A micro-costing analysis of nutritional support for persons with TB and their families in India.

Undernutrition is the leading risk factor for TB infection and death in India. We undertook a micro-costing analysis of a nutritional intervention for household contacts of people living with TB in Puducherry, India. We found that the total 6-month food cost for a family of four was USD4/day. We also identified several alternative regimens and cost-lowering strategies to encourage wider adoption of nutritional supplementation as a public health tool.

La sous-nutrition est le principal facteur de risque d'infection et de décès dus à la TB en Inde. Nous avons entrepris une analyse de micro-coût d'une intervention nutritionnelle destinée aux contacts familiaux des personnes atteintes de la TB à Puducherry, en Inde. Nous avons constaté que le coût total de la nourriture pendant 6 mois pour une famille de quatre personnes était de 4 USD par jour. Nous avons également identifié plusieurs régimes alternatifs et stratégies de réduction des coûts pour encourager une adoption plus large de la supplémentation nutritionnelle en tant qu'outil de santé publique.

Effect of a multicomponent intervention on achievement and improvements in quality-of-care indices among people with Type 2 diabetes in South Asia: the CARRS trial.

AIMS: To evaluate whether and what combinations of diabetes quality metrics were achieved in a multicentre trial in South Asia evaluating a multicomponent quality improvement intervention that included non-physician care coordinators to promote adherence and clinical decision-support software to enhance physician practices, in comparision with usual care. METHODS: Using data from the Centre for Cardiometabolic Risk Reduction in South Asia (CARRS) trial, we evaluated the proportions of trial participants achieving specific and combinations of five diabetes care targets (HbA1c <53 mmol/mol [7%], blood pressure <130/80 mmHg, LDL cholesterol <2.6 mmol/L, non-smoking status, and aspirin use). Additionally, we examined the proportions of participants achieving the following risk factor improvements from baseline: ≥11-mmol/mol (1%) reduction in HbA1c , ≥10-mmHg reduction in systolic blood pressure, and/or ≥0.26-mmol/l reduction in LDL cholesterol. RESULTS: Baseline characteristics were similar in the intervention and usual care arms. Overall, 12.3%, 29.4%, 36.5%, 19.5% and 2.2% of participants in the intervention group and 16.2%, 38.3%, 31.6%, 11.3% and 0.8% of participants in the usual care group achieved any one, two, three, four or five targets, respectively. We noted sizeable improvements in HbA1c , blood pressure and cholesterol, and found that participants in the intervention group were twice as likely to achieve improvements in all three indices at 12 months that were sustained over 28 months of the study [relative risk 2.1 (95% CI 1.5,2.8) and 1.8 (95% CI 1.5,2.3), respectively]. CONCLUSIONS: The intervention was associated with significantly higher achievement of and greater improvements in composite diabetes quality care goals. However, among these higher-risk participants, very small proportions achieved the complete group of targets, which suggests that achievement of multiple quality-of-care goals is challenging and that other methods may be needed in closing care gaps.

Acromegaloidism Associated with Pituitary Incidentaloma.

Acromegaloidism with pituitary microadenoma has not been previously reported. We present a case of a 28-year old male with typical features of acromegaly for 11 years.with a pituitary tumor. He had characteristic acromegaloid facial features, clubbing of hands and feet, enlargement of fingers and toes. The natural history of the disease is reviewed and the differential diagnosis is discussed.

Effect of insulin degludec versus sitagliptin in patients with type 2 diabetes uncontrolled on oral antidiabetic agents.

AIM: The efficacy and safety of insulin degludec (IDeg), a new basal insulin with an ultra-long duration of action, was compared to sitagliptin (Sita) in a 26-week, open-label trial. METHODS: Insulin-naïve subjects with type 2 diabetes [n = 458, age: 56 years, diabetes duration: 7.7 years, glycosylated haemoglobin (HbA1c): 8.9% (74 mmol/mol)] were randomized (1 : 1) to once-daily IDeg or Sita (100 mg orally) as add-on to stable treatment with 1 or 2 oral antidiabetic drugs (OADs). RESULTS: Superiority of IDeg to Sita in improving HbA1c and fasting plasma glucose (FPG) was confirmed [estimated treatment difference (ETD) IDeg-Sita for HbA1c: -0.43%-points [95% confidence interval (CI): -0.61; -0.24, p < 0.0001] and for FPG: -2.17 mmol/l (95% CI: -2.59; -1.74, p < 0.0001)]. HbA1c < 7% (<53 mmol/mol) was achieved by 41% (IDeg) versus 28% (Sita) of patients, estimated odds ratio IDeg/Sita: 1.60 (95% CI: 1.04; 2.47, p = 0.034). There was no statistically significant difference in the rate of nocturnal confirmed hypoglycaemia between IDeg and Sita [0.52 vs. 0.30 episodes/patient-year, estimated rate ratio (ERR): IDeg/Sita: 1.93 (95% CI: 0.90; 4.10, p = 0.09)]. Rates of overall confirmed hypoglycaemia were higher with IDeg than with Sita [3.1 vs. 1.3 episodes/patient-year, ERR IDeg/Sita: 3.81 (95% CI: 2.40; 6.05, p < 0.0001)]. IDeg was associated with a greater change in body weight than Sita [ETD IDeg-Sita: 2.75 kg (95% CI: 1.97; 3.54, p < 0.0001)]. The overall rates of adverse events were low and similar for both groups. CONCLUSIONS: In patients unable to achieve good glycaemic control on OAD(s), treatment intensification with IDeg offers an effective, well-tolerated alternative to the addition of a second or third OAD.

