Características de la población pertenecientes a los quintiles I y II

2.2 El bono de desarrollo humano

2.2.4 Características de la población pertenecientes a los quintiles I y II

2. Apparently healthy subjects with no history of DM aged 30-65years.

3.7 EXCLUSION CRITERIA FOR THE CONTROLS 1. Unwillingness to participate in the study.

2. Acute febrile illness.

3.8 SAMPLE SIZE: It was determined using the sample size equation for a study comparing two proportions as stated below⁹⁵:

Where n’ = n1 (cases) = n2 (control) n’ = 2z²pq

d²

z= standard normal deviate= 1.96 (at 95% confidence level)

p=prevalence of metabolic syndrome in patients with type 2 diabetes mellitus in Nigeria = 63.6%⁸⁷

q= 1 – p

d=observed difference of 0.10 or more, significance at 0.05 level

n’= 2 x 1.96² x 0.636 x (1-0.636) 0.1²

n’= 177.87

Given the attrition rate of 10% the sample size was 194.87 which was then rounded up to 200 for the diabetic arm and 200 for the control arm. However, the researcher recruited 200 patients with type 2 diabetes mellitus and 100 subjects as controls.

3.9 MATERIALS: EQUIPMENT AND SUPPLIES

3.9.1 EQUIPMENT: The equipment that were used for the study include

 Mercury Sphygmomanometer (Accoson brand, England)

 Littmann Stethoscope (Littman Quality TM, USA)

 SECA weighing scale, England

 SECA stadiometer, England

 Flexible non-stretch measuring tape

 Accu-check active Glucometer and test strips (Roche diagnostics, Germany).

 Combi 10 urine test strips for Urinalysis

 Micral Urine test strips for microalbumin detection

 Spectrophotometer 2100

3.9.2 SUPPLIES AND REAGENTS: The required reagents and supplies include the following

 Randox Lipid profile test kits, serum Creatinine test kits and glucose estimation test kits,

 Bio-Rad in2it glycated haemoglobin cartridges were not used as stated in the proposal as this was no longer available at the time of the research and so reagent from teco diagnostics was used for laboratory analysis of glycated haemoglobin using spectrophotometer.

 General laboratory equipment like test tubes, pipettes, sample trays, plain specimen bottles, Lithium heparin specimen bottles, ethylenediamine tetraacetic acid (EDTA) specimen bottles, 5ml and 10ml syringe with 21G needles.

3.10 SAMPLING METHOD: This was by non-probability method. All consenting subjects who met the inclusion criteria for each of the groups were recruited consecutively from the Endocrinology MOPC and GOPD of Federal Teaching Hospital Ido-Ekiti until the sample size was reached.

Subjects in the control arm were recruited by disseminating information at the GOPD and among members of staff of the hospital. Individuals that showed interest were then screened to determine if they met the inclusion criteria. Those that met the inclusion criteria were matched for age and sex with those in the study group.

3.11 STUDY PROCEDURE 3.11.1 ETHICAL CLEARANCE

Ethical approval was obtained from the Ethics and Research Committee of the Federal Teaching Hospital Ido-Ekiti (Appendix B) after which written informed consent (Appendix C) was obtained from the patients and controls following due counseling and consideration.

3.11.2 SUBJECT RECRUITMENT

A pre-tested standard questionnaire drafted in the English language (Appendix A) was administered by the interviewer to consenting patients during clinic visits to obtain relevant

information. This included the patient’s age, sex, and duration of diabetes, as well as history of hypertension, smoking and alcohol history. Physical examination was performed on each subject to exclude those with physical findings in keeping with the exclusion criteria. Body weight, height (which were used to determine body mass index (BMI), waist circumference, hip circumference (HC), (used to determine waist to hip ratio (WHR) and blood pressure were measured in all study subjects and recorded.

