagelkerke R2 were used to evaluate each multiple logistic regression analysis model. Ordinal regression analysis (stepwise forward) was performed with 3 risk levels of hs-CRP as dependent variables. Variables with P-values ≤0.10 in simple linear regression analyses were entered into multiple linear regression analyses (Backward). Confidence intervals (CIs) of 95% were used. P < 0.05 was considered statistically significant. SPSS® version 18 (IBM, Chicago, Illinois, USA) was used for statistical analyses.