scholarly journals The iHealth-T2D study: rationale and design of a cluster randomised trial for prevention of Type 2 Diabetes amongst South Asians with central obesity and prediabetes

Author(s):  
Anuradhani Kasturiratne ◽  
Khadija I Khawaja ◽  
Sajjad Ahmad ◽  
Samreen Siddiqui ◽  
Khurram Shahzad ◽  
...  

AbstractBackgroundPeople from South Asia are at increased risk of type 2 diabetes (T2D). There is an urgent need to develop approaches for prevention of T2D in South Asians, that are cost-effective, generalisable and scalable across settings.HypothesisCompared to usual care, risk of T2D can be reduced amongst South Asians with central obesity or raised HbA1c, through a 12 month lifestyle modification programme delivered by community health workers.DesignCluster randomised clinical trial (1:1 allocation to Intervention or Usual care), carried out in India, Pakistan, Sri Lanka, and UK, with 30 sites per country (120 sites total). Target recruitment 3,600 (30 participants per site) with annual follow-up for three years.Entry criteriaSouth Asian, men or women, age 40-70 years with i. Central obesity (waist circumference ≥100cm in India and Pakistan; ≥90cm in Sri Lanka) and / or ii. Prediabetes (HbA1c 6.0-6.4% inclusive). Exclusion criteria: known type 1 or 2 diabetes, normal or underweight (body mass index<22kg/m2); pregnant or planning pregnancy; unstable residence or planning to leave the area; serious illness.EndpointsThe primary end point is new onset T2D at 3 years, defined as: i. HbA1c≥6.5% or ii. Physician diagnosis and on treatment for T2D. Secondary endpoints at 1 and 3 years are: i. Physical measures: waist circumference, weight and blood pressure; ii. Lifestyle measures: smoking status, alcohol intake, physical activity, dietary intake; iii. Biochemical measures: Fasting glucose, insulin and lipids (total and HDL cholesterol, triglycerides); and iv. Treatment compliance.InterventionLifestyle intervention (60 sites) or Usual care (60 sites). Lifestyle intervention was delivered by a trained community health worker over 12 months (5 one-one session, 4 group sessions, 13 telephone sessions) with the goal of the participants achieving e a 7% reduction in body mass index and a 10 cm reduction in waist circumference through i. improved diet and ii. increased physical activity. Usual care comprised a single 30 minute session of lifestyle modification advice from the community health worker.ResultsWe screened 33,212 people for inclusion into the study. We identified 10,930 people who met study entry criteria, amongst whom, 3,682 agreed to take part in the intervention. Study participants are 49.2% female and aged 52.8 (SD 8.2) years. Clinical characteristics are well balanced between Intervention and Usual care sites. More than 90% of follow-up visits are scheduled to be complete December 2020. Based on follow-up to end 2019, the observed incidence of T2D in the study population is in line with expectations (6.1% per annum).ConclusionThe iHealth-T2D study will advance understanding of strategies for prevention of diabetes amongst South Asians, use approaches for screening and intervention that are adapted for low-resource settings. Our study will thus inform the implementation of strategies for improving the health and well-being of this major global ethnic group.IRB approval16/WM/0171Trial registrationEudraCT 2016-001350-18. Registered 14 April 2016 https://www.hra.nhs.uk/planning-and-improving-research/application-summaries/research-summaries/ihealth-t2d/ ; ClinicalTrials.gov NCT02949739. Registered 31 October 2016, https://clinicaltrials.gov/ct2/show/NCT02949739, First posted 31/10/2016.FunderEuropean Commission (award 643774) and National Institute for Health Research (award 16/136/68)

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Anuradhani Kasturiratne ◽  
Khadija I. Khawaja ◽  
Sajjad Ahmad ◽  
Samreen Siddiqui ◽  
Khurram Shahzad ◽  
...  

