Background Following reports of anti-retroviral therapy (ART) experienced Ugandan people living with HIV (PLHIV) presenting with diabetic ketoacidosis weeks to months following a switch to dolutegravir (DTG), the Uganda Ministry of Health recommended withholding DTG in both ART naïve and experienced PLHIV with diabetes mellitus (T2DM), as well as 3-monthly blood glucose monitoring for patients with T2DM risk factors. We sought to determine if the risk of T2DM is indeed heightened in nondiabetic ART naïve Ugandan PLHIV over the first 48 weeks on DTG. Methods Between January and October 2021, 243 PLHIV without T2DM were initiated on DTG based ART for 48 weeks. Two-hour oral glucose tolerance tests (2-h OGTT) were performed at baseline, 12, and 36 weeks; fasting blood glucose (FBG) was measured at 24 and 48 weeks. The primary outcome was the incidence of T2DM. Secondary outcomes included: incidence of pre-Diabetes Mellitus (pre-DM), median change in FBG from baseline to week 48 and 2-h blood glucose (2hBG) from baseline to week 36. Linear regression models were used to determine adjusted differences in FBG and 2hBG from baseline to weeks 48 and 36 respectively. Results The incidence of T2DM was 4 cases per 1000 PY (1/243) and pre-DM, 240 cases per 1000 person years (PY) (54/243). There was a significant increase in FBG from baseline to week 48 [median change from baseline (FBG): 3.6 mg/dl, interquartile range (IQR): − 3.6, 7.2, p-value (p) = 0.005] and significant reduction in 2hBG (2hBG: − 7.26 mg/dl, IQR: − 21.6, 14.4, p = 0.024) at week 36. A high CD4 count and increased waist circumference were associated with 2hBG increase at week 36. Conclusion We demonstrated a low incidence of T2DM in Ugandan ART-naïve patients receiving DTG. We also demonstrated that longitudinal changes in BG were independent of conventional risk factors of T2DM in the first 48 weeks of therapy. Restricting the use of dolutegravir in Ugandan ART naïve patients perceived to be high risk for diabetes mellitus may be unwarranted.
Whether integrase strand transfer inhibitors (INSTIs) are associated with a higher risk of incident type 2 diabetes mellitus (DM) than other antiretroviral therapies (ART) needs to be established.MEDLINE, Embase, Web of Science, and ClinicalTrials.gov registries were searched for studies published between 1 January 2000 and 15 June 2022. Eligible studies reported incident DM or mean changes in insulin resistance measured by Homeostatic Model for Insulin Resistance (HOMA-IR) in patients on INSTIs compared with other ARTs. We performed random-effects meta-analyses to obtain pooled relative risks (RRs) with 95% CIs.A total of 16 studies were pooled: 13 studies meta-analyzed for incident diabetes with a patient population of 72 404 and 3 for changes in HOMA-IR. INSTI therapy was associated with a lower risk of incident diabetes in 13 studies (RR 0.80, 95% CI 0.67 to 0.96, I2=29%), of which 8 randomized controlled trials demonstrated a 22% reduced risk (RR 0.88, 95% CI 0.81 to 0.96, I2=0%). INSTIs had a lower risk compared with non-nucleoside reverse transcriptase inhibitors (RR 0.75, 95% CI 0.63 to 0.89, I2=0%) but similar to protease inhibitor-based therapy (RR 0.78, 95% CI 0.61 to 1.01, I2=27%). The risk was lower in studies with longer follow-up (RR 0.70, 95% CI 0.53 to 0.94, I2=24%) and among ART-naïve patients (RR 0.78, 95% CI 0.65 to 0.94, I2=3%) but increased in African populations (RR 2.99, 95% CI 2.53 to 3.54, I2=0%).In conclusion, exposure to INSTIs was not associated with increased risk of DM, except in the African population. Stratified analyses suggested reduced risk among ART-naïve patients and studies with longer follow-up.International Prospective Register of Systematic Reviews (PROSPERO) registration number: CRD42021273040.
Background The aim of this study was to determine the prevalence and factors associated with microalbuminuria among newly diagnosed diabetic patients in Mulago National Referral Hospital, Uganda. Methods In this cross-sectional study conducted between June 2014 and January 2015, we collected information on patients' socio-demographics, biophysical profile, blood pressure, biochemical testing and echocardiographic findings using a pre-tested questionnaire. Bivariate and multivariate logistic regression analyses were used to investigate the association of several factors with microalbuminuria. Results Of the 175 patients recruited, males were 90(51.4%) and the mean age was 46±15 years. Majority of patients had type 2 DM 140 (80.0%) and the rest had type 1 DM 35 (20.0%). Mean glycated hemoglobin (HbA1C) was 13.9±5.3%. Mean duration of diabetes was 2 months. Prevalence of microalbuminuria was 47.4 % (95% CI: 40.0%-54.9%) overall. Pregnancy was associated with microalbuminuria (OR7.74[95%CI.1.01–76.47] P=0.050) while mild and moderate physical activity at work were inversely associated with microalbuminuria respectively (OR0.08[95%CI0.01–0.95] P=0.046) and (OR0.07[95%CI0.01–0.77] P=0.030). Conclusion Prevalence of microalbuminuria was high in this group. Physical activity at work may be protective against microalbuminuria and this calls for longitudinal studies. Early detection and management of microalbuminuria in diabetics may slow progression to overt diabetic nephropathy (DN).
