Metabolic non-communicable disease health report of India: the ICMR-INDIAB national cross-sectional study (ICMR-INDIAB-17).

BACKGROUND: Non-communicable disease (NCD) rates are rapidly increasing in India with wide regional variations. We aimed to quantify the prevalence of metabolic NCDs in India and analyse interstate and inter-regional variations. METHODS: The Indian Council of Medical Research-India Diabetes (ICMR-INDIAB) study, a cross-sectional population-based survey, assessed a representative sample of individuals aged 20 years and older drawn from urban and rural areas of 31 states, union territories, and the National Capital Territory of India. We conducted the survey in multiple phases with a stratified multistage sampling design, using three-level stratification based on geography, population size, and socioeconomic status of each state. Diabetes and prediabetes were diagnosed using the WHO criteria, hypertension using the Eighth Joint National Committee guidelines, obesity (generalised and abdominal) using the WHO Asia Pacific guidelines, and dyslipidaemia using the National Cholesterol Education Program-Adult Treatment Panel III guidelines. FINDINGS: A total of 113 043 individuals (79 506 from rural areas and 33 537 from urban areas) participated in the ICMR-INDIAB study between Oct 18, 2008 and Dec 17, 2020. The overall weighted prevalence of diabetes was 11·4% (95% CI 10·2-12·5; 10 151 of 107 119 individuals), prediabetes 15·3% (13·9-16·6; 15 496 of 107 119 individuals), hypertension 35·5% (33·8-37·3; 35 172 of 111 439 individuals), generalised obesity 28·6% (26·9-30·3; 29 861 of 110 368 individuals), abdominal obesity 39·5% (37·7-41·4; 40 121 of 108 665 individuals), and dyslipidaemia 81·2% (77·9-84·5; 14 895 of 18 492 of 25 647). All metabolic NCDs except prediabetes were more frequent in urban than rural areas. In many states with a lower human development index, the ratio of diabetes to prediabetes was less than 1. INTERPRETATION: The prevalence of diabetes and other metabolic NCDs in India is considerably higher than previously estimated. While the diabetes epidemic is stabilising in the more developed states of the country, it is still increasing in most other states. Thus, there are serious implications for the nation, warranting urgent state-specific policies and interventions to arrest the rapidly rising epidemic of metabolic NCDs in India. FUNDING: Indian Council of Medical Research and Department of Health Research, Ministry of Health and Family Welfare, Government of India.

Variations in glycated haemoglobin with age among individuals with normal glucose tolerance: Implications for diagnosis and treatment-Results from the ICMR-INDIAB population-based study (INDIAB-12).

AIM: To report on glycated haemoglobin (HbA1c) values among individuals with normal glucose tolerance (NGT) at different age groups, using data acquired from a large national survey in India. MATERIALS AND METHODS: Data on glycaemic parameters at different age groups were obtained from the Indian Council of Medical Research-INdia DIABetes (ICMR-INDIAB) study, in adults aged ≥ 20 years representing all parts of India. Age-wise distribution of HbA1c was assessed among individuals with NGT (n = 14,222) confirmed by an oral glucose tolerance test using the World Health Organization (WHO) criteria. Results were validated in another large epidemiological study (n = 1077) conducted in Chennai, India. RESULTS: Among NGT individuals, HbA1c increased gradually with age from 5.16 ± 0.71% (33 mmol/mol) in the age group of 20-29 years to 5.49 ± 0.69% (37 mmol/mol) in those aged 70 + years. In the validation study, conducted in another study population, HbA1c was 5.35 ± 0.43% (35 mmol/mol) in age group of 20-29 years and 5.74 ± 0.50% (39 mmol/mol) in those aged 70 and above. In the INDIAB study, for every decadal increase in age, there is a 0.08% increase in HbA1c and this increase was more significant in females (females: 0.10% vs. males: 0.06%) and in urban (urban: 0.10% vs. rural: 0.08%) population. CONCLUSIONS: HbA1c levels increase steadily with age. This suggests that age-specific cutoffs be used while utilizing HbA1c to diagnose diabetes and prediabetes, so as to minimize the risk of overdiagnosis and unnecessary initiation of treatment in elderly people who could have physiological increase in HbA1c levels.

Country-Specific Prevalence and Incidence of Youth-Onset Type 2 Diabetes: A Narrative Literature Review.