Abstract Background People from South Asia are at increased risk of type 2 diabetes (T2D). There is an urgent need to develop approaches for the prevention of T2D in South Asians that are cost-effective, generalisable and scalable across settings. Hypothesis Compared to usual care, the risk of T2D can be reduced amongst South Asians with central obesity or raised HbA1c, through a 12-month lifestyle modification programme delivered by community health workers. Design Cluster randomised clinical trial (1:1 allocation to intervention or usual care), carried out in India, Pakistan, Sri Lanka and the UK, with 30 sites per country (120 sites total). Target recruitment 3600 (30 participants per site) with annual follow-up for 3 years. Entry criteria South Asian, men or women, age 40–70 years with (i) central obesity (waist circumference ≥ 100 cm in India and Pakistan; ≥90 cm in Sri Lanka) and/or (ii) prediabetes (HbA1c 6.0–6.4% inclusive). Exclusion criteria: known type 1 or 2 diabetes, normal or underweight (body mass index < 22 kg/m2); pregnant or planning pregnancy; unstable residence or planning to leave the area; and serious illness. Endpoints The primary endpoint is new-onset T2D at 3 years, defined as (i) HbA1c ≥ 6.5% or (ii) physician diagnosis and on treatment for T2D. Secondary endpoints at 1 and 3 years are the following: (i) physical measures: waist circumference, weight and blood pressure; (ii) lifestyle measures: smoking status, alcohol intake, physical activity and dietary intake; (iii) biochemical measures: fasting glucose, insulin and lipids (total and HDL cholesterol, triglycerides); and (iv) treatment compliance. Intervention Lifestyle intervention (60 sites) or usual care (60 sites). Lifestyle intervention was delivered by a trained community health worker over 12 months (5 one-one sessions, 4 group sessions, 13 telephone sessions) with the goal of the participants achieving a 7% reduction in body mass index and a 10-cm reduction in waist circumference through (i) improved diet and (ii) increased physical activity. Usual care comprised a single 30-min session of lifestyle modification advice from the community health worker. Results We screened 33,212 people for inclusion into the study. We identified 10,930 people who met study entry criteria, amongst whom 3682 agreed to take part in the intervention. Study participants are 49.2% female and aged 52.8 (SD 8.2) years. Clinical characteristics are well balanced between intervention and usual care sites. More than 90% of follow-up visits are scheduled to be complete in December 2020. Based on the follow-up to end 2019, the observed incidence of T2D in the study population is in line with expectations (6.1% per annum). Conclusion The iHealth-T2D study will advance understanding of strategies for the prevention of diabetes amongst South Asians, use approaches for screening and intervention that are adapted for low-resource settings. Our study will thus inform the implementation of strategies for improving the health and well-being of this major global ethnic group. IRB approval 16/WM/0171 Trial registration EudraCT 2016-001350-18. Registered on 14 April 2016. ClinicalTrials.govNCT02949739. Registered on 31 October 2016, First posted on 31/10/2016.


2020 ◽  
Author(s):  
Mirthe Muilwijk ◽  
Marie Loh ◽  
Sara Mahmood ◽  
Saranya Palaniswamy ◽  
Samreen Siddiqui ◽  
...  

AbstractBackgroundSouth Asians are at high risk of type 2 diabetes (T2D). Lifestyle modification is effective at preventing T2D amongst South Asians, but the approaches to screening and intervention are limited by high-costs, poor scalability and thus low impact on T2D burden. An intensive family-based lifestyle modification programme for prevention of T2D was developed. The aim of the iHealth-T2D trial is to compare the effectiveness of this programme with usual care.MethodsThe iHealth-T2D trial is designed as a cluster randomised controlled trial (RCT) conducted at 120 locations across India, Pakistan, Sri Lanka and the UK. A total of 3,682 South Asian men and women with age between 40-70 years without T2D but at elevated risk for T2D [defined by central obesity (waist circumference ≥95cm in Sri Lanka, or ≥100cm in India, Pakistan and UK) and/or prediabetes (HbA1c ≥6.0%)] were included in the trial. Here we describe in detail the statistical analysis plan (SAP), which was finalised before outcomes were available to the investigators. The primary outcome will be evaluated after three years of follow-up after enrolment to the study, and is defined as T2D incidence in the intervention arm compared to usual care. Secondary outcomes are evaluated both after one and three years of follow-up and include biochemical measurements, anthropometric measurements, behavioural components and treatment compliance.DiscussionThe iHealth-T2D trial will provide evidence whether an intensive family-based lifestyle modification programme in South Asians who are at high risk for T2D is effective in the prevention of T2D. The data from the trial will be analysed according to this pre-specified SAP.Ethics and disseminationThe trial was approved by the international review board of each participating study site. Study findings will be disseminated through peer-reviewed publications and in conference presentations.Trial registrationEudraCT 2016-001350-18. Registered 14 April 2016 https://www.hra.nhs.uk/planning-and-improving-research/application-summaries/research-summaries/ihealth-t2d/; ClinicalTrials.govNCT02949739. Registered 31 October 2016, https://clinicaltrials.gov/ct2/show/NCT02949739, First posted 31/10/2016.


