Exercise in newly diagnosed patients with multiple myeloma: A randomized controlled trial of effects on physical function, physical activity, lean body mass, bone mineral density, pain, and quality of life.

Reduced physical function caused by bone destruction, pain, anemia, infections, and weight loss is common in multiple myeloma (MM). Myeloma bone disease challenges physical exercise. Knowledge on the effects and safety of physical exercise in newly diagnosed patients with MM is limited.

Quality of life, patient satisfaction, and cardiovascular outcomes of the randomised 2 x 3 factorial Copenhagen insulin and Metformin therapy (CIMT) trial - A detailed statistical analysis plan.

Background: The evidence on the effects of metformin and insulin in type 2 diabetes patients on quality of life, patient satisfaction, and cardiovascular outcomes is unclear.

Methods: The Copenhagen Insulin and Metformin Therapy (CIMT) trial is an investigator-initiated multicentre, randomised, placebo-controlled trial with a 2 × 3 factorial design conducted at eight hospitals in Denmark. Participants with type 2 diabetes were randomised to metformin (n = 206) versus placebo (n = 206); in combination with open-label biphasic insulin aspart one to three times daily (n = 137) versus insulin aspart three times daily in combination with insulin detemir once daily (n = 138) versus insulin detemir once daily (n = 137).

Effects of 18-months metformin versus placebo in combination with three insulin regimens on RNA and DNA oxidation in individuals with type 2 diabetes: A post-hoc analysis of a randomized clinical trial.

Formation of reactive oxygen species has been linked to the development of diabetes complications. Treatment with metformin has been associated with a lower risk of developing diabetes complications, including when used in combination with insulin. Metformin inhibits Complex 1 in isolated mitochondria and thereby decreases the formation of reactive oxygen species.

Effect of metformin and insulin vs. placebo and insulin on whole body composition in overweight patients with type 2 diabetes: a randomized placebo-controlled trial.

Unlabelled: Some studies indicate potential beneficial effects of metformin on body composition and bone. This trial compared metformin + insulin vs placebo + insulin. Metformin treatment had a small but positive effect on bone quality in the peripheral skeleton, reduced weight gain, and resulted in a more beneficial body composition compared with placebo in insulin-treated patients with type 2 diabetes.

Prediction of carotid intima-media thickness and its relation to cardiovascular events in persons with type 2 diabetes.

Aims: To investigate measures of carotid intima-media thickness (IMT) and conventional cardiovascular (CV) risk factors as predictors of future carotid IMT, and the prediction of CV events during follow-up based on measures of carotid IMT.

Methods: Observational longitudinal study including 230 persons with type 2 diabetes (T2D).

Results: Mean age at follow-up was 66.

Effect of Metformin vs. Placebo in Combination with Insulin Analogues on Bone Markers P1NP and CTX in Patients with Type 2 Diabetes Mellitus.

Preclinical studies have shown a potential osteoanabolic effect of metformin but human studies of how metformin affects bone turnover are few. A post hoc sub-study analysis of an 18-month multicenter, placebo-controlled, double-blinded trial in type 2 diabetes mellitus (T2DM), randomizing participants to metformin versus placebo both in combination with different insulin analogue regimens (Metformin + Insulin vs. Placebo + Insulin).

The effect of metformin versus placebo in combination with insulin analogues on bone mineral density and trabecular bone score in patients with type 2 diabetes mellitus: a randomized placebo-controlled trial.

Unlabelled: Some antihyperglycemic medications have been found to affect bone metabolism. We assessed the long-term effects of metformin compared with placebo on bone mineral density (BMD) and trabecular bone score (TBS) in patients with type 2 diabetes. Metformin had no significant effect on BMD in the spine and hip or TBS compared with a placebo.

Effects of biphasic, basal-bolus or basal insulin analogue treatments on carotid intima-media thickness in patients with type 2 diabetes mellitus: the randomised Copenhagen Insulin and Metformin Therapy (CIMT) trial.

Objective: To assess the effect of 3 insulin analogue regimens on change in carotid intima-media thickness (IMT) in patients with type 2 diabetes.

Design And Setting: Investigator-initiated, randomised, placebo-controlled trial with a 2 × 3 factorial design, conducted at 8 hospitals in Denmark.

Participants And Interventions: Participants with type 2 diabetes (glycated haemoglobin (HbA1c) ≥ 7.

Metformin versus placebo in combination with insulin analogues in patients with type 2 diabetes mellitus-the randomised, blinded Copenhagen Insulin and Metformin Therapy (CIMT) trial.

Objective: To assess the effect of metformin versus placebo both in combination with insulin analogue treatment on changes in carotid intima-media thickness (IMT) in patients with type 2 diabetes.

Design And Setting: Investigator-initiated, randomised, placebo-controlled trial with a 2 × 3 factorial design conducted at eight hospitals in Denmark.

Participants And Interventions: 412 participants with type 2 diabetes (glycated haemoglobin (HbA1c) ≥ 7.

Bilateral primary adrenal lymphoma presenting with adrenal insufficiency.

Lymphoma may occasionally involve the adrenal glands, but primary adrenal lymphoma (PAL) is very rare and only few cases have been reported. We present a case of a 60-year-old, otherwise healthy, woman, with bilateral PAL presenting with adrenal insufficiency. The patient responded initially upon administration of large doses of intravenously hydrocortisone with total remission of symptoms.

Metabolic syndrome in a cohort of affectively ill patients, a naturalistic study.

Background: Patients with affective disorder have higher mortality not only because of their affective illness but also because of a higher risk of death from physical illness especially cardiovascular diseases.