BACKGROUND: With increased awareness of type 2 diabetes (T2D) in children and adolescents, an overview of country-specific differences in epidemiology data is needed to develop a global picture of the disease development. SUMMARY: This study examined country-specific prevalence and incidence data of youth-onset T2D published between 2008 and 2019, and searched for national guidelines to expand the understanding of country-specific similarities and differences. Of the 1,190 articles and 17 congress abstracts identified, 58 were included in this review. Our search found the highest reported prevalence rates of youth-onset T2D in China (520 cases/100,000 people) and the USA (212 cases/100,000) and lowest in Denmark (0.6 cases/100,000) and Ireland (1.2 cases/100,000). However, the highest incidence rates were reported in Taiwan (63 cases/100,000) and the UK (33.2 cases/100,000), with the lowest in Fiji (0.43 cases/100,000) and Austria (0.6 cases/100,000). These differences in epidemiology data may be partly explained by variations in the diagnostic criteria used within studies, screening recommendations within national guidelines and race/ethnicity within countries. Key Messages: Our study suggests that published country-specific epidemiology data for youth-onset T2D are varied and scant, and often with reporting inconsistencies. Finding optimal diagnostic criteria and screening strategies for this disease should be of high interest to every country. TRIAL REGISTRATION: Not applicable.

Prevalence of diabetes and prediabetes in 15 states of India: results from the ICMR-INDIAB population-based cross-sectional study.

BACKGROUND: Previous studies have not adequately captured the heterogeneous nature of the diabetes epidemic in India. The aim of the ongoing national Indian Council of Medical Research-INdia DIABetes study is to estimate the national prevalence of diabetes and prediabetes in India by estimating the prevalence by state. METHODS: We used a stratified multistage design to obtain a community-based sample of 57 117 individuals aged 20 years or older. The sample population represented 14 of India's 28 states (eight from the mainland and six from the northeast of the country) and one union territory. States were sampled in a phased manner: phase I included Tamil Nadu, Chandigarh, Jharkhand, and Maharashtra, sampled between Nov 17, 2008, and April 16, 2010; phase II included Andhra Pradesh, Bihar, Gujarat, Karnataka, and Punjab, sampled between Sept 24, 2012, and July 26, 2013; and the northeastern phase included Assam, Mizoram, Arunachal Pradesh, Tripura, Manipur, and Meghalaya, with sampling done between Jan 5, 2012, and July 3, 2015. Capillary oral glucose tolerance tests were used to diagnose diabetes and prediabetes in accordance with WHO criteria. Our methods did not allow us to differentiate between type 1 and type 2 diabetes. The prevalence of diabetes in different states was assessed in relation to socioeconomic status (SES) of individuals and the per-capita gross domestic product (GDP) of each state. We used multiple logistic regression analysis to examine the association of various factors with the prevalence of diabetes and prediabetes. FINDINGS: The overall prevalence of diabetes in all 15 states of India was 7·3% (95% CI 7·0-7·5). The prevalence of diabetes varied from 4·3% in Bihar (95% CI 3·7-5·0) to 10·0% (8·7-11·2) in Punjab and was higher in urban areas (11·2%, 10·6-11·8) than in rural areas (5·2%, 4·9-5·4; p<0·0001) and higher in mainland states (8·3%, 7·9-8·7) than in the northeast (5·9%, 5·5-6·2; p<0·0001). Overall, 1862 (47·3%) of 3938 individuals identified as having diabetes had not been diagnosed previously. States with higher per-capita GDP seemed to have a higher prevalence of diabetes (eg, Chandigarh, which had the highest GDP of US$ 3433, had the highest prevalence of 13·6%, 12.8-15·2). In rural areas of all states, diabetes was more prevalent in individuals of higher SES. However, in urban areas of some of the more affluent states (Chandigarh, Maharashtra, and Tamil Nadu), diabetes prevalence was higher in people with lower SES. The overall prevalence of prediabetes in all 15 states was 10·3% (10·0-10·6). The prevalence of prediabetes varied from 6·0% (5·1-6·8) in Mizoram to 14·7% (13·6-15·9) in Tripura, and the prevalence of impaired fasting glucose was generally higher than the prevalence of impaired glucose tolerance. Age, male sex, obesity, hypertension, and family history of diabetes were independent risk factors for diabetes in both urban and rural areas. INTERPRETATION: There are large differences in diabetes prevalence between states in India. Our results show evidence of an epidemiological transition, with a higher prevalence of diabetes in low SES groups in the urban areas of the more economically developed states. The spread of diabetes to economically disadvantaged sections of society is a matter of great concern, warranting urgent preventive measures. FUNDING: Indian Council of Medical Research and Department of Health Research, Ministry of Health and Family Welfare, Government of India.

