Dataset Information

Effectiveness of a dietician-led intervention in reducing glycated haemoglobin among people with type 2 diabetes in Nepal: a single centre, open-label, randomised controlled trial.

ABSTRACT:

Background

Nutrition education and counselling are considered a cornerstone for the management of type 2 diabetes (T2D). However, there is limited research related to the management of T2D through dietary approach, particularly in low-income and middle-income countries (LMICs) like Nepal. This study assessed the effectiveness of a dietician-led dietary intervention in reducing glycated haemoglobin (HbA1c) levels among people with T2D.

Methods

An open-label, two-armed, hospital-based, randomised controlled trial was conducted at Tribhuvan University Teaching Hospital, Kathmandu, Nepal. Participants were randomly assigned to either dietician-led dietary intervention group (n = 78) or usual care control group (n = 78). People with type 2 diabetes with HbA1c >6.5% and aged 24-64 years were included in the study. The primary outcome was a change in HbA1c level over six months, and secondary outcomes included changes in biochemical and clinical parameters, Problem Areas in Diabetes (PAID) score, diabetic knowledge, dietary adherence, and macronutrient intake level. Data were analysed using an intention-to-treat approach. This trial is registered with ClinicalTrials.gov, NCT04267367.

Findings

Between August 15, 2021 and February 25, 2022, 156 people with type 2 diabetes were recruited for the study, of which 136 participants completed the trial. At six months of follow-up, compared to baseline values, the mean HbA1c (%) level decreased in the intervention group by 0.48 (95% CI: -0.80 to -0.16), while it increased in the control group by 0.22 (95% CI: -0.21 to 0.66). In an adjusted model, the reduction in HbA1c (%) levels for the intervention was 0.61 (95% CI: -1.04 to -0.17; p = 0.006). In addition, fasting blood glucose was decreased by 18.96 mg/dL (95% CI: -36.12 to -1.81; p = 0.031) after the intervention. The intervention resulted in the reduction of BMI, waist and hip circumference, PAID score, dietary adherence, and macronutrient intake in the intervention group compared to the control group.

Interpretation

The dietician-led intervention improved glycaemic control, improved macronutrient intake, and clinical outcomes among people with type 2 diabetes. The dietician-led intervention may be considered for diabetes management in LMICs.

Funding

The research was funded by the University Grants Commission (UGC), Nepal.

SUBMITTER: Sunuwar DR

PROVIDER: S-EPMC10667281 | biostudies-literature | 2023 Nov

REPOSITORIES: biostudies-literature

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Effectiveness of a dietician-led intervention in reducing glycated haemoglobin among people with type 2 diabetes in Nepal: a single centre, open-label, randomised controlled trial.

Sunuwar Dev Ram DR Nayaju Suvash S Dhungana Raja Ram RR Karki Kshitij K Singh Pradhan Pranil Man PM Poudel Pramod P Nepal Chitrakala C Thapa Madhu M Shakya Nani Shobha NS Sayami Matina M Shrestha Pradip Krishna PK Yadav Renu R Singh Devendra Raj DR

The Lancet regional health. Southeast Asia 20230925

<h4>Background</h4>Nutrition education and counselling are considered a cornerstone for the management of type 2 diabetes (T2D). However, there is limited research related to the management of T2D through dietary approach, particularly in low-income and middle-income countries (LMICs) like Nepal. This study assessed the effectiveness of a dietician-led dietary intervention in reducing glycated haemoglobin (HbA1c) levels among people with T2D.<h4>Methods</h4>An open-label, two-armed, hospital-bas ...[more]