2020 ◽  
Vol 2020 ◽  
pp. 1-12 ◽  
Author(s):  
Oliver Okoth Achila ◽  
Millen Ghebretinsae ◽  
Abraham Kidane ◽  
Michael Simon ◽  
Shewit Makonen ◽  
...  

Objective. There is a dearth of relevant research on the rapidly evolving epidemic of diabetes mellitus (particularly Type 2 diabetes mellitus) in sub-Saharan Africa. To address some of these issues in the Eritrean context, we conducted a cross-sectional study on glycemic and lipid profiles and associated risk factors. Methods. A total of 309 patients with diabetes mellitus on regular follow-up at the Diabetic and Hypertensive Department at Halibet Regional Referral Hospital, Asmara, were enrolled for the study. Data on specific clinical chemistry and anthropomorphic parameters was collected. Chi-squared (χ2) test or Fischer’s exact test was used to evaluate the relationship between specific variables. Multivariate logistic regression (backward: conditional) was undertaken to identify the factors associated with increased odds of suboptimal values in glucose and specific lipid panel subfractions. Results. High proportions of patients (76.7%) had suboptimal levels of HbA1c with a mean±SD of 8.6%±1.36, respectively. In multivariate regression analysis, the likelihood of HbA1c≥7% was higher in patients with abnormal WHR (AOR=3.01, 95% CI, 3.01 (1.15–7.92=0.024)) and in patients without hypertension (AOR=1.97, 95% CI (1.06–3.56), p=0.021). A unit reduction in eGFR was also associated with HbA1c≥7% (AOR=0.99, 95% CI (0.98–1=0.031)). In a separate analysis, the data shows that 80.9% of the patients had dyslipidemia. In particular, 62.1% of the patients had TC≥200 mg/dL (risk factors: sex, hypertension, and HbA1c concentration), 81.6% had LDL‐C≥100 mg/dL (risk factors: sex and hypertension), 56.3% had TG≥150 (risk factors: sex, HbA1c, and waist circumference), 62.8% had abnormal HDL-C (risk factors: waist circumference), 78.3% had non‐HDL<130 mg/dL (risk factors: duration of disease, reduced estimated glomerular filtration rate, and HbA1c), and 45.3% had abnormal TG/HDL (risk factors: sex, age of patient, FPG, and waist circumference). Conclusions. The quality of care, as measured by glycemic and specific lipid targets, in this setting is suboptimal. Therefore, there is an urgent need for simultaneous improvements in both indicators. This will require evidence-based optimization of pharmacological and lifestyle interventions. Therefore, additional studies, preferably longitudinal studies with long follow-up, are required on multiple aspects of DM.


Author(s):  
Catherine W. Gathu ◽  
Jacob Shabani ◽  
Nancy Kunyiha ◽  
Riaz Ratansi

