Self-tracking of physical activity in people with type 2 diabetes:a randomized controlled trial

The purpose of this study was to determine the efficacy of an online self-tracking program on physical activity, glycated hemoglobin, and other health measures in patients with type 2 diabetes. Seventy-two patients with type 2 diabetes were randomly assigned to an intervention or control group. All participants received usual care. The intervention group received an activity tracker (Fitbit Zip) connected to an online lifestyle program. Physical activity was analyzed in average steps per day from week 0 until 12. Health outcome measurements occurred in both groups at baseline and after 13 weeks. Results indicated that the intervention group significantly increased physical activity with 1.5 +/- 3 days per week of engagement in 30 minutes of moderate-vigorous physical activity versus no increase in the control group (P = .047). Intervention participants increased activity with 1255 +/- 1500 steps per day compared to their baseline (P <.010). No significant differences were found in glycated hemoglobin A1c, with the intervention group decreasing -0.28% +/- 1.03% and the control group showing -0.0% +/- 0.69% (P = .206). Responders (56%, increasing minimally 1000 steps/d) had significantly decreased glycated hemoglobin compared with nonresponders (-0.69% +/- 1.18% vs 0.22% +/- 0.47%, respectively; P = .007). To improve effectiveness of eHealth programs, additional strategies are needed

The Role of Self-Regulation in the Effect of Self-Tracking of Physical Activity and Weight on BMI

Self-tracking of health may have positive effects on lifestyle behavior and weight loss; however, not much is known about the role of psychological processes in this effect. The purpose of this study was to assess to what extent a change in self-regulation capabilities can explain weight loss after 4 and 12 months of self-tracking physical activity and weight. An explorative cohort study was conducted with measurements at baseline (T0), 4 months (T1), and 12 months (T2). Healthy adult volunteers (N = 80) were included and provided with a digital weight scale and an activity tracker. Personal characteristics as well as the intention to change weight and physical activity were measured at T0. Self-regulation capabilities (goal orientation, self-direction, decision making, and impulse control) were measured with the Self-Regulation Questionnaire at T0, T1, and T2, together with body weight. At T0, all four dimensions of self-regulation were negatively related to BMI (p <.01). At T1, weight significantly declined compared to T0 (− 2.0 kg/− 0.64 kg/m2, p <.001). At T2, this weight loss was maintained (− 1.8 kg/− 0.57 kg/m2, p <.01). At T1, intention to lose weight, self-weighing frequency, and an increase in goal orientation explained weight loss. At T2, an increase in decision making explained weight loss. Incremental self-regulation capabilities may explain weight loss after engaging in self-tracking of physical activity and weight. Future research should focus on exploring effective ways to further enhance self-regulation when using self-tracking technology and to assess the impact of different types of self-regulation stimuli on weight loss

Hepatitis in a patient with SLE: Is it autoimmune hepatitis?

In a patient with systemic lupus erythematosus (SLE), we considered the diagnosis of autoimmune hepatitis (AIH) in view of raised serum aminotransferases, hypergammaglobulinaemia, antinuclear antibodies (titre 1:10240), seronegative of markers for viral hepatitis and absence of recent hepatotoxic drug usage. The diagnosis of AIH was supported by using the scoring system, recently developed by the International Autoimmune Hepatitis Group and the excellent response to treatment with prednisone. Liver histology, however, showed no characteristic features of AIH. The relevance of liver histology and scoring for AIH in SLE with hepatic involvement is discussed

Metformin and high-sensitivity cardiac troponin I and T trajectories in type 2 diabetes patients: a post-hoc analysis of a randomized controlled trial

