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Research Article
Babu et al. EUROPEAN JOURNAL OF PHARMACEUTICAL
European Journal of Pharmaceutical and Medical Research
AND MEDICAL RESEARCH ISSN 2394-3211
www.ejpmr.com EJPMR

AN ASSOCIATIVE STUDY OF NON-LIPID RISK FACTORS (HIGH SENSITIVE-CRP,

URIC ACID AND THYROID STIMULATING HORMONE) WITH PARAMETERS OF
TYPE 2 DIABETES MELLITUS, BLOOD PRESSURE IN METABOLIC SYNDROME

V. Srinivasa Babu1*, V. Kalyan Chakravarthy2, C. Ramaswamy3, S. Srikanth4, M. Karthik5

1
Department of Research, Saveetha University, Thandalam, Chennai, Tamilnadu, India.
2
Professor, Department of Pathology, Pinnamaneni Institute of Medical Sciences and Research Foundation,
Chinnautapalli, Gannavaram, Andhra Pradesh, India.
3
Professor, Department of Physiology, Saveetha Medical College, Thandalam, Chennai, Tamilnadu, India.
4
Assistant Professor, Department of Community medicine, Nimra Institute of Medical Sciences, Ibrahimpatnam,
Vijayawada, Andhra Pradesh, India.521456.
5
Assistant Professor, Department of Physiology, Nimra Institute of Medical Sciences, Ibrahimpatnam, Vijayawada,
Andhra Pradesh, India. 521456.

*Corresponding Author: Dr. V. Srinivasa Babu

Department of Research, Saveetha University, Thandalam, Chennai, Tamilnadu, India.

Article Received on 27/12/2018 Article Revised on 16/01/2019 Article Accepted on 05/02/2019

ABSTRACT
Background: Metabolic syndrome is the huddle of diseases for atherosclerotic cardiovascular disease (ASCVD)
which arises due to excess of plasma glucose, cholesterol, fatty acids, blood pressure and obesity. The role of lipids
in the development of MetS had been extensively studied. Some non-lipid factors like hsCRP, uric acid and TSH
level also remain elevated in the serum of the MetS patients the correlation of the same with the MetS not fully
determined. Aim and Objectives: Hence in this study our aim and objectives was to assess the significance of non-
lipid risk factors in determining the severity of MetS with the association of type 2 diabetes and blood pressure
parameters. Methods: A total of 450 subjects (211 men and 239 women) aged ≥ 35 years attending the hospital
were divided based on the components of MetS as control (CS), Metabolic syndrome (MS) and severe (SMS) MetS
groups. Comparative study was done by one way ANOVA and variables with significant associations were
included in regression analysis to determine the future prediction with non-lipid risk factors hs-CRP, serum uric
acid and TSH as dependent variables. The cardiovascular and T2DM related parameters FPG, HbA1c, serum
fasting insulin, HOMA-IR, SBP, DBP, PR were independent variables in this study. Results: All the T2DM and
BP variables had highly significant relation (P<0.001) when compared MetS and severe Mets group with control
group. In this study, the value of participants HbA1C, PR, FPG, DBP and IR had significant Adjusted OR [3.03
P<0.001; 2.10 P 0.004; 1.86 P 0.033; 0.17, P <0.001 and 0.08, P <0.001 respectively] high positive correlation with
the hs-CRP values. It was found that HbA1c, SBP, DBP, FPG and PR had significant predictive AOR [5.829
P<0.001; 2.789 P 0.007; 0.098 P<0.001; 0.383 P 0.008 and 0.543 P 0.053 respectively] in association with Uric
acid values. Also, PR, FPG and DBP had significant AOR significance [1.96 P 0.001; 1.41 P <0.001; 1.37 P 0.026
respectively] in association with TSH values. Conclusion: It can be concluded that reducing the above T2DM and
cardiovascular variables by various lifestyles or other means can reduce the levels of non-lipid risk factors and
thereby arrest susceptibility of the development of MetS and severe MetS.