Background: Diabetes self-management education (DSME) is a key component of diabetes care aimed at delaying complications. Unlike usual care, DSME is a more structured educational approach provided by trained, certified diabetes educators (CDE). In Kenya, many diabetic patients are yet to receive this integral component of care. At the family medicine clinic of the Aga Khan University Hospital (AKUH), Nairobi, the case is no different; most patients lack education by CDE.Aim: This study sought to assess effects of DSME in comparison to usual diabetes care by family physicians.Setting: Family Medicine Clinic, AKUH, Nairobi.Methods: Non-blinded randomised clinical trial among sub-optimally controlled (glycated haemoglobin (HbA1c) ≥ 8%) type 2 diabetes patients. The intervention was DSME by CDE plus usual care versus usual care from family physicians. Primary outcome was mean difference in HbA1c after six months of follow-up. Secondary outcomes included blood pressure and body mass index.Results: A total of 220 diabetes patients were screened out of which 140 met the eligibility criteria and were randomised. Around 96 patients (69%) completed the study; 55 (79%) in the DSME group and 41 (59%) in the usual care group. The baseline mean age and HbA1c of all patients were 48.8 (standard deviation [SD]: 9.8) years and 9.9% (SD: 1.76%), respectively. After a 6-month follow-up, no significant difference was noted in the primary outcome (HbA1c) between the two groups, with a mean difference of 0.37 (95% confidence interval: -0.45 to 1.19; p = 0.37). DSME also made no remarkable change in any of the secondary outcome measures.Conclusion: From this study, short-term biomedical benefits of a structured educational approach seemed to be limited. This suggested that offering a short, intensified education programme might have limited additional benefit above and beyond the family physicians’ comprehensive approach in managing chronic conditions like diabetes.


2012 ◽  
Vol 2012 ◽  
pp. 1-7 ◽  
Author(s):  
D. E. Barre ◽  
K. A. Mizier-Barre ◽  
E. Stelmach ◽  
J. Hobson ◽  
O. Griscti ◽  
...  

Aim. Animal and human study evidence supports the hypothesis that flaxseed lignan complex (FLC) at a dose of 600 mg secoisolariciresinol diglucoside (SDG)/day for three months would combat hyperglycaemia, dyslipidemia, blood pressure, central obesity, prothrombotic state, inflammation, and low density lipoprotein (LDL) oxidation.Methods. Sixteen type 2 diabetic patients completed this double-blind, randomised crossover placebo-controlled study. A univariate repeated measures analysis of covariance (significanceP<0.05) was followed by a mixed linear model effects analysis corrected for multiple comparisons (MCC).Results. Prior to MCC, FLC caused decreased fasting plasma glucose, A1c, inflammation (c-reactive protein (CRP) and interleukin-6 (IL-6)), and increased bleeding time. After correction for multiple comparisons, FLC induced a statistically significant increase in bleeding time and smaller waist circumference gain. No treatment effect occurred in the other variables before or after adjustment.Conclusions. It is concluded that FLC significantly increased bleeding time thus reducing the prothrombotic state, reduced central obesity gain as measured by waist circumference, and did not affect significantly the other dependent variables measured after adjustment for multiple comparisons. These findings, not yet published in human type 2 diabetes, suggest that this FLC dose over at least three months, may, subject to further investigation, reduce polypharmacy.