All those who met the inclusion criteria (for both arms) were given a date and instructed/counseled on the procedure. On the day of the test, laboratory assessment for all subjects included the collection of 10-15mls of venous blood sample at once under aseptic procedure from the cubital fossa of the left or right arm of each subject between 8.00 to 10.00 a.m after an overnight fast of at least 8hours but not more than 12hours. These samples were then divided into aliquots of 2-4mls in each of the following specimen bottles; fluoride oxalate, EDTA and lithium heparin bottle respectively and kept in aliquots till ready for analysis. The samples in the fluoride oxalate bottles were used for analysis of plasma glucose, those samples in the EDTA bottles were used for glycated haemoglobin levels (HBA1c) while the samples in the lithium heparin bottles were used for analysis of lipid panel and serum creatinine. Subjects with diabetes mellitus had samples taken for 2-hour postprandial glucose estimation 2 hours after intake of their conventional home meal.

The samples were transported on ice-packs within 2-6 hours to the chemical pathology laboratory of the hospital where they were analyzed. Samples for plasma glucose, lipid profile and serum creatinine estimation were spun using a centrifuge to separate the plasma, this plasma was stored at -4^oc till analysis while whole blood was used for estimation of glycated haemoglobin. Plasma glucose (FPG/2hPP) and glycated haemoglobin samples were analyzed on

the same day while that of lipid profile and creatinine were stored and analyzed in batches of 50 every 2-4weeks.

Mid-stream urine sample was collected in universal bottles and these were used for dipstick urinalysis. Microalbumin estimation was done in subjects who had no proteinuria on the dipstick.

Only patients with diabetes mellitus had glycated haemoglobin check in order to determine their level of glycaemic control which helped to further subdivide them into controlled and uncontrolled subgroups.

The overall laboratory assay processes were handled by a Chemical Pathologist in conjunction with the primary researcher who observed all the processes and in addition centrifuged the blood samples to obtain serum/plasma and pipetted the samples. The primary researcher was also involved in the calculation of the values from the absorbance measured from the spectrophotometer.

3.12 MEASUREMENT OF CLINICAL AND ANTHROPOMETRIC PARAMETERS 3.12.1 ANTHROPOMETRIC MEASUREMENTS

Height, weight, waist and hip circumference and body mass index were determined for each participant.

3.12.2 WAIST AND HIP CIRCUMFERENCE

The waist circumference was taken at the approximate midpoint between the lower margin of the last palpable rib and the top of the iliac crest on the bare skin at the end of normal expiration, while the hip circumference was taken at the intertrochanteric level i.e at the widest portion of the buttocks. An inelastic tape was used and both measurements were taken with the subjects erect and the tape held snugly, but not constricting, at a level parallel to the floor.^{96, 97}

Abdominal obesity was defined as waist circumference of ≥ 102 cm in men and ≥ 88 cm in women.⁴⁸ Waist Hip Ratio (WHR) > 0.85 for females and > 0.90 for males were considered abnormal.⁹⁸

3.12.3 BODY MASS INDEX

Body Mass Index (BMI) is a simple index of weight-for-height that is commonly used to classify underweight, overweight and obesity in adults. It is defined as the weight in kilograms divided by the square of the height in meters (kg/m²).

The height was measured without shoes or headgear, with the subject standing erect on the floor board of the stadiometer with his or her back to the vertical backboard of the stadiometer. The heels of the feet were placed together with both heels touching the base of the vertical board, the buttocks, scapulae, and head were positioned in contact with the vertical backboard. The subject was asked to inhale deeply and to stand fully erect without altering the position of the heels. The subject’s head was maintained in the Frankfort Horizontal Plane position while the examiner lowered the horizontal bar snugly to the crown of the head with sufficient pressure to compress the hair. The bar was locked in place and the height was read to the nearest 0.1m on the graduated height scale (stadiometer).^97,99

The weight measurements were to the nearest 0.5 kg on a standard scale with the subject wearing light outdoor clothing and no shoes. The scale was placed on a firm, flat surface and the subjects asked to step onto the scale with one foot on each side of the scale. The subjects were to stand still, face forward, place arms on the side and wait until their weight was read off the scale before stepping off.⁹⁷

The results were classified as follows¹⁰⁰:

Classification BMI (kg/m2) Underweight < 18.5

Normal 18.5- 24.99 Overweight 25- 29.99 Obese ≥ 30.0

3.12.4 BLOOD PRESSURE

Blood pressure was recorded on the arm of the seated participants with a mercury-column sphygmomanometer and an appropriately sized cuff after resting for 5-15mins. The subjects were asked to remove/roll up clothing that covers the location of cuff placement. They were made to be comfortably seated, with the legs uncrossed, and the back and arm supported, such that the middle of the cuff on the upper arm was at the level of the heart. The subjects were instructed to relax as much as possible and to not talk during the measurement procedure.^97,101 The blood pressure was taken on both arms and the arm with the higher reading was used, the average of two obtained measures constituted the examination BP.^101,102

Systolic blood pressure and Diastolic blood pressure were determined using phase I and V korotkoff sounds. Systemic hypertension was defined as SBP equal to or greater than 140mmHg and/or DBP equal to or greater than 90mmHg or being on pharmacological treatment for hypertension.^101,102 The different grades of hypertension were defined as follows: mild (140/90mmHg to 159/99mmHg), moderate (160/100 to 179/109mmHg), and severe hypertension (≥180/110mmHg).¹⁰²

48 3.13 LABORATORY MEASUREMENTS

The laboratory investigations that were carried out in this study include- fasting plasma glucose (FPG) and 2-hour postprandial glucose (in the diabetic group), fasting lipid profile, glycated haemoglobin, serum creatinine and urinalysis for proteinuria/microalbuminuria.

3.13.1 PLASMA GLUCOSE

Plasma glucose (FPG & 2-hour postprandial) was measured using the spectrophotometer 2100 with the aid of glucose oxidase preparation supplied by RANDOX Laboratory Ltd., United Kingdom using the principle of Trinder reaction as described below. Enzymatic indicator test based on the Trinder reaction were quantified by the formation of a pink quinoneimmine dye. In this reaction plasma glucose is determined after enzymatic oxidation in presence of glucose oxidase (GOD). The hydrogen peroxide formed is catalyzed by peroxidase (POD) and reacts with phenol and 4-aminoantipyrine to form the dye indicator. The absorbance of the dye- indicator formed was measured by the spectrophotometer to determine the plasma glucose levels.

In this study subjects were considered to have poor glycaemic control if they had fasting plasma glucose (FPG) >7.2mmol/L, 2-hour postprandial blood glucose (2HrPP) >10mmol/L and

glycated hemoglobin (HBA1c) >7%.¹⁰³

49 3.13.2 SERUM LIPIDS

Serum total cholesterol, triglyceride and HDL-c levels were determined with standardized enzymatic methods and the value of the low density lipoprotein cholesterol [LDL-c] was calculated using the Friedewald’s formula as stated below¹⁰⁴:

LDL-Cholesterol (mgldl) = Total Cholesterol − HDL-Cholesterol – Triglyceride/5

Serum LDL-c quantification using the Friedewald’s formula is simple, reliable and cost effective however, it has a limitation of under-estimating LDL-c when triglyceride is > 400mg/dl. In this situation LDL-c can be quantified directly or by the use of modified formulas.¹⁰⁴ In this study, no triglyceride value was > 400mg/dl.

3.13.3 GLYCATED HAEMOGLOBIN

Glycated haemoglobin was estimated quantitatively using reagent from Teco diagnostics 1268 N.

Lakeview. Anaheim, CA 92807. A hemolysed preparation of the whole blood is mixed continuously for 5 minutes with a weak binding cation-exchange resin. During this time, HbAo (unglycated haemoglobin) binds to the resin. After the mixing period, a filter is used to separate the supernatant containing the glycohaemoglobin from the resin. The percent glycohaemoglobin is determined by measuring the absorbance at 415nm of the glycohaemoglobin fraction and the total haemoglobin fraction. The ratio of the two absorbances gives the percent glycohaemoglobin.