Introduction Poeple living with HIV have higher prevalence of diabetes mellitus and metabolic perturbations compared to non-HIV populations. Diabetes and metabolic syndrome co-morbidities add significant burden to HIV care. Currently, WHO recommends integrase strand transfer inhibitors (INSTIs) as the first or second line therapy in people with HIV due to overall good tolerability and safety profile. However, whether INSTI use increases the risk of incident diabetes (with or without metabolic syndrome) compared to other anti-retroviral therapies (ART) is controversial. In this systematic review and meta-analysis, we aim to examine this risk in HIV-positive populations receiving INSTIs compared to other ART regimens (not containing INSTIs). Methods and analysis The study will be reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) statement and the Meta-analysis Of Observational Studies in Epidemiology (MOOSE) guidelines. This protocol adheres to the Standard Protocol Items for reporting systematic reviews and meta-analyses checklist. Eligibility criteria will be original peer-reviewed published articles and conference abstracts with no language or geographical restriction; that report the ocurrence of diabetes mellitus as a discrete outcome or part of metabolic syndrome, in adult PLWHIV receiving INSTIs compared to other ART regimens. PubMed/ Medline, Web of Science, Embase and Cochrane Database of Systematic Reviews will be searched from 1st- January-2000 to 31st—January-2022. Per our a priori, screening, inclusion and data extraction will be conducted separately by two investigators, and a senior researcher will be consulted in case of disagreement. The quality of included studies will be assessed by the Newcastle-Ottawa Scale (NOS) for cohort and case-control studies and the revised Cochrane risk-of-bias tool (ROB2) for randomized controlled trials. The quantitative synthesis of the study outcomes will be explored in different subgroups and sensitivity analyses. Meta regression will also be performed to further test the predictors of the outcome. Ethics and dissemination Ethical approval is waived as the study is a review of published litterature. The analyses will be presented in conferences and published as a scientific article. Trial registrartion PROSPERO registration number is; CRD42021273040.
Background Microalbuminuria is an early marker of nephropathy, cardiovascular diseases and severe ocular morbidity in adults with diabetes mellitus. This subclinical condition is associated with high morbidity and mortality. Microalbuminuria precedes the development of overt diabetic nephropathy by 10–14 years. At this stage, one can reverse diabetic nephropathy or prevent its progression. Unfortunately, tests to detect microalbuminuria in diabetics are not routinely done in Uganda. This study sought to determine the prevalence and factors associated with microalbuminuria among newly diagnosed diabetic patients in the National Referral Hospital in Uganda. Methods In this cross-sectional study conducted between June 2014 and January 2015, we recruited 175 newly diagnosed adult diabetic patients. Information on patients’ socio-demographics, biophysical profile, blood pressure measurement, biochemical testing and echocardiographic findings was obtained for all the participants using a pre-tested questionnaire. Microalbuminuria was defined as Albumin to Creatinine Ratio (ACR) between 30 and 299 mg/g. Bivariate and multivariate logistic regression analyses were used to investigate the association of several factors with microalbuminuria. Results Of the 175 patients recruited, males were 90 (51.4%) and the mean age was 46 ± 15 years. Majority of patients had type 2 DM 140 (80.0%) and the rest had type 1 DM 35 (20.0%). The mean HbA1C was 13.9 ± 5.3%. Mean duration of diabetes was 2 months. Prevalence of microalbuminuria was 47.4% (95% CI: 40.0%−54.9%) among all the patients that were assessed in the study. The independent factor associated with microalbuminuria was pregnancy (OR7.74[95% CI: 1.01–76.47] P = 0.050) while mild and moderate physical activity at work were inversely associated with microalbuminuria respectively (OR0.08[95% CI: 0.01–0.95] P = 0.046) and (OR0.07[95% CI: 0.01–0.77] P = 0.030). Conclusions Prevalence of microalbuminuria was high in this patient population of newly diagnosed diabetes mellitus. Pregnancy was positively associated with significant microalbuminuria while physical activity at work was inversely associated with microalbuminuria. Early detection and management of microalbuminuria in asymptomatic individuals may help in preventing deterioration in renal function and development of overt diabetic nephropathy and progression to ESRD.