PMID: 38028163

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Project description:BackgroundBecause treatment with third-generation cephalosporins is associated with slow clinical improvement and high relapse burden for enteric fever, whereas the fluoroquinolone gatifloxacin is associated with rapid fever clearance and low relapse burden, we postulated that gatifloxacin would be superior to the cephalosporin ceftriaxone in treating enteric fever.MethodsWe did an open-label, randomised, controlled, superiority trial at two hospitals in the Kathmandu valley, Nepal. Eligible participants were children (aged 2-13 years) and adult (aged 14-45 years) with criteria for suspected enteric fever (body temperature ≥38·0°C for ≥4 days without a focus of infection). We randomly assigned eligible patients (1:1) without stratification to 7 days of either oral gatifloxacin (10 mg/kg per day) or intravenous ceftriaxone (60 mg/kg up to 2 g per day for patients aged 2-13 years, or 2 g per day for patients aged ≥14 years). The randomisation list was computer-generated using blocks of four and six. The primary outcome was a composite of treatment failure, defined as the occurrence of at least one of the following: fever clearance time of more than 7 days after treatment initiation; the need for rescue treatment on day 8; microbiological failure (ie, blood cultures positive for Salmonella enterica serotype Typhi, or Paratyphi A, B, or C) on day 8; or relapse or disease-related complications within 28 days of treatment initiation. We did the analyses in the modified intention-to-treat population, and subpopulations with either confirmed blood-culture positivity, or blood-culture negativity. The trial was powered to detect an increase of 20% in the risk of failure. This trial was registered at ClinicalTrials.gov, number NCT01421693, and is now closed.FindingsBetween Sept 18, 2011, and July 14, 2014, we screened 725 patients for eligibility. On July 14, 2014, the trial was stopped early by the data safety and monitoring board because S Typhi strains with high-level resistance to ciprofloxacin and gatifloxacin had emerged. At this point, 239 were in the modified intention-to-treat population (120 assigned to gatifloxacin, 119 to ceftriaxone). 18 (15%) patients who received gatifloxacin had treatment failure, compared with 19 (16%) who received ceftriaxone (hazard ratio [HR] 1·04 [95% CI 0·55-1·98]; p=0·91). In the culture-confirmed population, 16 (26%) of 62 patients who received gatifloxacin failed treatment, compared with four (7%) of 54 who received ceftriaxone (HR 0·24 [95% CI 0·08-0·73]; p=0·01). Treatment failure was associated with the emergence of S Typhi exhibiting resistance against fluoroquinolones, requiring the trial to be stopped. By contrast, in patients with a negative blood culture, only two (3%) of 58 who received gatifloxacin failed treatment versus 15 (23%) of 65 who received ceftriaxone (HR 7·50 [95% CI 1·71-32·80]; p=0·01). A similar number of non-serious adverse events occurred in each treatment group, and no serious events were reported.InterpretationOur results suggest that fluoroquinolones should no longer be used for treatment of enteric fever in Nepal. Additionally, under our study conditions, ceftriaxone was suboptimum in a high proportion of patients with culture-negative enteric fever. Since antimicrobials, specifically fluoroquinolones, are one of the only routinely used control measures for enteric fever, the assessment of novel diagnostics, new treatment options, and use of existing vaccines and development of next-generation vaccines are now a high priority.FundingWellcome Trust and Li Ka Shing Foundation.