The results were classified as < 7.0% (good control) and ≥7.0% (poor control).¹⁰⁵

50 3.13.4 SERUM CREATININE

Serum creatinine was determined by enzymatic method using the Spectrophotometer 2100. This was determined by photometry following its reactions with picric acid to form a colored compound, creatinine alkaline picrate. The change in absorbance (at a wavelength of 490nm) is proportional to the creatinine concentration. The result was used to estimate GFR.

Estimated GFR: This was calculated according to the Cockcroft and Gault formula¹⁰⁶ SF x [140- Age (years)] x weight(kg) x1.73

1000 x Scr x BSA

Where SF is 1.23 for men and 1.05 for women; Scr = Serum creatinine,

BSA = body surface area = 0.0007184 X height (cm) (0.725) X weight (kg) (0.425).

3.13.5 MICROALBUMINURIA

Mid-stream urine sample was collected in a confidential spot for proteinuria using Combi 10 urine dipstick. In patients with negative protein dipstick results, microalbuminuria was determined semi–quantitatively using the Micral test strips. Micral test strip is a reliable semi-quantitative determination of low albumin concentrations in urine samples. The Micral test defines microalbuminuria as 20-200mg/L.

3.14 QUALITY CONTROL OF LABORATORY METHODS AND COEFFICIENTS OF VARIATION (ACCURACY AND PRECISION CONTROLS)

Analytical accuracy and precision were ensured by simultaneous analysis of commercially prepared controls in each batch of samples that was analyzed. All plasma and urine specimens were analyzed in batches at the central Chemical Pathology laboratory of the hospital. Control sera were purchased from Randox Laboratories limited, United Kingdom, BT29 4QY.

Spectrophotometric assay reagent kits for fasting lipid profile and glucose were purchased from Randox Laboratories limited, United Kingdom, BT29 4QY, while glycated haemoglobin was purchased from Teco diagnostics 1268 N. Lakeview. Anaheim, CA 92807. Intra-assay, inter-assay, and day-to-day coefficients of variation were estimated for each batch of analytes and were ensured to be within allowable limits of acceptance for each analyte (Appendix I).

52 3.15 DEFINITION OF TERMS

1. Type 2 diabetes mellitus subjects were all previously diagnosed or newly diagnosed subjects with diabetes mellitus based on WHO classification and diagnostic criteria.^94,107 2. Cardiovascular diseases are a group of disorders of the heart and blood vessels and

cardiovascular risk factors are attributes or characteristics of an individual that promote development of future cardiovascular disease.¹²

3. Controlled subjects with T2DM were taken as subjects with HbA1C < 7.0% while the uncontrolled subjects were those with HbA1C ≥ 7.0%.¹⁰⁵

4. Overweight/ Obesity were regarded as BMI of 25-29.99 and ≥ 30 respectively.¹⁰⁰

5. Waist/hip ratio (WHR) > 0.85 for females and > 0.90 for males were considered abnormal.⁹⁸

6. Cardiometabolic syndrome (CMS) is a complex cluster of risk factors for cardiovascular disease (CVD) and diabetes.⁸³ The criteria used for clinical diagnosis of CMS in this study was 3 of 5 of the following^48,108:

Abdominal obesity Waist Circumference

Men > 102 cm (> 40 in) Women > 88 cm (> 35 in) Elevated triglycerides (drug treatment for elevated

triglycerides is an alternate indicator)

≥ 150 mg/dL (1.7 mmol/L)

Reduced HDL-C (drug treatment for reduced HDL-C < 40 mg/dL (1.03 mmol/L) in

is an alternate indicator) males; < 50 mg/dL (1.3 mmol/L) in females

Elevated blood pressure (antihypertensive drug treatment in a patient with a history of hypertension is an alternate indicator)

Systolic ≥ 130 and/or diastolic ≥ 85 mm Hg

Elevated fasting glucose (drug treatment of elevated glucose is an alternate indicator)

≥ 100 mg/dL

7. Dyslipidaemia was classified as follows⁴⁸:

Total Cholesterol (mg/dl) < 200 Desirable 200-239 Borderline High

≥ 240 High

Triglyceride (mg/dl) < 150 Normal

150-199 Borderline High 200-499 High

≥ 500 Very High HDL-c (mg/dl) < 40 Low (Male)

