Dataset Information

DIABRISK-SL prevention of cardio-metabolic disease with life style modification in young urban Sri Lankan's--study protocol for a randomized controlled trial.

ABSTRACT:

Background

Urban South-Asian's are predisposed to early onset of type 2 diabetes mellitus (T2DM) and cardiovascular disease (CVD). There is an urgent need for country specific primary prevention strategies to address the growing burden of cardio-metabolic disease in this population. The aim of this clinical trial is to evaluate whether intensive (3-monthly) lifestyle modification advice is superior to a less-intensive (12 monthly; control group) lifestyle modification advice on a primary composite cardio-metabolic end point in 'at risk' urban subjects aged between 5-40 years.

Methods/design

This is an open randomised controlled parallel group clinical trial performed at a single centre in Colombo, Sri-Lanka. A cluster sampling strategy was used to select a large representative sample of subjects aged between 5-40 years at high risk of T2DM and CVD for the intervention study. We have screened 23,298 (males 47% females 53%) healthy subjects for four risk factors: obesity, elevated waist circumference, family history of diabetes and physical inactivity, using a questionnaire and anthropometry. Those with two or more risk-factors were recruited to the intervention trial. We aim to recruit 4600 subjects for the intervention trial. The primary composite cardio-metabolic end point is; new onset T2DM, impaired glucose tolerance, impaired fasting glycaemia, new onset hypertension and albuminuria, following 5 years of intervention. The effect of the intervention on pre-specified secondary endpoints will also be evaluated. The study will be conducted according to good clinical and ethical practice, data analysis and reporting guidelines.

Discussion

DIABRISK-SL is a large population based trial to evaluate the prevalence of diabetes, pre-diabetes and cardio-metabolic risk factors among young urban Sri-Lankans and the effect of a primary prevention strategy on cardio-metabolic disease end points. This work will enable country specific and regional cardio-metabolic risk scores to be derived. Further if the proposed intervention is successful the results of this study can be translated and implemented as a low-cost primary prevention tool in Sri-Lanka and other low/middle income developing countries.

Trial registration

The trial is registered with the World Health Organisation and Sri-Lanka clinical trial registry number SLCTR/2008/003.

SUBMITTER: Wijesuriya M

PROVIDER: S-EPMC3197497 | biostudies-literature | 2011 Sep

REPOSITORIES: biostudies-literature

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Publications

DIABRISK-SL prevention of cardio-metabolic disease with life style modification in young urban Sri Lankan's--study protocol for a randomized controlled trial.

Wijesuriya Mahen M Gulliford Martin M Vasantharajah Laksha L Viberti Giancarlo G Gnudi Luigi L Karalliedde Janaka J

Trials 20110926

<h4>Background</h4>Urban South-Asian's are predisposed to early onset of type 2 diabetes mellitus (T2DM) and cardiovascular disease (CVD). There is an urgent need for country specific primary prevention strategies to address the growing burden of cardio-metabolic disease in this population. The aim of this clinical trial is to evaluate whether intensive (3-monthly) lifestyle modification advice is superior to a less-intensive (12 monthly; control group) lifestyle modification advice on a primary ...[more]

PMID: 21943067

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Project description:BackgroundThere is an increasing incidence of type 2 diabetes mellitus (T2DM) in young urban South-Asians. We tested the effect of a pragmatic trimonthly lifestyle modification (LSM) programme (P-LSM) versus a less-intensive 12-monthly control LSM (C-LSM) intervention on a primary composite endpoint of predictors of cardio-metabolic disease (new onset T2DM, hypertension, impaired glucose tolerance (IGT), impaired fasting glycaemia (IFG) and markers of cardio-renal disease) in participants aged 5-40 years with risk factors for T2DM.MethodsThis was a randomised controlled trial performed at the National Diabetes Centre, Sri-Lanka. We individually randomised 4672 participants at risk of T2DM, of whom 3539 (mean age 22.5 (range 6-40 years, 48% males) received either trimonthly (P-LSM n?=?1726) or 12-monthly (C-LSM n?=?1813) peer educator advice aimed at reducing weight, improving diet, reducing psychological stress and increasing physical activity.ResultsDuring a median follow-up of 3 years, the cumulative incidence of the primary endpoint was n?=?479 in P-LSM (74 per 1000 person years) vs. 561 in C-LSM (96 per 1000 person years), with an incident rate ratio (IRR) of 0.89 (95% CI 0.83-0.96, P?=?0.02). In post hoc analyses, new onset dysglycaemia (T2DM, IFG and IGT), was the major contributor to the composite and was significantly reduced by P-LSM (IRR 0.9, 95% CI 0.83-0.97, P?=?0.01). A significant impact of P-LSM on the incidence of the composite endpoint was noted in 1725 participants (P-LSM n?=?850, C-LSM n?=?875) aged below 18; P-LSM n?=?140 (48 per 1000 person years) versus C-LSM n?=?174 (55.4 per 1000 person years), with an IRR of 0.83 (95% CI 0.73-0.94, P?=?0.004).ConclusionsIn a young at-risk South-Asian population, a pragmatic LSM programme significantly reduces the incidence of predictors of cardio-metabolic disease. Our results highlight the importance of early intervention in young at-risk subjects.Trial registrationWorld Health Organization international clinical trial registry platform ( SLCTR/2008/003 ). Registration Date: March 28, 2008. Retrospectively registered.