KEYWORDS: T2DM; HTN; Metabolic syndrome; Non-lipid risks; hs-CRP; Uric acid; TSH.

INTRODUCTION sign for high incidence of MetS in other South Asian

Metabolic syndrome is the huddle of diseases for countries and India.[3-5]
atherosclerotic cardiovascular disease (ASCVD) which
arises due to excess of plasma glucose, cholesterol, fatty An environmental, metabolic and genetic aspects,
acids, blood pressure and obesity.[1,2] Around the world it evidently signifies a multidimensional interface of
is appraised that one out of four people suffers from etiology of this syndrome but it is mostly unspecified.[6,7]
MetS in spite of the competing on its definition.[2] For myocardial infarction (MI), cerebrovascular accident
Individual constellation of epidemic risk factors of the (CVA) and incidence of type 2 diabetes mellitus (T2 DM)
pervasiveness of Mets, is intensifying with different are allied and amplified risk by frequent manifestations
regions of all over the world, and specifically there is a of prothrombotic and proinflammatory condition of the
subjects with these characteristics.[8-10]

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Although in previous cross-sectional studies elevated is defined according to the 2009 harmonizing definition
high sensitivity C-reactive protein (hs-CRP) levels had set by a joint statement of the International Diabetes
significant association with individual modules of MetS Federation Task Force on Epidemiology and Prevention;
like adiposity, hyperinsulinemia, insulin resistance, National Heart, Lung, and Blood Institute; American
hypertriglyceridemia, and low HDL cholesterol[11,12], but Heart Association; Word Heart Federation; International
not in relation to severity of MetS. MetS and Thyroid Atherosclerosis Society; and International Association
Disorders (TD) comparison and association is complex for the Study of Obesity, as the presence of three or more
and uncertain.[13] Studies showed a significant of the following five criteria.[25]
relationship of SCH (subclinical hypothyroidism) with 1) Waist circumference in South Asians >90 cm in men
components of MetS.[14,15] Shantha et al. study[16], and >80 cm in women.
showed the association of primary hypothyroidism in the 2) Serum triglycerides levels >150 mg/dl.
urban population with MetS. So, the design of TD in 3) Serum HDL cholesterol levels < 40 mg/dl in men and
MetS and its components differs in unlike studies. There < 50 mg/dl in women, under treatment is an alternate
is a evidence that many studies have concentrated on the indicator.
serum uric acid (SUA), MetS, and carotid atherosclerosis 4) Systolic blood pressure >130 mmHg and/or diastolic
relationship.[17-20] The atherosclerotic vascular disease blood pressure >85 mmHg) under treatment is an
and SUA is leftovers contradictory.[21] Some studies alternate indicator, and.
experiential that relationship between SUA and 5) Fasting serum glucose levels >100 mg/dL under
atherosclerotic vascular disease is assign to an indirect treatment.[26]
association of increased levels of SUA with
cardiovascular risk factors or constellation of these The same standard is also stated in the modified NECP
metabolic and hemodynamic risk factors, projected ATP III definition.[27]
MetS.[22,23]
The inclusion criteria for patients: Insulin resistance,
The elevated levels of the inflammatory markers like hs- hypertension, type II diabetes mellitus, increased BMI, is
CRP and serum uric acid levels are associated with ≥ 23, Increased waist circumference ≥ 36 inches (90cm)
increased risk for development of cardiovascular disease in males and ≥32 inches (80cm) in females and age limit
and diabetes mellitus. Adding hs-CRP values in the is ≥35. Exclusion criteria: Any recent infections, Active
diagnostic criteria for metabolic syndrome has shown to lifestyle, PCOD in women and fatty liver disease.
improve future prediction of development of these
diseases.[24] In present study, one step forward we tried to Baseline parameters
see the association between non lipid risk factors of •Blood pressure and anthropometric data including
MetS like hs-CRP, Uric acid and TSH and the Type 2 height, weight, waist circumference were measured using
DM, BP parameters in relation to severity of Metabolic standard techniques.
syndrome. •Blood Pressure was measured using a Mercury
Sphygmomanometer (Diamond, Mumbai, India) with the
Here is a significant evidence that type 2 diabetes and patients in a sitting position, legs uncrossed. After 5
cardiovascular parameters influences non-lipid risks in minutes of rest in the sitting position, BP was measured
MetS and severe MetS and by reducing levels of these on both arms and the higher of the two is taken into
factors by life style changes thus decrease susceptibility consideration. If the systolic and diastolic blood pressure
of MetS. Further, helps to decrease morbidity micro and were in different categories, the higher of the two was
macro vascular diseases of vital organs like brain, heart, used in the classification and on that visit; fasting blood
and kidneys and the metabolic diseases HTN and Type 2 samples was drawn from the subjects.
Diabetes Mellitus. •Biochemical analysis: Fasting blood samples were
obtained from the subjects and centrifuged at 2000×g for
AIM AND OBJECTIVES 10 min. Samples were analyzed for MetS component of
Our aim is to study of significance of non-lipid risk fasting plasma glucose, uric acid using by ERBA EM-
factors (hs-CRP, Uric acid and TSH) in severity of MetS 360 fully automated analyzer. Also MetS non-lipid risk
and the association of type 2 diabetes and blood pressure factors such as serum TSH, high sensitive C-reactive
parameters. protein (hs-CRP) and serum fasting Insulin were
assessed by Enzyme Linked Immuno Sorbent Assay
MATERIALS AND METHODS (ELISA) method. HbA1c is assessed by High
A total of 450 participants (211 men and 239 women) performance liquid chromatography (HPLC), and
aged ≥35 years attending our institute hospital from 2nd Homeostatic model for assessment of Insulin Resistance
December, 2015 to 4th August, 2017 were included in (IR) was calculated (HOMA- IR (µmol/L) = FI mIU/L X
this study. The study protocol was approved by the FPG (mmol/L) / 22.5 and conversion of FPG mg/dl to
Institutional Ethics Committee. All the participating mmol/L divided by 18 if mmol/L to mg/dl is multiply by
subjects in the study gave written informed consent. 18 and pulse rate is assessed by pulse meter.
Criteria for choosing the subjects: As per the guidelines
issued by the following international organizations: MetS