< 50 Low (Female)

≥ 60 High (desirable)

LDL-c (mg/dl) < 100 Optimal 100-129 Near Optimal /

Above Optimal

130-159 Borderline High 160-189 High

≥ 190 Very High

54 Atherogenic index

(TC/HDL-c)

< 4.0 Optimal 4.0-5.0 Borderline

> 6.0 High risk

3.16 DATA ANALYSIS

Statistical analysis was done using the Personal Computer (PC) analytical software, Statistical Package for Social Sciences (SPSS Inc, Chicago, IL) version 22. Results were expressed as either mean values (standard deviation) or proportions, and comparison for statistical significance was by student’s t-test for continuous variables or chi-square analysis for categorical variables.

Chi-square analysis was used to compare the prevalence of cardiometabolic risk factors in patients with type 2 diabetes mellitus and apparently healthy controls. Correlation analysis was used to determine the relationship between measures of glycaemic control and cardiometabolic risk factors in patients with type 2 diabetes mellitus while logistic regression was used to estimate the association between the cardiometabolic risk factors and glycaemic control.

The significance level was set at P ≤ .05.

CHAPTER FOUR RESULTS

4.1 FLOW CHART THROUGH THE STUDY.

In this study, 204 subjects were recruited in the group with type 2 DM but 4 dropped out with 200 completing the study while 112 were recruited as controls; however. 12 were not age and sex matched and were dropped, so 300 subjects completed both arms of the study giving a response rate of 96.2%.

Total subjects seen = 316

Inclusion

Exclusion criteria

Not matched = 12 (controls) Excluded = 4 (patients)

300

Non-Probability sampling method

Figure 1: Flow chart of all participants throughout the study

Study 45

Control 45

200 100

Figure 2 shows a pie chart of the distribution of subjects in the study group by the clinics they attended. 73% of the subjects attended the Endocrinology Medical Out-Patient Clinic while the remaining 27% attended General Out-Patient Clinic.

Figure 2: Pie chart showing distribution of subjects in the study group by the clinic attended

58 4.2 DEMOGRAPHIC FEATURES

Table 1a shows the age and gender distribution of subjects and controls. In both groups, most of the subjects were females and were within the age groups 50-59 and ≥ 60years. In the control group, there was a statistically significant difference in the age distribution between the genders with a p-value of 0.024, but this was not statistically significant in the group with T2DM.

Table 1b shows the demographic characteristics of the study subjects. The mean age of T2DM patients was 56.4 ± 9.4years, while that of the control group was 54.8 ± 10.5years, but this difference was not statistically significant (t = 1.118, p = 0.264). The age range was 30 and 65 years in both study groups.

The proportion of males and females studied in both T2DM group and control group were similar (p- 0.897) as shown in Table 1b. Similarly, there were no significant differences between the two groups in marital status, ethnicity and level of education.

Table 1a: Age and Gender distribution of subjects and controls

Variable Subject Control

Male n = 68

Female n = 132

Male n = 33

Female n = 67

Age Group (in years)

30 – 39 8 (11.8) 9 (6.8) 7 (21.2) 5 (7.5)

40 – 49 10 (14.7) 14 (10.6) 7 (21.2) 10 (14.9)

50 – 59 15 (22.1) 42 (31.8) 3 (9.1) 22 (32.8)

≥60 35 (51.4) 67 (50.8) 16 (48.5) 30 (44.8)

‡ Fisher’s Exact Test; χ² = 3.425, p =0.331, p =0.024^‡

Table 1b: Socio – demographic characteristics of subjects with and without type 2 DM

Variable With

T2DM (%) (N = 200)

Without T2DM (%) (N = 100)

Total (%)

N = 300 χ² p – value Age (in years)

30 – 39 17 (8.5) 12 (12.0) 29 (9.8) 2.259 0.330

40 - 49 24 (12.0) 17 (17.0) 41 (13.7)