Project description:BackgroundEffective control of hypertension remains challenging in low and middle-income countries. We tested the effectiveness of comprehensive approaches to hypertension management including six home visits by community health workers with regular follow up by a trained healthcare provider on blood pressure levels in Nepal.MethodsWe implemented a non-blinded, open-label, parallel-group, two-arm cluster randomised controlled trial, with 1:1 allocation ratio in Budhanilakantha municipality, Kathmandu, Nepal. Ten public health facilities and their catchment area were randomly allocated to receive comprehensive intervention or only usual hypertension care. We recruited 1252 individuals aged 18 years and older with hypertension. The primary outcome was systolic blood pressure. Secondary outcomes were diastolic blood pressure, proportion with controlled blood pressure, waist to hip ratio, body mass index, physical activity, diet quality score, daily salt intake, adherence to antihypertensives, hypertension knowledge and perceived social support. Primary analysis was by intention-to-treat using a linear mixed model.FindingsParticipants were, on average 57 years old, 60% females, 84% married, 54% Brahmin/Chettri ethnicity and 33% were illiterate. The decrease in mean systolic blood pressure (1.7 mm Hg, 95% CI -0.1, 3.4) and diastolic blood pressure (1.6 mm Hg, 95% CI 0.5, 2.6) was more in the intervention arm compared to the control. The proportion with blood pressure control (OR 1.5 95% CI 1.0, 2.1) and engaging in adequate physical activity (≥600 Metabolic equivalents of task per week) (OR 2.2, 95% CI 1.6, 3.1) were higher in the intervention arm compared to control. The change in hypertension knowledge score was higher and daily salt intake was lower in the intervention arm compared to control. Waist to hip ratio increased more and global dietary requirement scores decreased more in the intervention group and there was no effect on the body mass index and adherence to antihypertensives.InterpretationCommunity health workers facilitated home support and routine follow-up care by healthcare providers was effective in controlling blood pressure in urban Nepal. These findings suggest comprehensive interventions targeting individual, community and health system barriers are feasible in low resource settings, but larger implementation trials are needed to inform future scale-up.FundingThis work was supported by Norwegian University of Science and Technology, Trondheim, Norway (Project number 981023100).

Project description:BACKGROUND:Glucose management is challenging in patients who require nutritional support in hospital. We aimed to assess whether fully closed-loop insulin delivery would improve glycaemic control compared with conventional subcutaneous insulin therapy in inpatients receiving enteral or parenteral nutrition or both. METHODS:We did a two-centre (UK and Switzerland), open-label, randomised controlled trial in adult inpatients receiving enteral or parenteral nutrition (or both) who required subcutaneous insulin therapy. Patients recruited from non-critical care surgical and medical wards were randomly assigned (1:1) using a computer-generated minimisation schedule (stratified by type of nutritional support [parenteral nutrition on or off] and pre-study total daily insulin dose [<50 or ≥50 units]) to receive fully closed-loop insulin delivery with faster-acting insulin aspart (closed-loop group) or conventional subcutaneous insulin therapy (control group) given in accordance with local clinical practice. Continuous glucose monitoring in the control group was masked to patients, ward staff, and investigators. Patients were followed up for a maximum of 15 days or until hospital discharge. The primary endpoint was the proportion of time that sensor glucose concentration was in target range (5·6-10·0 mmol/L), assessed in the intention-to-treat population. This trial is registered with ClinicalTrials.gov, number NCT01774565. FINDINGS:Between Feb 8, 2018, and Sept 21, 2018, 90 patients were assessed for eligibility, of whom 43 were enrolled and randomly assigned to the closed-loop group (n=21) or the control group (n=22). The proportion of time that sensor glucose was in the target range was 68·4% [SD 15·5] in the closed-loop group and 36·4% [26·6] in the control group (difference 32·0 percentage points [95% CI 18·5-45·5; p<0·0001]). One serious adverse event occurred in each group (one cardiac arrest in the control group and one episode of acute respiratory failure in the closed-loop group), both of which were unrelated to study interventions. There were no adverse events related to study interventions in either group. No episodes of severe hypoglycaemia or hyperglycaemia with ketonaemia occurred in either study group. INTERPRETATION:Closed-loop insulin delivery is an effective treatment option to improve glycaemic control in patients receiving nutritional support in hospital. FUNDING:Diabetes UK, Swiss National Science Foundation, National Institute for Health Research Cambridge Biomedical Research Centre, Wellcome Trust, and European Foundation for the Study of Diabetes.