A multicentre, multinational, randomized, placebo-controlled, double-blind, phase 3 trial to evaluate the efficacy and safety of gemigliptin (LC15-0444) in patients with type 2 diabetes.

AIM: This study was designed to assess the efficacy and safety of the dipeptidyl peptidase IV inhibitor gemigliptin (LC15-0444) 50 mg versus placebo in patients with type 2 diabetes. METHODS: We conducted a 24-week, randomized, double-blind, placebo-controlled phase III trial in 182 patients (74 from Korea and 108 from India) with type 2 diabetes. After an initial 2 weeks of a diet and exercise programme followed by 2 weeks of a single-blind placebo run-in period, eligible patients were randomized to gemigliptin 50 mg or placebo, receiving the assigned treatment for 24 weeks. HbA1c and fasting plasma glucose (FPG) were measured periodically, and oral glucose tolerance test was performed at baseline and weeks 12 and 24. RESULTS: At week 24, gemigliptin treatment led to significant reductions in HbA1c measurements compared to placebo (adjust mean after subtracting the placebo effect size: -0.71%, 95% confidence interval: -1.04 to -0.37%). A significantly greater proportion of patients achieved an HbA1c <7% with gemigliptin than with placebo. The placebo-subtracted FPG change from baseline at week 24 was -19.80 mg/dl. The overall incidence rates for adverse events were similar in the gemigliptin and placebo groups. CONCLUSIONS: This study showed the efficacy and safety of gemigliptin 50 mg administered once daily as a monotherapy for type 2 diabetes patients.

Triple oral fixed-dose diabetes polypill versus insulin plus metformin efficacy demonstration study in the treatment of advanced type 2 diabetes (TrIED study-II).

AIM: To compare the efficacy of a fixed-dose triple oral diabetes polypill containing 1 or 2 mg glimepiride, 500 mg sustained-release metformin, and 15 mg pioglitazone (GMP) administered once daily with human insulin 70/30 mix and 500 mg sustained-release metformin administered twice daily (IM) in insulin-naÏve subjects with type 2 diabetes mellitus inadequately controlled [haemoglobin A1c (HbA1c) over 8.0%] on a combination of glimepiride and metformin. METHODS: One hundred and one subjects were randomized to GMP or IM regimens for 12 weeks. The primary outcome was the change in HbA1c and secondary outcomes were changes in fasting plasma, and postprandial plasma glucoses and the number of patients achieving a drop in HbA1c of over 1%. Other secondary outcomes were changes in the lipid profile, C-peptide level, body weight as well as physician assessments of efficacy and patient assessment of tolerability. RESULTS: The primary outcome of a change in HbA1c showed a trend towards a lower HbA1c with GMP therapy (-1.33% vs. -0.83%; p = 0.059). The number of subjects achieving a decrease in HbA1c of greater than 1.0% was significantly greater in the GMP therapy (72.5% vs. 22%; p = 0.0001). Both regimens equally and significantly reduced fasting and postprandial glucose levels (p = 0.05). Weight gain was nonsignificantly greater with IM (2.69 vs. 0.92 kg; p = 0.223). Investigator assessment of efficacy was significantly better with GMP (p = 0.001) as was tolerability as assessed by patients (p = 0.0001). CONCLUSION: When compared with suboptimally titrated IM there was a trend towards a lower HbA1c with GMP and significantly more GMP subjects obtained an HbA1c under 7%. Global assessments by investigators and subjects showed both a greater efficacy and tolerability with GMP.

A randomized, treat-to-target trial comparing insulin lispro protamine suspension and insulin detemir in insulin-naive patients with Type 2 diabetes.