Project description:BackgroundObesity is one of the conditions that increases the risk of cardiovascular disease. Studies about obesity trajectory and cardio metabolic outcomes at adulthood are still scarce. Therefore, we aimed to assess the association between patterns of overweight over the life-course and cardio metabolic risk factors in young adults.MethodsIn 1982, the maternity hospitals in Pelotas were visited daily and those newborns whose family lived in the urban area of the city were identified (n = 5914), and have prospectively followed for several occasions. Weight and height were measured at every visit. BMI-for-age z-score was calculated using the WHO Child Growth Standards. Overweight and obesity were defined as a BMI greater than or equal to 25 kg/m2 and 30 kg/m2 respectively. This was the definition adopted for evaluations overweight and obesity at 30 years. The participants were divided into eight groups according to the presence of overweight or obesity in childhood, adolescence and adulthood. Blood pressure, random blood glucose, HDL cholesterol, LDL cholesterol triglycerides and fat mass were measured.ResultsFrom 2219 participants with anthropometric data in childhood, adolescence and adulthood, 25% never had been overweight, whereas 11.6% were overweight in the three periods. Random blood glucose, SBP and DBP were higher among those subjects who were always overweight/ obese or only overweight/obese during adolescence and adulthood. The participants who were never overweight/obese or only in childhood or adolescence had a lower cardiovascular risk profile (higher HDL cholesterol, lower blood pressure, lower random glucose, lower LDL cholesterol) at 30 years. Fat mass captured from 25 to 100% of the association of overweight and obesity trajectory with cardiometabolic risk factors.ConclusionsThe tracking of overweight/obesity is associated with an adverse cardio metabolic profile and this association is largely mediated by fat mass in adulthood.

Project description:BackgroundWe have previously demonstrated in the DIABRISK-SL trial that a trimonthly pragmatic lifestyle modification (P-LSM), as compared to a 12-monthly LSM advice (C-LSM), significantly reduced the primary composite endpoint of predictors of cardio-metabolic disease (new onset type 2 diabetes (T2DM), hypertension, impaired glucose tolerance (IGT), impaired fasting glycaemia and markers of cardio-renal disease) in urban participants aged below 40?years with risk factors for T2DM.Main textWe now report results of post hoc analyses for those aged below 18 (n?=?1725) in three age groups, specifically of 6-10?years (P-LSM n?=?77, C-LSM n?=?59), 10-14?years (P-LSM n?=?534, C-LSM n?=?556) and 14-18?years (P-LSM n?=?239, C-LSM n?=?260). There was no effect of P-LSM on the primary endpoint in participants aged below 10?years. Participants aged 10-14?years in the P-LSM intervention as compared to C-LSM had a lower incidence of the primary combined endpoint (87 vs. 106 cases; incident rate ratio (IRR)?=?0.85, 95% confidence intervals (CI) 0.72-1.01; P?=?0.07), driven mainly by the lower incidence of new onset hypertension (24 vs. 37 cases; IRR?=?0.67, 95% CI 0.49-0.91; P?=?0.012). Participants aged 14-18?years in the P-LSM intervention had a lower incidence of the composite endpoint (36 vs. 54 cases; IRR?=?0.73, 95% CI 0.57-0.94; P?=?0.015) as well as a lower incidence of IGT (12 vs. 21 cases; IRR?=?0.6, 95% CI 0.39-0.92; P?=?0.02), new onset hypertension (6 vs. 15 cases; IRR?=?0.43, 95% CI 0.25-0.76; P?=?0.004), and new onset dysglycaemia (composite of new T2DM, IGT and impaired fasting glycaemia) (30 vs. 46 cases; IRR?=?0.74, 95% CI 0.56-0.97; P?=?0.03) compared to those assigned to the C-LSM intervention. Limitations of the analyses are the post hoc approach and the small number of events in each group. There were no differences in retention between the two groups.ConclusionsOur results suggest that, in young South Asians aged between 10 and 18?years at risk of T2DM, a pragmatic lifestyle modification programme may reduce the incidence of predictors of T2DM and hypertension. There is a need for further studies in younger populations to evaluate the impact and feasibility of interventions to reduce the burden of T2DM and associated cardio-metabolic risk. Please see related article: https://bmcmedicine.biomedcentral.com/articles/10.1186/s12916-017-0905-6.