Background: Metformin has favorable effects on cardiovascular outcomes in both newly onset and advanced type 2 diabetes, as previously reported findings from the UK Prospective Diabetes Study and the HOME trial have demonstrated. Patients with type 2 diabetes present with chronically elevated circulating cardiac troponin levels, an established predictor of cardiovascular endpoints and prognostic marker of subclinical myocardial injury. It is unknown whether metformin affects cardiac troponin levels. The study aimed to evaluate cardiac troponin I and T trajectories in patients with diabetes treated either with metformin or placebo. Methods: This study is a post-hoc analysis of a randomized controlled trial (HOME trial) that included 390 patients with advanced type 2 diabetes randomized to 850 mg metformin or placebo up to three times daily concomitant to continued insulin treatment. Cardiac troponin I and T concentrations were measured at baseline and after 4, 17, 30, 43 and 52 months. We evaluated cardiac troponin trajectories by linear mixed-effects modeling, correcting for age, sex, smoking status and history of cardiovascular disease. Results: This study enrolled 390 subjects, of which 196 received metformin and 194 received placebo. In the treatment and placebo groups, mean age was 64 and 59 years; with 50% and 58% of subjects of the female sex, respectively. Despite the previously reported reduction of macrovascular disease risk in this cohort by metformin, linear mixed-effects regression modelling did not reveal evidence for an effect on cardiac troponin I and cardiac troponin T levels [− 8.4% (− 18.6, 3.2), p = 0.150, and − 4.6% (− 12, 3.2), p = 0.242, respectively]. A statistically significant time-treatment interaction was found for troponin T [− 1.6% (− 2.9, − 0.2), p = 0.021] but not troponin I concentrations [− 1.5% (− 4.2, 1.2), p = 0.263]. Conclusions: In this post-hoc analysis of a 4.3-year randomized controlled trial, metformin did not exert a clinically relevant effect on cardiac troponin I and cardiac troponin T levels when compared to placebo. Cardioprotective effects of the drug observed in clinical studies are not reflected by a reduction in these biomarkers of subclinical myocardial injury. Trial registration ClinicalTrials.gov identifier NCT00375388

Long term treatment with metformin in patients with type 2 diabetes and risk of vitamin B-12 deficiency: randomised placebo controlled trial

Objectives To study the effects of metformin on the incidence of vitamin B-12 deficiency (<150 pmol/l), low concentrations of vitamin B-12 (150-220 pmol/l), and folate and homocysteine concentrations in patients with type 2 diabetes receiving treatment with insulin

Finerenone in Predominantly Advanced CKD and Type 2 Diabetes With or Without Sodium-Glucose Cotransporter-2 Inhibitor Therapy

INTRODUCTION: FIDELIO-DKD (FInerenone in reducing kiDnEy faiLure and dIsease prOgression in Diabetic Kidney Disease) investigated the nonsteroidal, selective mineralocorticoid receptor (MR) antagonist finerenone in patients with CKD and type 2 diabetes (T2D). This analysis explores the impact of use of sodium-glucose cotransporter-2 inhibitor (SGLT-2i) on the treatment effect of finerenone. METHODS: Patients (N = 5674) with T2D, urine albumin-to-creatinine ratio (UACR) of 30 to 5000 mg/g and estimated glomerular filtration rate (eGFR) of 25 to <75 ml/min per 1.73 m(2) receiving optimized renin-angiotensin system (RAS) blockade were randomized to finerenone or placebo. Endpoints were change in UACR and a composite kidney outcome (time to kidney failure, sustained decrease in eGFR ≥40% from baseline, or renal death) and key secondary cardiovascular outcomes (time to cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for heart failure) (ClinicalTrials.gov, NCT02540993). RESULTS: Of 5674 patients, 259 (4.6%) received an SGLT-2i at baseline. Reduction in UACR with finerenone was found with or without use of SGLT-2i at baseline, with ratio of least-squares means of 0.69 (95% CI = 0.66–0.71) and 0.75 (95% CI -= 0.62–0.90), respectively (P(interaction) = 0.31). Finerenone also significantly reduced the kidney and key secondary cardiovascular outcomes versus placebo; there was no clear difference in the results by SGLT-2i use at baseline (P(interaction) = 0.21 and 0.46, respectively) or at any time during the trial. Safety was balanced with or without SGLT-2i use at baseline, with fewer hyperkalemia events with finerenone in the SGLT-2i group (8.1% vs. 18.7% without). CONCLUSION: UACR improvement was observed with finerenone in patients with CKD and T2D already receiving SGLT-2is at baseline, and benefits on kidney and cardiovascular outcomes appear consistent irrespective of use of SGLT-2i