50 – 59 57 (28.5) 25 (25.0) 82 (27.3)

60+ 102 (51.0) 46 (46.0) 148 (49.3)

Mean ± SD 56.4 ± 9.4 54.8 ± 10.5 55.9 ± 9.8 1.118 0.264^† Sex

Male 68 (34.0) 33 (33.0) 101 (33.7) 0.030 0.897

Female 132 (66.0) 67 (67.0) 199 (66.3)

Marital Status

Single 1 (0.5) 2 (2.0) 3 (1.0) 0.092^‡

Married 152 (76.0) 77 (77.0) 229 (76.3)

Divorced 1 (0.5) 4 (4.0) 5 (1.7)

Separated 5 (2.5) 1 (1.0) 6 (2.0)

Widowed 41 (20.5) 16 (16.0) 57 (19.0)

Ethnicity

Yoruba 195 (97.5) 95 (95.0) 290 (96.7) 1.293 0.255

Others 5 (2.5) 5 (5.0) 10 (33.3)

Level of Education

None 41 (20.5) 11 (11.0) 52 (17.3) 5.673 0.130

Primary 41 (20.5) 19 (19.0) 60 (20.0)

Secondary 34 (17.0) 16 (16.0) 50 (16.7)

Tertiary 84 (42.0) 54 (54.0) 138 (46.0)

† Mann – Whitney U Test ‡ Fisher’s Exact Test T2DM- type 2 diabetes mellitus SD- standard deviation

Figure 3 shows distribution of the subjects by religion, there was no statistically significant difference between the study and the control groups (p-value- 0.454).

Figure 4 shows distribution of respondents by occupation, there was a statistically significant difference in the occupation of subjects in the study and control group (p-value- 0.000).

61 Figure 3: Distribution of respondents by religion

Figure 4: Distribution of respondents by occupation

4.3 COMPARISON OF CLINICAL FACTORS AMONG THE GROUPS

Table 2 compares some clinical cardiometabolic risk factors among the two groups. Waist circumference was higher among females with T2DM but this was not statistically significant (p-value- 0.062), waist-hip ratio was however, higher in both males and females with T2DM when compared with controls and this was statistically significant (p-value- <0.001, 0.001). Body mass index, systemic hypertension and consumption of alcohol were also higher in the type 2 DM group than the control group and these were also statistically significant (p-value- 0.021, <0.001, 0.003 respectively). Smoking status was however similar in the two groups.

Table 2: Comparison of cardiometabolic risk factors among subjects with and without type 2 DM

Variable With

T2DM (%) (N = 200)

Without T2DM (%) (N = 100)

Total (%)

N = 300 χ² P

Waist Circumference MALE:

Abnormal 16 (23.5) 3 (9.1)) 19 (18.8) 0.082^‡

Normal 52 (78.5) 30 (90.9) 82 (81.2)

FEMALE:

Abnormal 96 (72.7) 40 (59.7) 136 (68.3) 3.485 0.062

Normal 36 (27.3) 27 (40.3) 63 (31.7)

Waist Hip Ratio MALE

Abnormal 59 (86.8) 17 (51.5) 76 (75.3) 14.821 <0.001

Normal 9 (13.2) 16 (48.5) 25 (24.7)

FEMALE

Abnormal 107 (81.1) 40 (59.7) 147 (73.9) 10.503 0.001

Normal 25 (18.9) 27 (40.3) 52 (26.1)

Body Mass Index

Underweight 2 (1.0) 1 (1.0) 3 (0.0) 0.021^‡

Normal weight 43 (21.5) 37 (37.0) 80 (26.7)

Over weight 94 (47.0) 42 (42.0) 136 (45.3)

Obese 61 (30.5) 20 (20.0) 81 (27.0)

Hypertension

Yes 137 (68.5) 33 (33.0) 170 (56.7) 34.215 <0.001

No 63 (31.5) 67 (67.0) 130 (43.3)