Aim: To investigate the prevalence in a naturalistic cohort of patient treated at a Mood Disorder Clinic.

Methods: Patients were evaluated for the presence of metabolic syndrome (MeS) according to modified NCEP ATP III criteria.

Prevalence of the metabolic syndrome in Danish psychiatric outpatients treated with antipsychotics.

Background: The incidence of the metabolic syndrome, a major risk factor for diabetes and cardiovascular disease, is increasing worldwide and is suggested to be higher among psychiatric patients, especially those on antipsychotic treatment.

Aims: To assess the prevalence of the metabolic syndrome in Danish psychiatric outpatients and compare it with the general population.

Methods: In a cross-sectional, observational study in 2007-08, 170 Danish outpatients on antipsychotic drug treatment were monitored for the prevalence of the metabolic syndrome based on the International Diabetes Federation (IDF) definition and compared with a general population group of 3303 randomly selected Danes.

[Abdominal obesity and associated comorbidities among primary care patients].

Introduction: Abdominal obesity is associated with type 2 diabetes, cardiovascular disease, dyslipidemia and hypertension. The prevalence of abdominal obesity and its relationship with these comorbidities have not previously been examined in Danish primary care patients.

Material And Methods: The IDEA study was an international cross sectional study including 168,159 patients worldwide.

[The effect of tesofensine on body weight and body composition in obese subjects--secondary publication].

Results from a phase II trial with Tesofensine for treatment of obesity are presented. In total 203 obese persons were randomised to treatment with Tesofensine 0.25, 0.

Study rationale and design of the CIMT trial: the Copenhagen Insulin and Metformin Therapy trial.

Background: Patients with type 2 diabetes (T2DM) have an increased mortality rate primarily because of macrovascular disease. Where T2DM patients cannot be managed sufficiently through diet, exercise and peroral antidiabetic drugs, that is when haemoglobin A1c (HbA1c) is above 7.0%, it is yet unknown whether a combination of metformin and insulin analogues is superior to insulin analogues alone.

Initiating or switching to biphasic insulin aspart 30/70 therapy in subjects with type 2 diabetes mellitus. An observational study.

Objective: To investigate tolerability and glycemic control over 26 weeks in patients with type 2 diabetes (T2D) who initiated insulin with, or switched to, biphasic insulin aspart 30/70 (BIAsp 30) in routine clinical care.

Methods: This was a non-randomized, non-interventional, open-label, observational study involving patients under the care of approximately 150 insulin-prescribing physicians in Denmark. All patients enrolled were prescribed BIAsp 30 in routine care.

Effect of tesofensine on bodyweight loss, body composition, and quality of life in obese patients: a randomised, double-blind, placebo-controlled trial.

Background: Weight-loss drugs produce an additional mean weight loss of only 3-5 kg above that of diet and placebo over 6 months, and more effective pharmacotherapy of obesity is needed. We assessed the efficacy and safety of tesofensine-an inhibitor of the presynaptic uptake of noradrenaline, dopamine, and serotonin-in patients with obesity.

Methods: We undertook a phase II, randomised, double-blind, placebo-controlled trial in five Danish obesity management centres.

3-Month Results from Denmark within the Globally Prospective and Observational Study to Evaluate Insulin Detemir Treatment in Type 1 and Type 2 Diabetes: The PREDICTIVE Study.

PREDICTIVEtrade mark is a large, multi-national, open-label, prospective, observational study to assess the efficacy and safety of insulin detemir in clinical practice. We report 3-month follow-up data from 389 patients with type 1 (n = 312) and type 2 (n = 77) diabetes from Denmark. Insulin detemir improved glycemic control in type 1 patients, with decreases in mean HbA1c (-0.

Lemierre's syndrome: still an important clinical entity.

We report a case of Lemierre's syndrome caused by Fusobacterium necrophorum and discuss characteristics of this potentially fatal condition which, though rare, may have a rising frequency. Familiarity with the signs and symptoms of Lemierre's syndrome is therefore of great importance.

[Drug treatment of obesity].

Acceptable adverse effects and a clinical relevant weight loss of 3 to 5 kilograms have been found in long-term randomized clinical trials for sibutramine (Reductil) and orlistat (Xenical); these drugs may be prescribed for treatment of obesity for a duration of one and four years, respectively. This also seems to be the case for rimonabant (Acomplia), which is expected to receive approval in 2005 or 2006. However, until data on morbidity and mortality are available from RCTs, there is no absolute indication for prescribing drugs for treatment of obesity.

Chronic meningococcaemia.

Chronic meningococcaemia is a rare disorder. A patient was admitted to hospital with intermittent fever and arthralgia of a migratory nature for 1 week. Maculopapular lesions were present.

Twenty-four-hour plasma tryptophan concentrations and ratios are below normal in obese subjects and are not normalized by substantial weight reduction.

Background: Plasma tryptophan concentrations and the ratio of tryptophan to other large neutral amino acids (plasma tryptophan ratio) are reportedly low in obese subjects. The plasma tryptophan ratio predicts brain tryptophan uptake and serotonin production. If this ratio is low in obese subjects, serotonin function may also be low.

Prolonged QTc interval predicts mortality in patients with Type 1 diabetes mellitus.

Aims: To evaluate prolonged QTc interval and QT dispersion as predictors of all-cause and cardiovascular mortality after adjustment for well-established risk factors in Type 1 diabetic patients.

Methods: From a cohort of all adult Type 1 diabetic patients, duration of diabetes >or= 5 years, attending the clinic in 1984 and followed in an observational study for 10 years (n = 939), all subjects with resting baseline electrocardiograms were identified (n = 697, 360 males). The QT length was measured and corrected for heart rate (QTc).