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Further the groups were divided into three groups (150 parameters FPG, HbA1c, serum fasting Insulin, HOMA-
participants in each group), according to the number of IR, SBP, DBP, PR are independent variables for all the
components of Metabolic syndrome risk factors participants used to investigate future predictive study of
mentioned above they acquired. our three non-lipid risks. Statistical significance was
considered if the P value is less than 0.05.
Group I: Subjects with less than any of the three
components of metabolic syndrome (Control group), RESULTS
Group II: Subjects with any three components of Analysis of the Results
metabolic syndrome (MS group), The results of the different parameters in there groups of
Group III: Subjects with more than three components of MS were represented in Figure.1 In this Type 2 Diabetes
metabolic syndrome (Severe MS group {SMS}) mellitus in the severity of MetS were compared between
the controls and MS and SMS and the statistical analysis
Statistical analysis: Data were entered on Excel and showed that the values of Insulin resistance [HOMA-IR]
imported for analysis on SPSS v 16. were significantly higher among MS (3.3±0.2) and SMS
(5.3±0.2) groups when compared to controls (1.9±0.1).
To find out the descriptive study of mean and standard The values of the following in control, MS and SMS
error was done by one way ANOVA analysis. MetS were respectively: mean fasting plasma glucose (6.8±0.2,
variables FPG, HOMA-IR, Hb A1c %, S F Insulin,, SBP, 8.9±0.3 and 4.5±0.1), glycosylated hemoglobin (6.4±0.1,
DBP, PR, hs-CRP and Uric acid were highly significant 7.4±0.1 and 5.9±0.1) and serum fasting insulin (9.6±0.5,
(P <0.001) and TSH was not significant. Regression 13.1±0.6 and 8.9±0.3) and the statistical analysis of these
analysis (Multiple) was done with non-lipid risk factors values showed that it was significantly higher (P <0.001)
hs-CRP, serum uric acid and TSH individually taken as in MS and SMS groups when compared with Controls
dependent variables. The cardiovascular and biochemical (8.9±0.3).