AIMS: Insulin lispro protamine suspension (ILPS) and insulin detemir were compared in insulin-naive patients with Type 2 diabetes poorly controlled by oral glucose-lowering agents (OGLAs) to demonstrate non-inferior overall glycaemic control. METHODS: This was a 24-week, multinational, open-label, parallel-group, treat-to-target trial. Adults taking two or more OGLAs were randomized to ILPS (n = 223) or detemir (n = 219) once daily at bedtime. Doses were titrated to target fasting blood glucose (FBG) 5.0-7.2 mmol/l. A pre-breakfast dose was added up to week 8 per prespecified criteria. The primary objective was comparison of glycated haemoglobin (HbA(1c)) change from baseline (non-inferiority margin 0.4%). RESULTS: At end-point, HbA(1c) decreased from 8.8 +/- 0.7% in both groups to 7.3 +/- 0.9% (ILPS) and 7.5 +/- 1.1% (detemir). Least-squares mean difference (95% confidence interval) for HbA(1c) [-0.21% (-0.39, -0.03)] and glycaemic variability [0.10 mmol/l (-0.02, 0.23)] demonstrated non-inferiority. End-point mean FBG was 7.0 vs. 6.9 mmol/l (P = 0.85), and percentages of patients achieving H < 7.0% were 34.9% vs. 31.2% for ILPS vs. detemir. More ILPS patients used twice-daily dosing (59% vs. 49%). Mean daily insulin dose was 0.39 vs. 0.46 U/kg (P = 0.005) and weight gain was 1.88 vs. 0.36 kg (P < 0.001) for ILPS vs. detemir. Overall hypoglycaemia (episodes patient(-1) year(-1)) (24.2 +/- 33.0 vs. 16.2 +/- 26.1, P = 0.001) and nocturnal (6.3 +/- 12.1 vs. 3.8 +/- 13.2, P < 0.001) rates were higher for ILPS. CONCLUSIONS: At end-point, ILPS was non-inferior to detemir in HbA(1c) change from baseline. Patients using ILPS achieved lower end-point HbA(1c) with lower insulin doses but greater hypoglycaemia and weight gain.

Study Protocol: insulin and its role in cancer.

BACKGROUND: Studies have shown that metabolic syndrome and its consequent biochemical derangements in the various phases of diabetes may contribute to carcinogenesis. A part of this carcinogenic effect could be attributed to hyperinsulinism. High levels of insulin decrease the production of IGF-1 binding proteins and hence increase levels of free IGF-1. It is well established that bioactivity of free insulin growth factor 1 (IGF-1) increases tumor turnover rate. The objective is to investigate the role of insulin resistance/sensitivity in carcinogenesis by studying the relation between insulin resistance/sensitivity and IGF-1 levels in cancer patients. We postulate that hyperinsulinaemia which prevails during initial phases of insulin resistance (condition prior to overt diabetes) increases bioactivity of free IGF-1, which may contribute to process of carcinogenesis. METHODS/DESIGN: Based on our pilot study results and power analysis of the same, we have designed a two group case-control study. 800 proven untreated cancer patients (solid epithelial cell tumors) under age of 50 shall be recruited with 200 healthy subjects serving as controls. Insulin resistance/sensitivity and free IGF-1 levels shall be determined in all subjects. Association between the two parameters shall be tested using suitable statistical methods. DISCUSSION: Well controlled studies in humans are essential to study the link between insulin resistance, hyperinsulinaemia, IGF-1 and carcinogenesis. This study could provide insights to the role of insulin, insulin resistance, IGF-1 in carcinogenesis although a precise role and the extent of influence cannot be determined. In future, cancer prevention and treatment strategies could revolve around insulin and insulin resistance.

Tuberculosis of the spine-the Sabah experience. Epidemiology, treatment and results.

A retrospective review of 33 patients with tuberculosis of the spine from January 2000 to April 2002 revealed that the mean age was 36.5 and peak incidence is in the second decade of life (27.3%). There were 24 males and 9 females. The majority of the lesions involved the thoracic spine (30.3%), followed by the lumbar spine (27.2%). Skip lesions was seen in 12.1% of cases. The erythrocyte sedimentation rate was normal in 9.1% of patients. Neurological involvement was seen in 51.5% of patients. Concomitant tuberculosis of the lung was 66.6%. The radical surgical debridement and grafting rate was 39.3%. The preferred surgical procedure was that of radical anterior debridement and fusion supplemented by anterior or posterior instrumentation if needed. Anti-tuberculous chemotherapy remained the mainstay of treatment. Surgery gives faster relief of pain and neurological recovery but is a major undertaking, and thus selection of patients is vital to avoid morbidity and mortality.

Adrenal tumor presenting as precocious puberty.

We present a case report of a two and a half-year-old boy who presented with precocious puberty. A clinical diagnosis of congenital adrenal hyperplasia was made. Patient was investigated and found to have an adrenocortical tumor. The tumor was about 7 cms in diameter. The tumor was secreting androgens, 17OHP and cortisol. This is an unusual array of hormones to be secreted by an adrenal tumor.

Plaque form of pretibial myxedema in hypothyroidism.

Pretibial myxoedema presenting as a diffuse plaque form is being reported in a hypothyroid patient.