Smoking cigarette

Yes 13 (6.5) 6 (6.0) 19 (6.3) 0.028 1.000

No 187 (93.5) 94 (94.0) 281 (93.7)

Drinking alcohol

Yes 70 (35.0) 18 (18.0) 88 (29.3) 9.295 0.003

No 130 (65.0) 82 (82.0) 212 (70.7)

‡ Fisher’s Exact Test; T2DM- type 2 diabetes mellitus

Waist circumference: Normal <88cm in females, <102cm in males, Abnormal >88cm in females,

>102cm in males

4.4 COMPARISON OF BIOCHEMICAL PARAMETERS AMONG THE TWO GROUPS Table 3 compared some biochemical parameters among the two groups. Total cholesterol, triglyceride, low density lipoprotein-cholesterol and atherogenic index were all higher in the group with T2DM and these were all statistically significant (p-values- 0.036, 0.014, 0.014 and 0.019 respectively). The level of high density lipoprotein-cholesterol was lower in males with T2DM but this was not statistically significant while in females it was lower and statistically significant (p-values- 0.157, 0.011 respectively).

Proteinuria (dipstick) was positive in 110 (55%) of the subjects with T2DM and in 36 (36%) in the group without T2DM and this was statistically significant (p-value- 0.002). Of the 90 subjects with negative proteinuria on dipstick, 32 (35.6%) of the group with T2DM and 17 (26.6%) of the group without T2DM had microalbuminuria; this was however not statistically significant (p-value- 0.238). Estimated glomerular filtration rate (eGFR) was lower in the group with T2DM and was statistically significant (p-value- 0.007).

Table 3: Comparison of some biochemical parameters among subjects with and without type 2 DM

Variable With

T2DM (%) (N = 200)

Without T2DM (%) (N = 100)

Total (%)

N = 300 χ² P

HDL MALE:

Low 37 (54.4) 13 (39.4) 50 (49.5) 2.004 0.157

High 31 (45.6) 20 (60.6) 51 (50.5)

FEMALE:

Low 49 (37.1) 13 (19.4) 62 (31.2) 6.504 0.011

High 83 (62.9) 54 (80.6) 137 (68.8)

LDL

Very high 54 (27.0) 14 (14.0) 68 (22.7) 12.517 0.014

High 25 (12.5) 15 (15.0) 40 (13.3)

Borderline high 33 (16.5) 12 (12.0) 45 (15.0) Near/ Above Optimal 41 (20.5) 19 (19.0) 60 (20.0)

Optimal 47 (23.5) 40 (40.0) 87 (29.0)

High 73 (36.5) 24 (24.0) 97 (32.3) 6.679 0.036

Borderline high 34 (17.0) 14 (14.0) 48 (16.0)

Desirable 93 (46.5) 62 (62.0) 155 (51.7)

High 22 (11.0) 2 (2.0) 24 (8.0) 8.368 0.014^‡

Borderline high 18 (9.0) 8 (8.0) 26 (8.7)

Normal 160 (80.0) 90 (90.0) 250 (83.3)

TC/HDL

High risk 40 (20.0) 11 (11.0) 51 (17.0) 7.816 0.019

Borderline 61 (30.5) 23 (23.0) 84 (28.0)

Optimal 99 (49.5) 66 (66.0) 165 (55.0)

Proteinuria

Positive 110 (55.0) 36 (36.0) 146 (48.7) 9.634 0.002

Negative 90 (45.0) 64 (64.0) 154 (51.3)

Microalbuminuria (n=154)

Yes 32 (35.6) 17(26.6) 49 (31.8) 1.394 0.238

No 58 (64.4) 47(73.4) 105 (68.2)

eGFR

<15 1 (0.5) 0 (0.0) 1 (0.3) 15.588^LR 0.007^‡

15 – 29 8 (4.0) 0 (0.0) 8 (2.7)

30 – 59 65 (32.5) 23 (23.0) 88 (29.3)

60 – 89 76 (38.0) 35 (35.0) 111 (37.0)

≥90 50 (25.0) 42 (42.0) 92 (30.7)