Figure.1: Comparison of mean and SE of Fasting plasma glucose (FPG), HOMA index of insulin resistance
(HOMA-IR), Glycosylated hemoglobin (HbA1c) and Serum fasting insulin (SFI).

Group I: Control (146.7±1.3) groups when compared to controls

Group II: MS group and (122.5±1.0). This was statistically highly significant
Group III: Severe MS P<0.001. Same as diastolic blood pressure (82.9±0.7,
86.5±0.8 and 78.1±0.6), Mean pulse rate (78.3±0.7,
Likewise, the values of the Blood pressure parameters of 79.1±0.9 and 74.4±0.7) was significantly higher in MS
the participants were given in Figure.2 and result showed and SMS groups when compared with Controls and all
that the systolic blood pressure mean and SE had these blood pressure parameters also statistically highly
significantly higher among MS (137.9±1.3) and SMS significant P<0.001.

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Babu et al. European Journal of Pharmaceutical and Medical Research

Figure 2: Comparison of mean and SE of Systolic blood pressure (SBP-mmHg), Diastolic blood pressure (DBP-
mmHg) and Pulse rate (PR -min).

Group I: Control control group (1.5 ± 0.1) and Uric acid MS (5.0 ± 0.1)
Group II: MS group and SMS (5.2 ± 0.1) Controls (4.6 ± 0.1) were highly
Group III: Severe MS significant but only the values of TSH showed [MS (3.2
± 0.2) SMS (3.0 ± 0.2) and controls (2.6 ± 0.1)] not
Figure.3 shows non-lipid risk factors hs-CRP mean and significant P 0.66 among themselves.
SE of MS group (2.2 ± 0.2), SMS group (2.1 ± 0.1) and

Figure 3: Comparison of mean and SE of Non-lipid risk factors high sensitive C-reactive protein (hs-CRP-mg/L),
serum Uric acid (SUA-mg/dl) and TSH (mIU/L) in controls, MS and SMS group.

Group I: Control coefficient of change in hs-CRP. The results are

Group II: MS group and represented in Table 1 and it was found that independent
Group III: Severe MS variables of IR Adjusted Odds Ratio (AOR 0.08, P
<0.001) and DBP (0.17, P <0.001) were independently
The results of the association of the non-lipid risk factors correlated with dependent variable hs-CRP; HbA1C, PR
with the components of MetS were represented in Table. and FPG which showed positive correlation of AOR 3.03
1, 2 and 3. All the above variables were recorded during P<0.001, 2.10 P 0.004, 1.86 P 0.033 respectively. Here,
the study period and were tabulated to find the HbA1C having highest predictor with the
association with a change in Hs-CRP. The factors with proinflammatory marker hs-CRP values among the study
significant associations were then included in a subjects.
regression analysis to determine the regression