Project description:BackgroundLatin America is facing an increasing burden of nutrition-related non-communicable disease. Little is known about dietary patterns in Guatemalan adults and how dietary patterns are associated with cardio-metabolic disease (CMD) risk.MethodsThis analysis is based on data from a 2002-04 follow-up study of the INCAP Nutrition Supplementation Trial Longitudinal Cohort. Diet data were collected using a validated, semi-quantitative food frequency questionnaire. We derived dietary patterns using principal components analysis. CMD risk was assessed by anthropometry (body mass index, waist circumference), biochemistry (fasting blood glucose and lipids), and clinical (blood pressure) measures. We used sex-stratified multivariable log binomial models to test associations between dietary pattern tertile and CMD risk factors. The sample included 1,428 participants (681 men and 747 women) ages 25-43 years.ResultsWe derived 3 dietary patterns (traditional, meat-based modern, and starch-based modern), collectively explaining 24.2% of variance in the diet. Dietary patterns were not associated with most CMD risk factors; however, higher starch-based modern tertiles were associated with increased prevalence of low high density lipoprotein cholesterol (HDL-c) in men (Prevalence Ratio (PR) 1.17, 95% Confidence Interval (CI) 1.01, 1.20 for tertile 2; PR 1.20, 95% CI 1.00, 1.44 for tertile 3; p trend 0.04). Higher traditional tertile was associated with increased prevalence of abdominal obesity in women (PR 1.24, 95% CI 1.07, 1.43 for tertile 2; PR 1.19, 95% CI 1.02, 1.39 for tertile 3; p trend 0.02) but marginally significant reduced prevalence of low HDL-c in men (PR 0.88, 95% CI 0.76, 1.00 for tertile 2; PR 0.85, 95% CI 0.72, 1.00 for tertile 3; p trend 0.05).ConclusionOur findings suggest the presence of two 'modern diet' patterns in Guatemala - one of which was associated with increased prevalence of low HDL-c in men. The association between the traditional dietary pattern and some CMD risk factors may vary by sex.

Project description:Background Metabolic syndrome (MetS) is associated with an increased incidence of chronic complications and mortality of diabetes patients. Prevention and treatment of MetS is important means of lowering the risk of cardiovascular diseases and mortality. Objective This study aimed to find out metabolic syndrome and life style factors among diabetes patients. Methods A cross-sectional survey was carried out among 296 patients with type 2 diabetes mellitus attending Chitwan Medical College Teaching Hospital. Consecutive sampling technique was used to select sample. Data were collected from 15th December 2021 to 15th March, 2022 using Interview Schedule, bio-physiological measurement and record review. Obtained data were analysed in SPSS version 20 for window using descriptive and inferential statistics. Chi-square test was applied to measure the association between the variables. Logistic regression analysis was performed to identify the factors associated with metabolic syndrome. Result Findings revealed that the prevalence of MetS was 66.2% and 58.4% in patients according to International Diabetes Federation (IDF) and National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) criteria respectively. The most common MetS parameters were raised fasting plasma glucose (94.6%) and abnormal waist circumference (78.4% in IDF criteria) while the least prevalent parameter was reduced HDL level (43.2%). Majorities of the patients were non-vegetarian (85.5%), had poor dietary compliance (poor-46.3%, very poor-32.1%), overweight/obese (65.5%), and suffered from moderate stress (90.1%). Bivariate analysis showed that MetS as per NCEP ATP criteria was significantly associated with gender (p = 0.006), occupation (p = 0.007), presence of other co-morbid condition (<0.001) and sleep problem (p = <0.001). However, MetS as per IDF criteria was significantly associated with age (p = <0.028), duration of diabetes (p = <0.001), follow-up visit (p = <0.030), blood sugar monitoring (p = <0.009) and physical activity of diabetes patients (p = <0.001). Further logistic regression analysis revealed that sleep problem (AOR = 21.812;95%CI = 8.512,55.894) and presence of other comorbidities (AOR = 4.024;95%CI = 2.220,7.295) were the significant factors of metabolic syndrome. Conclusion and recommendation Metabolic syndrome is high in patients with type 2 diabetes mellitus. Therefore, treating physicians and other health workers need to monitor MetS parameters regularly to reduce the risk of cardiovascular diseases, stroke and premature death.

Dataset Information

DIABRISK-SL prevention of cardio-metabolic disease with life style modification in young urban Sri Lankan's--study protocol for a randomized controlled trial.

Background

Methods/design

Discussion

Trial registration

Publications

DIABRISK-SL prevention of cardio-metabolic disease with life style modification in young urban Sri Lankan's--study protocol for a randomized controlled trial.

Similar Datasets

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