LR – Likelihood Ratio ‡ Fisher’s Exact Test T2DM- type 2 diabetes mellitus HDL- high density lipoprotein LDL- low density lipoprotein TC- total cholesterol

TG- triglyceride TC/HDL- atherogenic index eGFR- estimated glomerular filtration rate

4.5 COMPARISON OF CARDIOMETABOLIC RISK FACTORS AMONG SUBJECTS WITH AND WITHOUT TYPE 2 DIABETES MELLITUS

Figure 4 shows a bar chart comparing metabolic syndrome occurrence among the subjects with and without type 2 DM. The frequency of metabolic syndrome was significantly higher in subjects with type 2 DM (p-value- 0.000).

Figure 5: Bar chart comparing metabolic syndrome in subjects with and without type 2 DM

4.6 GLYCAEMIC CONTROL IN THE TYPE 2 DIABETES MELLITUS SUBJECTS Figure 5 shows glycaemic control in the type 2 DM subjects. Of the 200 subjects with T2DM, using fasting plasma glucose (FPG), 93 (46.5%) had good glycaemic control while 107 (53.5%) had poor control, using glycated haemoglobin 95 (47.5%) had good control and 105 (52.5%) were poorly controlled but the 2-hour post-prandial blood glucose (2HrPP) however, showed only 82 (41%) had good glycaemic control and 118 (59%) were poorly controlled.

Figure 6: Bar chart showing glycaemic control in the respondents with type 2 DM

4.7 ASSOCIATION BETWEEN SOCIO-DEMOGRAPHIC CHARACTERISTICS OF RESPONDENTS IN THE GROUP WITH TYPE 2 DM AND GLYCAEMIC CONTROL Table 4a shows association between socio-demographic characteristics of respondents in the group with T2DM and glycaemic control using fasting plasma glucose.

Subjects with poor glycaemic control were more in the older age group but this was not statistically significant (p-value- 0.793). More females had poor glycaemic control but this was also not statistically significant (p-value- 0.190). There was no statistically significant difference

in glycaemic control with respect to ethnicity, however more subjects with tertiary level of education had poor glycaemic control and this was statistically significant (p- values- 0.576, 0.012 respectively).

Table 4a: Association between socio-demographic characteristics and level of glycaemic control using fasting plasma glucose

Fasting Plasma Glucose

Variable Good Control

n = 93 (%)

Poor Control n = 107 (%)

Total (%) N = 200

χ² p

Age (in years)

30 – 39 6 (6.5) 11 (10.3) 17 (8.5) 1.032 0.793

40 - 49 11 (11.8) 13 (12.2) 24 (12.0)

50 – 59 28 (30.1) 29 (27.1) 57 (28.5)

60+ 48 (51.6) 54 (50.4) 102 (51.0)

Sex

Male 36 (38.7) 32 (29.9) 68 (34.0) 1.718 0.190

Female 57 (61.3) 75 (70.1) 132 (66.0)

Ethnicity

Yoruba 92 (98.9) 103 (96.3) 195 (97.5) 0.576*

Others 1 (1.1) 4 (3.7) 5 (2.5)

Level of Education

None 17 (18.3) 24 (22.4) 41 (20.5) 10.984 0.012

Primary 25 (26.9) 16 (15.0) 41 (20.5)

Secondary 21 (22.6) 13 (12.1) 34 (17.0)

Tertiary 30 (32.2) 54 (50.5) 84 (42.0)

*Fisher’s Exact Test

Table 4b shows the association between socio-demographic characteristics of respondents in the group with T2DM and glycaemic control using 2-hour postprandial glucose.

Subjects with poor glycaemic control were more in the older age group but this was not statistically significant (p-value- 0.175). A higher proportion of females had poor glycaemic control and this was statistically significant (p-value- 0.000). There was no statistically significant difference in glycaemic control with respect to ethnicity and level of education (p-values- 0.531, 0.101 respectively).

In document El impacto del Bono de Desarrollo Humano en la educación en Ecuador, como programa de transferencia monetaria condicionada, año 2012 (página 43-46)