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Table 1: Non-lipid risk factor Hs-CRP regression DISCUSSION

analysis with the variables IR, DBP, FPG, PR and MS is associated with an increased risk of diabetes, and a
HbA1C in Metabolic syndrome. number of cardiovascular events, such as myocardial
Variables Hs-CRP Adjusted OR P-value infarction, stroke, and heart failure28. The cost of
IR (µmol/L) 0.08 <0.001 treatment for metabolic diseases is infinite. In present
DBP (mmHg) 0.17 study we found significant association of many risk
<0.001
factors among MetS cases and controls could help to
FPG (mg/dL) 1.86 0.033 prevent the progression of MetS.
PR (min) 2.10 0.004
HbA1c % 3.03 <0.001 The severity of MetS increases proportionate to DM
related factors like FPG, HOMA-IR, S F Insulin and
Adjusted to HOMA-IR, DBP, FPG, PR and HbA1c HbA1c and also blood pressure parameters like SBP,
Unadjusted to SBP, Serum fasting Insulin DBP and PR. Regitz-Zagrosek V et al showed SBP and
Bold letters indicates high significance DBP are the predictors of MetS.[29] The findings of
Patrick H Dessein et al recognize the association of CRP
It was found that independent variables adjusted to DBP as an proinflammatory marker with CVD in Rheumatoid
(AOR 0.098 P<0.001), FPG (0.383 P 0.008) and PR arthritis and patients with increased waist circumference,
(0.543 P 0.053) had significant relation with dependent was significant regression analysis for the independent
variable Uric acid; while independent variables HbA1c, variable of HOMA-IR and hs-CRP.[30] In present study
and SBP with respective positive association AOR of we found that HOMA-IR, DBP, FPG, PR and HbA1c
5.829 P<0.001, 2.789 P 0.007. Thus the study showed were significantly associated with hs-CRP levels in MetS
that the metabolic end product Uric acid level in the cases. Some study by Devraj et al it was suggested that
blood had highest future predictor relation with HbA1c the patients at high risk for future prediction of Type 2
and to certain extent SBP. DM and CVD can be identified better by the addition of
hs-CRP to the present definition of the MetS may help
Table 2: Non-lipid risk factor Uric acid regression identify at high risk for future prediction of Type 2 DM
analysis with the following variables DBP, FPG, PR, and CVD.[28]
SBP and HbA1c in Metabolic syndrome.
Variables Uric acid Adjusted OR P-value Association between serum uric acid levels and the
DBP(mm/Hg) 0.098 <0.001 components of MetS showed that as independent
FPG (mg/dL) 0.383 0.008 variables DBP, FPG PR, SBP, and HbA1c had
PR (min) 0.543 0.053 significant predictors with dependent variable Uric acid.
SBP (mmHg) 2.789 0.007 Also, when compared to patients with normal serum uric
HbA1c % 5.829 <0.001 acid level it was predicted that hyperuricemic patients
have higher risks of having hypertension, hyperglycemia
and low HDL cholesterol. A number of previous studies
Adjusted to DBP, FPG, PR,SBP and HbA1c
also had reported such findings[31] Hyperuricemia
Unadjusted to IR, and Serum fasting Insulin
predicts the development of hypertension, obesity, and
Bold letter s indicates high significance
type 2 diabetes mellitus.[32] A strong correlation between
serum uric acid and MetS components showed in studies
The table 3 showed that PR, FPG and DBP had all
by Nejatinamini et al. and Lee et al.[33,34] Same predictor
significant positive adjusted odds (AOR 1.96 P 0.001,
results were found in correlative study of FBG and DBP
1.41 P <0.001, 1.37 P 0.026) respectively with increasing
shows positive correlation with salivary uric acid.[35]
the endocrinal hormone TSH values among the study
subjects. Here also TSH is a dependent variable and all
Thyroid dysfunction is well known cause abnormal
others are independent variables. In this, PR was the
glucose level and lipid profile; which in turn are
highest predictor next to it FPG.
important factors of metabolic syndrome.[36] In our study,
it was found that PR, FPG and DBP all had significant
Table 3: Non-lipid risk factor TSH regression
increase with increase in the hormone (TSH) values
analysis with the following variables DBP, FPG and
among the study subjects. Similar results were found in a
PR in Metabolic syndrome.
study by Jang J et al.[37] In the present study, non-lipid
Variables TSH Adjusted OR P-value
risk factors of MetS like hs-CRP and SUA levels were
DBP (mmHg) 1.37 0.026 significantly more in cases when compared to controls,
FPG (mg/dL) 1.41 <0.001 but no significant association was noted with TSH levels.
PR (min) 1.96 0.001 In contrast to our study, Zhou YC et al concluded that
TSH levels had a strong association with incident
Adjusted to DBP, FPG and PR MetS.[38]
Unadjusted to HOMA-IR, Serum fasting Insulin and
HbA1c and SBP.
Bold letters indicates significance.

