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    10.5 Methodology 2

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    Ye Htun
    The document describes a study period for a research project on cardiac autonomic neuropathy in type 2 diabetes patients. It involves 3 phases: 1) A data collection phase lasting from 3 months to 1.5 years. 2) A 6 month data analysis and report writing phase. 3) The study will take place between 2009-2011.

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    10.5 Methodology 2

    Uploaded by

    Ye Htun
    42 views8 pages
    The document describes a study period for a research project on cardiac autonomic neuropathy in type 2 diabetes patients. It involves 3 phases: 1) A data collection phase lasting from 3 months to 1.5 years. 2) A 6 month data analysis and report writing phase. 3) The study will take place between 2009-2011.

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    The document describes a study period for a research project on cardiac autonomic neuropathy in type 2 diabetes patients. It involves 3 phases: 1) A data collection phase lasting from 3 months to 1.5 years. 2) A 6 month data analysis and report writing phase. 3) The study will take place between 2009-2011.

    Copyright:

    Attribution Non-Commercial (BY-NC)
    Download as DOC, PDF, TXT or read online from Scribd
    Download as doc, pdf, or txt
    42 views8 pages

    10.5 Methodology 2

    Uploaded by

    Ye Htun
    The document describes a study period for a research project on cardiac autonomic neuropathy in type 2 diabetes patients. It involves 3 phases: 1) A data collection phase lasting from 3 months to 1.5 years. 2) A 6 month data analysis and report writing phase. 3) The study will take place between 2009-2011.

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    4.

    4 STUDY PERIOD
    Preparatory Phase Data collection ( 3 ) months ( 1 ) year and ( 6 ) months

    Data analysis and report writing ( 6 ) months Year Month 2009 2010 2011

    (eptem!er

    Preparatory Phase Data )ollection Data 'nalysis* +eport ,riting

    2-

    (eptem!er

    "o#em!er

    "o#em!er

    Decem!er

    Decem!er

    &e!r%ary

    &e!r%ary

    cto!er

    $an%ary

    cto!er

    $an%ary

    '%g%st

    '%g%st

    March

    March

    'pril

    'pril

    $%ne

    $%ne

    May

    May

    $%ly

    $%ly

    4.5 SAMPLE SIZE


    Sample size = minimum 60 . /y %sing sample si0e determination in health st%dies 1 ,2 3ene#a 19914 &or 95 6 )on7idence inter#al1 n 8 02 p 9 d2 n 8 ( 1496 )2 ( 0465 ) ( 0435 ) * ( 041)2 8 6043 ,here1 n8 minim%m re9%ired sample si0e 7or 956 con7idence le#el 0 8 1496 p8 8 98 8 D8 pre#alence o7 cardiac a%tonomic ne%ropathy in type 2 dia!etes mellit%s 6043 6 pre#alence o7 cardiac a%tonomic ne%ropathy in type 2 dia!etes mellit%s 1.p 8 0435 margin o7 error1 8 041

    25

    4.6
    4.6."

    MATERIALS A D MET!ODS
    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.$

    E&#LUSIO #RITERIA Patients with ". $. %. 'ny pre;isting heart diseases P%lmonary disease 2istory o7 recent (preceding two wee<s) medication with . sympathomimetic dr%gs s%ch as adrenalin1 do!%tamine1 dopamine hydrochloride1 dope;amine hydrochloride4 . antiarrhythmic dr%gs s%ch as 9%inidine1 lidocaine1 !isoprolol1 7lecainide . !eta !loc<ers s%ch as esmolol1 propranolol1 sotalol1 amiodarone1 . ganglion !loc<ers s%ch as trimetaphan . calci%m channel !loc<er s%ch as #erapamil1 diltia0em . cardiac glycosides s%ch as digo;in1 digito;in 4 . tricyclic antidepressant s%ch as amitriptyline1 amo;apine1 imipramine1clomipramine1 nortriptylline 4. )onditions that can gi#e rise to central and peripheral a%tonomic ne%ropathy s%ch as ne%rosysphilis1 leprosy1 3%illain /arre=s syndrome1 par<insonism and alcoholism4

    26

    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(321 (1000./edded) and "o (2) M21 (500./edded)4 'mong them1 the patients who meet the e;cl%sion criteria (i4e41 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 criteria1 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) 0a(ia)i*n 1R2R 0a(ia)i*n3 >he patient lies 9%ietly and !reathes deeply at a rate o7 si; !reaths per min%te

    (7i#e seconds in and 7i#e seconds o%t1 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 rates1 with a mar<er %sed to indicate the onset o7 each inspiration and e;piration4 >he ma;im%m and minim%m +.+ inter#als d%ring each !reathing cycle were meas%red with @ernier caliper and con#ered to !eats*min1 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 (?)3) monitor while lying down and then stands to a 7%ll %pright position4 ?)3 tracings are %sed to determine the 30A15 ratios1 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:

    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 )* 4alsal0a maneu0e( >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 mm2g 7or 15 seconds while contin%o%s ?)3 was !eing recorded in lead CC4 )are was ta<en that the press%re rose sharply and 7ell a!r%ptly at the termination o7 the strain period4 >he mane%#er was per7ormed three times with one min%te inter#al !etween4 >he @alsal#a ratio is determined 7rom ?)3 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 S5s)*li6 ,l**+ p(essu(e (esp*nse )* s)an+in. >he systolic !lood press%re di77erences !etween the lying and standing were ta<en as the post%ral press%re response to standing4 4.'.6 Dias)*li6 ,l**+ p(essu(e (esp*nse )* sus)aine+ -an+.(ip >he dynamometer is 7irst s9%ee0ed to isometric ma;im%m1 and then held at 306 ma;im%m 7or 5 min%te4 >he !lood press%re was meas%red in the other arm three times !e7ore and at one min%te inter#als d%ring hands grip4 >he res%lts were e;pressed as the di77erence !etween the highest diastolic !lood press%re d%ring hand grip e;ercise and the mean o7 the diastolic !lood press%re readings !e7ore hand grip4 4.7 4.7." 8OR9I : DE;I ITIO S #RITERIA ;OR T!E DIA: OSIS O; DIA<ETES /ADA $0"03 >he presence o7 dia!etes was !ased on a history o7 dia!etes1 either c%rrent or pre#io%s 7asting gl%cose le#el o7 126 mg*dl or higher1 or c%rrent or pre#io%s %se o7 antihyperglycaemic medication4 ($oseph &1 2010) or according to 'D' 2010 criteria 2D

    -4D4241 2aemoglo!in '1)E 64564 >he test sho%ld !e per7ormed in a la!oratory %sing a method that is "3(P certi7ied and standardi0ed to the D))> assay4F de7ined as no caloric inta<e 7or at least D h4F + + -4D4242 &asting Plasma 3l%cose E 126mg*dl (:40 mmol*l) 4&asting is

    -4D4243 >wo.ho%r plasma gl%coseE 200mg*dl(1141mmol*l) d%ring an 3>>4 >he test sho%ld !e per7ormed as descri!ed !y the ,2 1 + %sing a gl%cose load containing the e9%i#alent o7 :5g anhydro%s gl%cose dissol#ed in water4

    -4D424- Cn a patient with classic symptoms o7 hyperglycemia or hyperglycemic crisis1 a random plasma gl%coseE200 mg*dl (1141 mmol*l)4 Cn the a!sence o7 %ne9%i#ocal hyperglycemia1 criteria 1.3 sho%ld !e con7irmed !y repeat testing4

    29

    4.7.$

    Ta,le /"3 E=in.>s 6(i)e(ia an+ in)e(p(e)a)i*n *? 6a(+i*0as6ula( (e?le@es )es)s

    *? au)*n*mi6 neu(*pa)-5 /E=in. DAB "C'%3

    "ormal Tes) (e?le6)in. )-e 6a(+i*0as6ula( ?un6)i*n @alsal#a ratio G1421 2eart rate (+.+) inter#al #ariation d%ring deep !reathing (!eat*min)

    /orderline

    a!normal

    1411.1420

    H1410

    G15

    11.1-

    H10

    Cmmediate response to 4 G140standing Tes) (e?le6)in. s5mpa)-e)i6 ?un6)i*n /lood press%re response to standing (mm2g) /lood press%re response s%stained handgrip (mm2g) H10

    1401. 1403

    H1400

    11.29

    G30

    G16

    11.15

    H10

    ?#al%ation o7 the res%lts >he res%lts were then categori0ed 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

    -4 )om!ined parasympathetic and sympathetic damage1 where in addition to a!normal parasympathetic res%lt1 7indings in one or !oth o7 the sympathetic tests are a!normal (grade C@)4 >hese grading can !e categori0ed into three gro%p as (1) "ormal 7or grade C 1 (2) ?arly )'" 7or grade CC and (3) De7ined )'" 7or grade CCC and C@4

    4.C

    Da)a Anal5sis 't the end o7 the st%dy1 data was calc%lated with (P(( so7tware #ersion 1640 and

    analy0ed 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)-i6al 6*nsi+e(a)i*ns Cn7ormed consent was o!tained 7rom all patients4 ?thical clearance was re9%ested 7rom the M Med (c4 (Cnt4Med4) post grad%ate !oard o7 st%dies1 De7ence (er#ices Medical 'cademy4

    31

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