Project description:IntroductionFibromyalgia syndrome (FMS) is defined as a medical condition with chronic widespread musculoskeletal pain accompanied by mood disorders, fatigue and sleep disturbances. Treatment of this condition can often be challenging. As nutrition in general and nutritional interventions in the context of illness management become more and more important, current research also focuses on the relevance of diets for FMS, including gluten as field of interest. To date, there is no clear evidence that a gluten-free diet or other nutritional interventions are significantly important for the reduction of pain in the context of FMS. Only a very few studies show that FMS patients respond to a gluten-free diet and that cytokine production (also in FMS) can be reduced through the change. However, these studies have not investigated whether and to what extent cognitive factors, such as the expectation of symptom reduction triggered by diet, play a role. Recent research shows that treatment expectation plays an important role in the course of the disease and in the effectiveness of treatment approaches. For example, there are promising pain treatment options using open-label placebos (OLPs), which show that expectation alone, rather than the pharmacological substance of medication, can reduce pain experience. In our study protocol, we hypothesise that treatment expectation can be positively influenced by the given information regarding the placebos, resulting in improved treatment outcomes for pain and indigestions.Methods and analysisIn this trial, patients with FMS will undergo a food challenge and take an OLP (patients will be informed about the placebo), followed by a 3-week OLP treatment. The subjects will be randomised into four groups: (a) gluten-free porridge+neutral OLP instructions; (b) gluten-free porridge+positive OLP instructions; (c) gluten-containing porridge+neutral OLP instructions and (d) gluten-containing porridge+positive OLP instructions. Patients will be recruited via different institutions and support groups in Hamburg. The inclusion criteria are (a) diagnosed FMS, (b) absence of wheat allergy, coeliac disease or pain-related red flags and (c) being a minimum age of 18 years. The study requires 100 subjects to assess the primary outcomes: pain intensity and occurence of indigestion. Secondary outcomes are functional capacity, treatment expectation, and different pain-related and inflammation-related blood parameters. The measure time points will be before and after the food challenge and before and after the 3-week OLP treatment.Ethics and disseminationEthical approval was obtained in October 2021 from the Hamburg Medical Ethics Council. The results of the study will be disseminated through publications, presentations and conference meetings.Trial registration numberGerman Clinical Trials Register (DRKS; DRKS00027130).

Project description:AimsThere is rising healthcare utilization related to the increasing incidence and prevalence of atrial fibrillation (AF) worldwide. Simplifying therapy and reducing hospital episodes would be a valuable development. The efficacy of a streamlined AF ablation approach was compared to drug therapy and a conventional catheter ablation technique for symptom control in paroxysmal AF.Methods and resultsWe recruited 321 patients with symptomatic paroxysmal AF to a prospective randomized, multi-centre, open label trial at 13 UK hospitals. Patients were randomized 1:1:1 to cryo-balloon ablation without electrical mapping with patients discharged same day [Ablation Versus Anti-arrhythmic Therapy for Reducing All Hospital Episodes from Recurrent (AVATAR) protocol]; optimization of drug therapy; or cryo-balloon ablation with confirmation of pulmonary vein isolation and overnight hospitalization. The primary endpoint was time to any hospital episode related to treatment for atrial arrhythmia. Secondary endpoints included complications of treatment and quality-of-life measures. The hazard ratio (HR) for a primary endpoint event occurring when comparing AVATAR protocol arm to drug therapy was 0.156 (95% CI, 0.097-0.250; P < 0.0001 by Cox regression). Twenty-three patients (21%) recorded an endpoint event in the AVATAR arm compared to 76 patients (74%) within the drug therapy arm. Comparing AVATAR and conventional ablation arms resulted in a non-significant HR of 1.173 (95% CI, 0.639-2.154; P = 0.61 by Cox regression) with 23 patients (21%) and 19 patients (18%), respectively, recording primary endpoint events (P = 0.61 by log-rank test).ConclusionThe AVATAR protocol was superior to drug therapy for avoiding hospital episodes related to AF treatment, but conventional cryoablation was not superior to the AVATAR protocol. This could have wide-ranging implications on how demand for AF symptom control is met.Trial registrationClinical Trials Registration: NCT02459574.

Dataset Information

Effectiveness of a dietician-led intervention in reducing glycated haemoglobin among people with type 2 diabetes in Nepal: a single centre, open-label, randomised controlled trial.

Background

Methods

Findings

Interpretation

Funding

Publications

Effectiveness of a dietician-led intervention in reducing glycated haemoglobin among people with type 2 diabetes in Nepal: a single centre, open-label, randomised controlled trial.

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