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CONCLUSION escalation & possible solutions. Indian J Med Res,

It can be concluded that reducing the independent 2007; 125: 345-54.
variables like IR, DBP, FPG, PR and HbA1C with the 6. Groop L: Genetics of the metabolic syndrome. Br J
non-lipid inflammatory marker hs-CRP, variables like nutr, 2000; 83(suppl 1): S39-S48.
DBP, FPG, PR, SBP and HbA1C with the dependent 7. Lidfeldt J, Nyberg P, Nerbrand C, Samsioe G,
non-lipid metabolic end product serum uric acid values Scherstén B, Agardh CD: Sociodemographic and
and independent factors like DBP, FPG and PR with the psychological factors are associated with features of
endocrinal factor TSH values by various lifestyle or the metabolic syndrome: the Women’s Health in the
other means can help to reduce and there by the Lund Area (WHILA) study. Diabetes Obes Metab,
development of MetS. 2003; 5: 106-112.
8. Pradhan AD, Manson JE, Rifai N, Buring JE, Ridker
Thus reducing all these three non-lipid risk factors values PM: C-reactive protein, interleukin 6, and the risk of
reduces the susceptibility of MetS, thus the prevention developing type 2 diabetes mellitus. JAMA, 2001;
(the development) of MetS and severe MetS. 286: 327-334.
9. Freeman DJ, Norrie J, Caslake MJ, Gaw A, Ford I,
Future studies would include the association study of Lowe GD, O’Reilly DS, Packard CJ, Sattar N: C-
other non-lipid factors such as T3, T4 levels, urine reactive protein is an independent predictor of risk
microalbumin levels, serum creatinine and albumin- for the development of diabetes in the West of
creatine ratio with parameters of Type 2 DM and BP in Scotland Coronary Prevention Study. Diabetes, 2002;
Mets. 51: 1596-1600.
10. Ridker PM, Cushman M, Stampfer MJ, Tracy RP,
ACKNOWLEDGEMENTS Hennekens CH: Inflammation, aspirin, and the risk
The author would like to thank the faculty members of of cardiovascular disease in apparently healthy men.
Department of Research, Saveetha University, Chennai, N Engl J Med, 1997; 336: 973-979.
India and the Department of Physiology, Nimra Institute 11. Mendall MA, Patel P, Ballam L, Strachan D,
of Medical Sciences, Vijayawada, Andhra Pradesh, India Northfield TC: C-reactive protein and its relation to
(working as Assistant Professor) for their valuable advice, cardiovascular risk factors: a population based cross
guidance and constructive criticism. I also acknowledge sectional study. BMJ, 1996; 312: 1061-1065.
the subjects for their consent and participation in this 12. Yudkin JS, Stehouwer CD, Emeis JJ, Coppack SW:
study. C-reactive protein in healthy subjects: associations
with obesity, insulin resistance, and endothelial
Funding: No funding sources. dysfunction: a potential role for cytokines
Conflict of interest: None declared. originating from adipose tissue? Arterioscler
Thromb Vasc Bio, 1999; 19: 972-978.
Ethical approval: The study was approved by the 13. Gyawali P, Takanche JS, Shrestha RK, Bhattarai P,
Institutional Ethics Committee of Saveetha University, Khanal K, Risal P, Koju R. Pattern of thyroid
Chennai, India. dysfunction in patients with metabolic syndrome and
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