Combination of insulin and metformin in the treatment of type 2 diabetes

WSTĘP. Celem pracy była ocena działania metabolicznego metforminy w porównaniu z placebo, u chorych na cukrzycę typu 2, leczonych według schematu intensywnej insulinoterapii. MATERIAŁ I METODY. Metformina poprawia kontrolę glikemii u osób ze źle wyrównaną cukrzycą typu 2. Dotychczas nie zbadano jej wpływu u chorych na cukrzycę typu 2, leczonych metodą intensywnej insulinoterapii. Grupa 390 chorych na cukrzycę typu 2, stosujących insulinę, uczestniczyła w randomizowanym, kontrolowanym, przeprowadzonym metodą podwójnie ślepej próby badaniu z zaplanowaną pośrednią analizą po 16 tygodniach leczenia. Uczestników badania wybrano z 3 przyszpitalnych przychodni i losowo przydzielono do grup, przyjmujących placebo lub metforminę w uzupełnieniu insulinoterapii. Podczas badania prowadzono intensywną kontrolę glikemii z natychmiastowym dostosowaniem dawki insuliny, zgodnie ze ścisłymi wytycznymi. Określano wskaźniki kontroli glikemii, zapotrzebowanie na insulinę, masę ciała, ciśnienie tętnicze, stężenie lipidów, incydenty hipoglikemii i inne działania niepożądane. WYNIKI. Sposród 390 osób 37 nie ukończyło badania (12 w grupie otrzymującej placebo i 25 w grupie leczonej metforminą). U osób, które ukończyły 16-tygodniowy okres leczenia zastosowanie metforminy w porównaniu z placebo powodowało poprawę kontroli glikemii (średnia glikemia podczas 16 tygodni 7,8 vs. 8,8 mmol/l, p = 0,006; średnie stężenie HbA1c 6,9 vs. 7,6%, p < 0,0001), zmniejszone zapotrzebowanie na insulinę (63,8 vs. 71,3 j.; p < 0,0001), mniejszy przyrost masy ciała (-0,4 vs. +1,2 kg; p < 0,01) i zmniejszenie stężenia cholesterolu frakcji LDL (-0,21 vs. -0,02 mmol/l; p < 0,01). Ryzyko wystąpienia hipoglikemii było podobne. WNIOSKI. U chorych na cukrzycę typu 2, leczonych intensywnie insuliną, skojarzenie insuliny z metforminą powoduje lepsze wyrównanie glikemii w porównaniu z monoterapią insuliną, a jednocześnie zmniejsza zapotrzebowanie na insulinę i ogranicza przyrost masy ciała.INTRODUCTION. To investigate the metabolic effects of metformin, as compared with placebo, in type 2 diabetic patients intensively treated with insulin. MATERIAL AND METHODS. Metformin improves glycemic control in poorly controlled type 2 diabetic patients. Its effect in type 2 diabetic patients who are intensively treated with insulin has not been studied. A total of 390 patients whose type 2 diabetes was controlled with insulin therapy completed a randomized controlled double-blind trial with a planned interim analysis after 16 weeks of treatment.The subjects were selected from three outpatient clinics in regional hospitals and were randomly assigned to either the placebo or metformin group, in addition to insulin therapy. Intensive glucose monitoring with immediate insulin adjustments according to strict guidelines was conducted. Indexes of glycemic control, insulin requirements, body weight, blood pressure, plasma lipids, hypoglycemic events, and other adverse events were measured. RESULTS. Of the 390 subjects, 37 dropped out (12 in the placebo and 25 in the metformin group). Of those who completed 16 weeks of treatment, metformin use, as compared with placebo, was associated with improved glycemic control (mean daily glucose at 16 weeks 7.8 vs. 8.8 mmol/l, P = 0.006; mean GHb 6.9 vs. 7.6%, P < 0.0001); reduced insulin requirements (63.8 vs. 71.3 IU, P < 0.0001); reduced weight gain (&#8211;0.4 vs. +1.2 kg, P < 0.01); and decreased plasma LDL cholesterol (&#8211;0.21 vs. &#8211;0.02 mmol/l, P < 0.01). Risk of hypoglycemia was similar in both groups. CONCLUSIONS. In type 2 diabetic patients who are intensively treated with insulin, the combination of insulin and metformin results in superior glycemic control compared with insulin therapy alone, while insulin requirements and weight gain are less