Review of Clinical Profile of IDegAsp.

In patients with diabetes, treatment intensification requires basal and bolus insulin injections to control the fasting and prandial insulin needs. To overcome the burden of multiple daily injections, co-formulating basal and bolus insulins in single injection could allow a simple regimen with fewer injections. Current premixed insulin analogues are limited by the protaminated insulin component, which cannot provide effective basal coverage. While, long-acting insulin analogues like insulin glargine and insulin detemir cannot be combined with rapid-acting insulin analogues due to physicochemical incompatibility. Insulin degludec/insulin aspart (IDegAsp) is a soluble co-formulation of two distinct insulin analogues in the ratio of 70% ultra-long-acting insulin degludec (IDeg) and 30% rapid-acting insulin aspart (IAsp). The distinct PK/PD properties of IDeg and IAsp components are preserved in the co-formulation, with the rapid absorption characteristics of IAsp and flat and stable profile of IDeg maintained separately. Size exclusion chromatography studies of IDegAsp indicate that IDeg and lAsp exist as stable di-hexamers and hexamers, respectively in the formulation. Moreover, at steady state, the prandial and basal glucose lowering effects of IDeg and IAsp were distinct and clearly separated. A clear dose-response relationship was observed in patients with type 1 and type 2 diabetes treated with IDegAsp. The glucose lowering effects of basal and prandial components of IDegAsp are maintained in elderly (≥ 65 years of age) patients with type 1 diabetes. In addition, the PK and clearance of IDeg and IAsp are not affected by mild, moderate or severe renal or hepatic impairment. Presence of two distinct insulin analogues, as a soluble co-formulation with basal component with an ultra-long duration of action makes IDegAsp an advance to premix insulins.

Prevalence of generalized & abdominal obesity in urban & rural India--the ICMR-INDIAB Study (Phase-I) [ICMR- NDIAB-3].

BACKGROUND & OBJECTIVES: Overweight and obesity are rapidly increasing in countries like India. This study was aimed at determining the prevalence of generalized, abdominal and combined obesity in urban and rural India. METHODS: Phase I of the ICMR-INDIAB study was conducted in a representative population of three States [Tamil Nadu (TN), Maharashtra (MH) and Jharkhand (JH)] and one Union Territory (UT)[Chandigarh (CH)] of India. A stratified multi-stage sampling design was adopted and individuals ≥ 20 yr of age were included. WHO Asia Pacific guidelines were used to define overweight [body mass index (BMI) ≥ 23 kg/m [2] but < 25 kg/m [2]], generalized obesity (GO, BMI ≥ 25 kg/m [2], abdominal obesity (AO, waist circumference ≥ 90 cm for men and ≥ 80 cm for women) and combined obesity (CO, GO plus AO). Of the 14,277 participants, 13,800 subjects (response rate, 96.7%) were included for the analysis (urban: n = 4,063; rural: n = 9737). RESULTS: The prevalence of GO was 24.6, 16.6, 11.8 and 31.3 per cent among residents of TN, MH, JH and CH, while the prevalence of AO was 26.6, 18.7, 16.9 and 36.1 per cent, respectively. CO was present in 19.3, 13.0, 9.8 and 26.6 per cent of the TN, MH, JH and CH population. The prevalence of GO, AO and CO were significantly higher among urban residents compared to rural residents in all the four regions studied. The prevalence of overweight was 15.2, 11.3, 7.8 and 15.9 per cent among residents of TN, MH, JH and CH, respectively. Multiple logistic regression analysis showed that female gender, hypertension, diabetes, higher socio-economic status, physical inactivity and urban residence were significantly associated with GO, AO and CO in all the four regions studied. Age was significantly associated with AO and CO, but not with GO. INTERPRETATION & CONCLUSIONS: Prevalence of AO as well as of GO were high in India. Extrapolated to the whole country, 135, 153 and 107 million individuals will have GO, AO and CO, respectively. However, these figures have been estimated from three States and one UT of India and the results may be viewed in this light.

Glycemic control among individuals with self-reported diabetes in India--the ICMR-INDIAB Study.