Author(s):  
Eva Sulistiowati ◽  
Marice Sihombing

Abstrak Prediabetes merupakan kondisi gula darah puasa 100-125mg/dL (Impaired Fasting Glucose/IFG) atau kadar gula darah 2 jam setelah pembebanan 75 g glukosa 140-199 mg/dL (Impaired Glucose Tolerance/IGT). Prediabetes meningkatkan risiko terjadinya Diabetes Mellitus tipe 2 (DM tipe 2). Tujuan analisis ini untuk mengetahui terjadinya DM Tipe 2 pada responden dengan prediabetes dalam follow-up 2 tahun. Prospektif studi dalam 2 tahun pada 3344 responden Studi Kohor Faktor Risiko PTM non-DM tipe 2. Data yang dikumpulkan meliputi wawancara, pemeriksaan fisik (BB, TB, lingkar perut, tekanan darah), dan laboratorium (GDP, GDPP, Kolesterol total, HDL, LDL, Trigliserida). Kadar glukosa darah untuk DM Tipe 2 dan prediabetes mengacu pada kriteria ADA 2011. Analisis deskriptif tentang karakteristik, life tabel perkembangan DM Tipe 2 dari prediabetes. Prediabetes yang terjadi sebesar 24,6% (IFG 2,3%; IGT 19,2% dan mix IFG/IGT 2,8%) dan 13,4% mengalami DM tipe 2 dalam kurun waktu 2 tahun. Progresivitas terjadinya DM dari IFG, IGT dan mix TGTmasing-masing 6,21; 6,12 dan 14,6 per 100 orang per tahun. Faktor risiko yang mempengaruhi terjadinya DM tipe 2 antara lain: umur (40-54 tahun RR=1,97; CI 95%:1,02-3,82), 55-65 tahun (RR=2,74; CI 95%: 1,34-5,58), obesitas sentral (RR=4,42; CI 95%: 2,36-8,29), hipertensi (RR= 1,99; CI 95%: 1,29-3,06) dan hipertrigliserida (RR=1,83; CI 95%: 1,18-2,83). Proporsi prediabetes dan terjadinya DM tipe 2 di Bogor Tengah dalam pengamatan 2 tahun, meningkat dengan bertambahnya umur dan dipengaruhi oleh obesitas sentral, hipertensi, hipertrigliserida. Pengendalian faktor risiko dan pemeriksaan gula darah secara rutin dapat mencegah terjadinya DM tipe 2. Perlu ditunjang dengan posbindu PTM aktif di masyarakat, lingkungan kerja maupun sekolah. Kata kunci: Prediabetes, Diabetes Melitus tipe 2 (DM tipe 2), Bogor Tengah Abstract Prediabetes is a condition that fasting plasma glucose 100-125 mg/dL (Impaired Fasting Glucose/IFG) or blood glucose 2 hours after loading 75 g glucose 140-199 mg/dL (Impaired Glucose Tolerance/IGT). Prediabetes increases the risk of type 2 Diabetes Mellitus (T2DM). This analysis is to determine the progression rate to T2DM in prediabetes respondents during 2 years follow up. This is an two years prospective study in 3344 respondents Cohort Study of Risk Factors NCD without T2DM. The data collected included interviews, physical examination (body weight, height, abdominal circumference, blood pressure), and laboratory (fasting plasma glucose/FPG, plasma glucose 2 hours after loading 75 g glucose, total cholesterol, HDL, LDL, triglycerides). Blood glucose levels for DM and prediabetes refers to ADA criteria 2011. Data analisized by descriptive about characteristics, life table of T2DM development from prediabetes. Prediabetes occurred at 24.6% (IFG 2.3%, IGT 19.2% and mix IFG / IGT 2.8%) and 13.4% experienced type 2 diabetes within 2 years. The progression of DM from IFG, IGT and mix TGT is 6.21; 6.12 and 14,6 per 100 person per year respectively. The risk factors of T2DM are age (40-54 years old (RR=1,97; CI 95%:1,02-3,82), 55-65 years old (RR=2,74; CI 95%:1,34-5,58), central obesity (RR=4,42; CI 95%:2,36-8,29), hypertension (RR=1,99; CI 95%:1,29-3,06) and hypertriglyceride (RR=1,83; CI 95%:1,18-2,83). The proportion of prediabetes and progression T2DM in Central Bogor at 2 years follow up is quite high, increasing with age and influenced by central obesity, hypertension and hypertriglyceride. Controlling risk factors and checking blood glucose regularly can prevent T2DM. Need to be supported by posbindu PTM active in the community, work environment and school. Keywords: Prediabetes, type 2 Diabetes Mellitus (T2DM), Central Bogor


2020 ◽  
Author(s):  
Zhen Ling Ong ◽  
Nishi Chaturvedi ◽  
Therese Tillin ◽  
Caroline Dale ◽  
Victoria Garfield

Objective: The risk of developing type 2 diabetes associated with poor sleep quality is comparable to that of traditional risk factors (e.g. overweight, physical inactivity). In the United Kingdom, these traditional risk factors could not explain the two to three-fold excess risks in South Asian and African Caribbean men compared to Europeans. This study investigates the (i)the association between mid-life sleep quality and later-life type 2 diabetes risk and (ii)a potential modifying effect of ethnicity. Research Design and Methods: The Southall and Brent REvisited (SABRE) cohort comprised Europeans, South Asians, and African Caribbeans (median follow-up = 19 years). Complete case analysis was performed on 2190 participants without diabetes at baseline (age= 51.7 ± 7SD). Competing risks regressions were used to estimate the hazard ratios (HRs) of developing type 2 diabetes associated with four self-reported baseline sleep exposures (difficulty falling asleep, early morning waking, waking up tired and snoring) while adjusting for confounders. Modifying effects of ethnicity were analysed by (i) testing for interactions and (ii) performing ethnicity-stratified analysis. Results: Snoring was strongly associated with increased type 2 diabetes risk but only among South Asians in a fully-adjusted model (HR 1.42, 95%CI=1.08-1.85, P=0.011). Our results revealed no elevated risk for any of the sleep exposures across all three ethnic groups. Conclusions: The association between snoring and type 2 diabetes appeared to be modified by ethnicity, with South Asians at greatest risk.


