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4.4 STUDY PERIOD

  Preparatory Phase – ( 3 ) months

  Data collection – ( 1 ) year and ( 6 ) months

  Data analysis and report writing – ( 6 ) months

Year 2009 2010 2011

Month

       c    t   o    !   e   r

    "   o   #   e   m    !   e   r

    D   e   c   e   m    !   e   r

    $   a   n   %   a   r   y

    &   e    !   r   %   a   r   y

    M   a   r   c    h

    '   p   r    i    l

    M   a   y

    $   %   n   e

    $   %    l   y

    '   %   g   %   s    t

    (   e   p    t   e   m    !   e   r

       c    t   o    !   e   r

    "   o   #   e   m    !   e   r

    D   e   c   e   m    !   e   r

    $   a   n   %   a   r   y

    &   e    !   r   %   a   r   y

    M   a   r   c    h

    '   p   r    i    l

    M   a   y

    $   %   n   e

    $   %    l   y

Preparatory

Phase

Data

ollection

Data

'nalysis*

+eport

,riting

2-

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4.5 SAMPLE SIZE

 Sample size = minimum 60

. /y %sing sample sie determination in health st%dies , ene#a 19914

&or 95 on7idence inter#al

n 8 2  p

  d2 

n 8 ( 1496 )2  ( 0465 ) ( 0435 ) * ( 041)2 

8 6043

,here

n8 minim%m re%ired sample sie 7or 95 con7idence le#el

8 1496

 p 8 pre#alence o7 cardiac a%tonomic ne%ropathy in

type 2 dia!etes mellit%s

  8 6043

8 pre#alence o7 cardiac a%tonomic ne%ropathy in

type 2 dia!etes mellit%s

  8 1.p 8 0435

D 8 margin o7 error 8 041

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4.6 MATERIALS AD MET!ODS

4.6." I#LUSIO #RITERIA

". 'll type 2 dia!etic patients who meet 'D' 2010 criteria

$. 'ge -0 year to :0 years

%. /oth se;es

4.6.$ ELUSIO #RITERIA

Patients with

". 'ny pre;isting heart diseases

$. P%lmonary disease

%. istory o7 recent (preceding two wee

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4.' RESEAR#! PRO#EDURE

• >ype 2 dia!etes mellit%s patients who 7%l7illed the incl%sion criteria were

recr%ited at dia!etic clinic clinic o7 "o (2) D (1000./edded) and "o (2)

M (500./edded)4

•  'mong them the patients who meet the e;cl%sion criteria (i4e4 patients not

s%ita!le 7or cardio#asc%lar response tests (7or e;ample – ischaemic heart disease

and myocardial in7arct) were r%led o%t 7rom this st%dy4

• 'ccording ?wing=s criteria 7ollowing 7i#e cardio#asc%lar a%tonomic 7%nction

tests will !e per7ormed as 7ollowing4 'nd the res%lts o7 these 7i#e tests will !e will

 !e noted down and interpreted with ?wing=s classi7ication4

4.'." !ea() (a)e (esp*nse )* +eep ,(ea)-in / i.e ,ea) )* ,ea) a(ia)i*n 1R2R

a(ia)i*n3

>he patient lies %ietly and !reathes deeply at a rate o7 si; !reaths per min%te

(7i#e seconds in and 7i#e seconds o%t a rate that prod%ces ma;im%m #ariation in heart

rate ) while a heart monitor records the di77erence !etween the ma;im%m and minim%m

heart rates with a marhe ma;im%m and minim%m +.+ inter#als d%ring each !reathing cycle were meas%red

with @ernier caliper and con#ered to !eats*min the res%lts were then e;pressed as the

mean o7 the di77erence !etween ma;im%m and minim%m heart rate 7or the si; meas%red

cycles in !eats per min%te4

4.'.% !ea() (a)e (esp*nse )* s)an+in

>he patient is connected an electrocardiogram (?) monitor while lying down

and then stands to a 7%ll %pright position4 ? tracings are %sed to determine the 30A15

ratios calc%lated as the ratio o7 the longest +.+ inter#al ( 7o%nded at a!o%t !eat 30 ) to

the shortest +.+ inter#als may not always occ%r at e;actly the 15th or 30th !eats a7ter

2:

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standing4 >he ma;im%m Bminim%m 30A15 ratio as the longest +.+ inter#al d%ring !eats

20.-0 di#ided !y the shortest +.+ inter#al d%ring !eats 5.254

4.'.4 !ea() (a)e (esp*nse )* alsala maneue(

>he test was per7ormed !y the patient !lowing into the mo%th piece connected to

the modi7ied sphygmomanometer and maintained it at a press%re o7 -0 mmg 7or 15

seconds while contin%o%s ? was !eing recorded in lead CC4 are was tahe

mane%#er was per7ormed three times with one min%te inter#al !etween4 >he @alsal#a

ratio is determined 7rom ? tracings !y calc%lating the ratio o7 the longest +.+ inter#al

a7ter the mane%#er (re7lecting the !radycardic response to !lood press%re o#ershoot) the

shortest +.+ inter#al d%ring or shortly a7ter the mane%#er (re7lecting tachycardia as a

res%lt o7 strain)4

4.'.5 Ss)*li ,l**+ p(essu(e (esp*nse )* s)an+in

>he systolic !lood press%re di77erences !etween the lying and standing were ta

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-44241 aemoglo!in '1E 6454 >he test sho%ld !e per7ormed in a

la!oratory %sing a method that is "P certi7ied and

standardied to the D> assay4F + 

-44242 &asting Plasma l%cose E 126mg*dl (:40 mmol*l) 4&asting is

de7ined as no caloric intawo.ho%r plasma gl%coseE 200mg*dl(1141mmol*l) d%ring an

>>4 >he test sho%ld !e per7ormed as descri!ed !y the ,

%sing a gl%cose load containing the e%i#alent o7 :5g anhydro%s

gl%cose dissol#ed in water4 +

-4424- Cn a patient with classic symptoms o7 hyperglycemia or

hyperglycemic crisis a random plasma gl%coseE200 mg*dl (1141

mmol*l)4

Cn the a!sence o7 %ne%i#ocal hyperglycemia criteria 1.3 sho%ld !e con7irmed !y

repeat testing4

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4.7.$ Ta,le /"3 Ein>s (i)e(ia an+ in)e(p(e)a)i*n *? a(+i*asula( (e?le@es )es)s

*? au)*n*mi neu(*pa)- /Ein DB "C'%3

?#al%ation o7 the res%lts

>he res%lts were then categoried into 7o%r gro%ps4

14 "ormal (grade C)4

24 ?arly parasympathetic damage with the res%lts o7 one o7 the three tests o7

 parasympathetic 7%nction a!normal (grade CC)4

34 De7ined parasympathetic damage with the res%lts o7 at least two o7 the tests o7

 parasympathetic 7%nction a!normal (grade CCC)4

30

 "ormal /orderline a!normal

Tes) (e?le)in )-e a(+i*asula( ?un)i*n 

@alsal#a ratioG1421

 1411.1420 H1410

eart rate (+.+)inter#al #ariation

d%ring deep !reathing

(!eat*min)

G15 11.1- H10

Cmmediate response to

standing4 G140-

1401. 1403 H1400

Tes) (e?le)in smpa)-e)i ?un)i*n

/lood press%reresponse to standing

(mmg)

H10 11.29 G30

/lood press%reresponse s%stained

handgrip (mmg)

G16 11.15 H10

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-4 om!ined parasympathetic and sympathetic damage where in addition to

a!normal parasympathetic res%lt 7indings in one or !oth o7 the sympathetic tests

are a!normal (grade C@)4

>hese grading can !e categoried into three gro%p as (1) "ormal 7or grade C (2) ?arly

'" 7or grade CC and (3) De7ined '" 7or grade CCC and C@4

4.C Da)a Analsis

't the end o7 the st%dy data was calc%lated with P so7tware #ersion 1640 and

analyed with Pearson correlation coe77icient and > test whene#er appropriate4 P #al%e

I0405 were considered signi7icant4 >a!le and diagrams were %sed as necessary4

4."0. E)-ial *nsi+e(a)i*ns

Cn7ormed consent was o!tained 7rom all patients4

?thical clearance was re%ested 7rom the M Med c4 (Cnt4Med4) post grad%ate

 !oard o7 st%dies De7ence er#ices Medical 'cademy4

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