Background:HIV is one of the most important risk factors of tuberculosis (TB)-related morbidity and mortality. Isoniazid preventive therapy (IPT) is recommended to prevent latent TB reactivation in patients with HIV. However, due to multiple therapies and comorbidities, these patients are predisposed to adverse drug reactions (ADRs) that lead to increased morbidity and mortality. The aim of this study was to determine the prevalence and associated factors of suspected IPT-linked ADRs in HIV-positive patients using IPT.Methods:A cross-sectional study was conducted between February and March 2020 at 3 regional referral hospitals (RRHs) in central Uganda. We sampled 660 HIV-positive patients aged 10 years or older who received IPT between July and December 2019 inclusive. Patients were interviewed using a pretested structured questionnaire, and their treatment records were reviewed. A modified Poisson regression model with clustered robust standard errors was used to identify factors associated with suspected IPT-linked ADRs.Results:The prevalence of the suspected ADRs was 51% (334 of the 660; 95% confidence interval [CI]: 18% to 83%). Patients self-reported 7-fold the number of suspected ADRs documented in the clinical files by the health care workers. Musculoskeletal symptoms were the most frequently experienced reaction (14%), followed by dizziness (13%) and peripheral neuropathy (11%). Serious suspected ADRs were experienced by 12% of the study participants; the most common were hepatotoxicity (26%), dizziness (23%), and neuropathy (17%). Female sex (aPR [adjusted prevalence ratio]: 0.92, 95% CI: = 0.88 to 0.95), study site (aPR: 1.09, 95% CI: = 1.09 to 1.18), level of education (aPR: 0.94, 95% CI: = 0.94 to 0.99), history of TB (aPR: 0.93, 95% CI: = 0.87 to 0.99), good IPT adherence (aPR: 1.16, 95% CI: = 1.05 to 1.29), and use of protease inhibitor (PI)-based antiretroviral therapy (aPR: 1.01, 95% CI: = 1.00 to 1.02) were significantly associated with suspected IPT-linked ADRs.Conclusion:The prevalence of suspected IPT-linked ADRs is high, and hepatotoxicity is the most commonly reported serious suspected ADR. Patients self-reported more suspected ADRs than those documented in clinical files by health care workers. Patient engagement could improve ADR detection and potentially strengthen the pharmacovigilance system. Patients with a high risk of ADR ought to be monitored regularly to enable early detection and management.
Background Cardiometabolic diseases are a leading cause of HIV-related morbidity and mortality, yet routine screening is not undertaken in high burden countries. We aimed to assess the prevalence and risk factors of the metabolic syndrome (MetS) and its components in adult Ugandan people living with HIV (PWH) initiating dolutegravir-based antiretroviral therapy (ART). Methods We conducted a cross-sectional study using baseline sociodemographic and clinical data of PWH aged ≥ 18 years enrolled in the GLUMED (Glucose metabolism changes in Ugandan HIV patients on Dolutegravir) Study from January to October 2021. MetS was defined as having ≥ 3 of the following: abdominal obesity, hypertension (HTN), hyperglycemia, elevated triglycerides and low high-density lipoprotein cholesterol. Multiple logistic regression was used to assess associations between potential risk factors and MetS and its components. Results 309 PWH were analyzed (100% ART-naive, 59.2% female, median age 31 years and median CD4 count 318 cells/mm3). The prevalence of MetS was 13.9%. The most common cardiometabolic condition was dyslipidemia (93.6%), followed by abdominal obesity (34.0%), hyperglycemia (18.4%), and HTN (8.1%). In adjusted analysis, MetS was associated with age > 40 years (adjusted odds ratio 3.33, 95% confidence interval 1.45-7.67) and CD4 count > 200 cells/mm3 (3.79, 1.23-11.63). HTN was associated with age > 40 years (2.96, 1.32-6.64), and dyslipidemia was associated with urban residence (4.99, 1.35-18.53). Conclusion Cardiometabolic risk factors were common in this young Ugandan cohort of PWH initiating dolutegravir-based ART, underscoring the need for programmatic implementation of surveillance and management of comorbidities in Uganda and similar settings.
BackgroundThe Masters in Internal Medicine at the Makerere University College of Health Sciences is based on a semester system with a blend of lectures and clinical work. The programme runs for 3 years with didactic lectures set mostly for mornings and clinical care thereafter. Anecdotal reports from attending physicians in the department highlighted clinical work time interruption by didactic lectures which was thought to limit postgraduate (PG) students’ clinical work time. We set out to evaluate the clinical learning environment and explore avenues to optimise clinical exposure time.MethodsBaseline data in form of time logs documenting first-year PG activities was collected by intern doctors without the awareness of the PGs. In addition, a PG and attending physician survey on PG ward performance was carried out. These data informed a root cause analysis from which an intervention to change the mode of lecture delivery from daily lecturers across the semester to a set of block lectures was undertaken. Postimplementation time logs and survey data were compared with the pre-intervention data.ResultsPost-intervention, during a period of 50 ward round observations, PGs missed 3/50 (6%) ward rounds as compared with 10/50 (20%) pre-intervention. PGs arrived on wards before attending physicians 18/24 (75%) times post-intervention and on average had 59 min to prepare for ward rounds as compared with 5/26 (19.2%) times and 30 min, respectively, pre-intervention. Both PGs and physicians believed PGs had enough time for patient care post-intervention (17/17 (100%) vs 4/17 (23.5%) and 7/8 (87.5%) vs 2/8 (25%)), respectively.ConclusionThe baseline data collected confirmed the anecdotal reports and a change to a block week lecture system led to improvements in PGs’ clinical work time and both resident and physician approvals of PG clinical work.
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