2018 ◽  
Vol 2018 ◽  
pp. 1-9 ◽  
Author(s):  
Yongwen Zhang ◽  
Lanfang Chu

Background. Health education is considered to be essential in the overall care of patients with type 2 diabetes mellitus (T2DM); systematic health education integrates individual education not only during hospitalization but also extended care outside of a hospital. To test effectiveness of the systematic health education model for T2DM, we conducted a randomized study with a control group among patients with T2DM living in Nanjing, China. Methods. 998 eligible patients completed the enrollment and were randomized to systematic health education model and conventional model groups (498 and 500 patients, resp.). The systematic health education model was based on the following aspects: image education, visitation of the exhibition hall, dissemination of educational materials, individualized medical nutrition therapy and exercise programs, WeChat group and regular health lectures, evaluation of complications, lifestyle modification, systematic treatment scheme, self-monitoring of glycemic control, monthly evaluation of the therapeutic effect, proposed improvement measures, and individualized follow-up scheme. The main outcome measures were glycated hemoglobin A1c (HbA1c), blood pressure, body mass index (BMI), and lipids during the 2-year follow-up. Results. The systematic health education model led to a favorable variation in HbA1c, LDL cholesterol, and systolic blood pressure (SBP) (P<0.05). After adjusted analysis, the HbA1c decreased by 0.67% (P<0.01) in the systematic health education model, SBP decreased by 10.83 mmHg (P<0.01), and the level of diastolic blood pressure (DBP), HDL cholesterol, and total cholesterol decreased slightly and was not significant. The BMI did not change significantly during the study in either of the two groups. Conclusions. The systematic health education model is a useful method in the treatment of T2DM because it contributes to decrease in HbA1c, LDL cholesterol, and SBP levels, as well as helps in increasing the compliance with the control criteria, except for DBP and BMI.


2021 ◽  
pp. 1-8
Author(s):  
Júlia Marchetti ◽  
Karla P. Balbino ◽  
Helen Hermana M. Hermsdorff ◽  
Leidjaira L. Juvanhol ◽  
José Alfredo Martinez ◽  
...  

<b><i>Introduction:</i></b> Single nucleotide polymorphisms (SNP) in the fat mass and obesity-associated (<i>FTO</i>) gene have been associated with type 2 diabetes (T2D) and its complications. The aim of the present research was to investigate which and how (directly or indirectly) clinical and metabolic variables mediate the association between fat mass and the <i>FTO</i> gene and early chronic kidney disease (CKD) in individuals with T2D. <b><i>Methods:</i></b> This cross-sectional study was conducted in a sample of 236 participants with T2D (53.4% women, mean age 60 ± 10 years). DNA samples were genotyped for the rs7204609 polymorphism (C/T) in the <i>FTO</i> gene. Clinical, anthropometric, and metabolic data were collected. Path analysis was used to evaluate the associations. <b><i>Results:</i></b> Of the sample, 78 individuals with T2D had CKD (33%). Presence of the risk allele (<i>C</i>) was higher among participants with CKD (21.8 vs. 10.8%; <i>p</i> = 0.023). This polymorphism was positively associated with higher waist circumference, which in turn was associated with higher glycated hemoglobin and higher blood pressure. A higher blood-pressure level was associated with higher urinary albumin excretion (UAE) and as expected, higher UAE was associated with CKD. Path analysis showed an indirect relationship between the <i>FTO</i> gene and early CKD, mediated by waist circumference, blood-pressure levels, and UAE. <b><i>Conclusions:</i></b> These findings suggest that the <i>C</i> allele may contribute to genetic susceptibility to CKD in individuals with T2D through the presence of central obesity, hypertension, and high albuminuria.


Sign in / Sign up

Export Citation Format

Share Document