AIMS: This study estimated the levels of glycemic control among subjects with self-reported diabetes in urban and rural areas of four regions in India. RESEARCH DESIGN AND METHODS: Phase I of the Indian Council of Medical Research-India Diabetes (ICMR-INDIAB) Study was conducted in a representative population of three states of India (Tamil Nadu, Maharashtra, and Jharkhand) and one Union Territory (Chandigarh) and covering a population of 213 million people. Using a stratified multistage sampling design, individuals ≥20 years of age were recruited. Glycemic control among subjects with self-reported diabetes was assessed by measurement of glycated hemoglobin (HbA1c), estimated by the Variant™ II Turbo method (Bio-Rad, Hercules, CA). RESULTS: Among the 14,277 participants in Phase I of INDIAB, there were 480 subjects with self-reported diabetes (254 urban and 226 rural). The mean HbA1c levels were highest in Chandigarh (9.1±2.3%), followed by Tamil Nadu (8.2±2.0%), Jharkhand (8.2±2.4%), and Maharashtra (8.0±2.1%). Good glycemic control (HbA1c <7%) was observed only in 31.1% of urban and 30.8% of rural subjects. Only 22.4% of urban and 15.4% of rural subjects had reported having checked their HbA1c in the past year. Multiple logistic regression analysis revealed younger age, duration of diabetes, insulin use, and high triglyceride levels to be significantly associated with poor glycemic control. CONCLUSIONS: The level of glycemic control among subjects with self-reported diabetes in India is poor. Urgent action is needed to remedy the situation.

Prevalence of dyslipidemia in urban and rural India: the ICMR-INDIAB study.

AIM: To study the pattern and prevalence of dyslipidemia in a large representative sample of four selected regions in India. METHODS: Phase I of the Indian Council of Medical Research-India Diabetes (ICMR-INDIAB) study was conducted in a representative population of three states of India [Tamil Nadu, Maharashtra and Jharkhand] and one Union Territory [Chandigarh], and covered a population of 213 million people using stratified multistage sampling design to recruit individuals ≥20 years of age. All the study subjects (n = 16,607) underwent anthropometric measurements and oral glucose tolerance tests were done using capillary blood (except in self-reported diabetes). In addition, in every 5th subject (n = 2042), a fasting venous sample was collected and assayed for lipids. Dyslipidemia was diagnosed using National Cholesterol Education Programme (NCEP) guidelines. RESULTS: Of the subjects studied, 13.9% had hypercholesterolemia, 29.5% had hypertriglyceridemia, 72.3% had low HDL-C, 11.8% had high LDL-C levels and 79% had abnormalities in one of the lipid parameters. Regional disparity exists with the highest rates of hypercholesterolemia observed in Tamilnadu (18.3%), highest rates of hypertriglyceridemia in Chandigarh (38.6%), highest rates of low HDL-C in Jharkhand (76.8%) and highest rates of high LDL-C in Tamilnadu (15.8%). Except for low HDL-C and in the state of Maharashtra, in all other states, urban residents had the highest prevalence of lipid abnormalities compared to rural residents. Low HDL-C was the most common lipid abnormality (72.3%) in all the four regions studied; in 44.9% of subjects, it was present as an isolated abnormality. Common significant risk factors for dyslipidemia included obesity, diabetes, and dysglycemia. CONCLUSION: The prevalence of dyslipidemia is very high in India, which calls for urgent lifestyle intervention strategies to prevent and manage this important cardiovascular risk factor.

The Indian Council of Medical Research-India Diabetes (ICMR-INDIAB) study: methodological details.

BACKGROUND: Currently available estimates of diabetes prevalence in India are based on published data derived from very few studies. The Indian Council of Medical Research-India Diabetes (ICMR-INDIAB) study is a community-based survey conceived with the aim of obtaining the prevalence rates of diabetes in India as a whole, covering all 28 states, the National Capital Territory of Delhi, and two of the union territories in the mainland of India, with a total sample size of 124,000 individuals. METHODS: A stratified multistage sampling design has been used. In all study subjects, a structured questionnaire was administered and anthropometric parameters and blood pressure were measured. Fasting capillary blood glucose was first determined using a glucose meter. An oral glucose load was then administered to all subjects except those with self-reported diabetes, and the 2 h post-load capillary blood glucose was estimated. In every fifth subject, a fasting venous sample was collected for measurement of lipids and creatinine, a resting 12-lead electrocardiogram was performed, and dietary assessment questionnaire was administered. In all diabetic subjects, an additional diabetes questionnaire was used and a fasting venous sample drawn for glycated hemoglobin. RESULTS: All biological samples collected were analyzed in a central laboratory. All data collected were stored electronically. Quality control was achieved through multiple tiers of checks. CONCLUSIONS: The ICMR-INDIAB study is the first of its kind attempting to provide accurate and comprehensive state- and national-level data on diabetes prevalence in India.