The Effect Of Non-Caloric Restricted, Low-Carbohydrate Diet In .

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CentralJournal of Endocrinology, Diabetes & ObesityResearch ArticleThe effect of Non-CaloricRestricted, Low-CarbohydrateDiet in Reversing Type 2 DiabetesMellitus among Active OmaniDiabetic Patients Attending NorthMawaleh Health Center*Corresponding authorSalma Alkalbani, North Mawaleh Health Center,Muscat, Oman, Email: s alkalbani@yahoo.comSubmitted: 05 February 2020Accepted: 22 February 2020Published: 25 February 2020ISSN: 2333-6692Copyright 2020 Alkalbani SOPEN ACCESSKeywords Low carbohydrate dietGglycated HemoglobinSalma Alkalbani*North Mawaleh Health Center, Muscat, OmanAbstractBackground: There is growing evidence that low-carbohydrate diet can positively improve glycemic index in patient with type 2 diabetes mellitus in compare with currentlyrecommended method of low fat, high carbohydrate diet for the same group. However, more researches are needed to prove the effectiveness and safety of this type of diet beforestarting to implement it to diabetic patients.Objective: This study focused on the effectiveness of non-caloric restricted, low-carbohydrate diet in improving glycemic control over 24-week period in active Omani diabeticpatients attending primary care setting at North Mawaleh health center in Muscat Government.Research design and method: This is prospective descriptive study with longitudinal follow up and pre-test, post- test comparison. Eighty-three patients were recruited. Bloodcollected at baseline, at 12-week and 24-week. Each patient was advised to follow non-caloric restricted low-carbohydrate regimen ( 80 gm of carbohydrate per day) andexercise recommendations. The patients were seen every alternate week in the first month then monthly to look for reflow measurements, counselling and medication adjustment. Theprimary outcome was glycated hemoglobin (HbA1c).Result: Seventy-one patients were able to complete the study. Non-restrictive low-carbohydrate diet ( 80 gm of carbohydrate/day) showed marked reduction in glycatedhemoglobin in 24-week period by 11.58%, from 7.12 (SD1.067) % at week 0 to 6.28(SD1.066) % at week 24, p value 0.05. This reduction was noticed along with adjustment ofdiabetic medications. Additionally, the percentage of patients with optimal level of HbA1c ( 7%) was improved from 58 % of total patients studied to 79 % by the end of the study.There was significant mean weight reduction by 7.33 % from 82.63(SD14.3) kg to 76.67(SD14.90) kg (p value 0.05). High density lipoprotein increased from 1.30(SD0.297) to1.40(SD0.468) mmol/l, p value 0.05 and TAG was reduced from 1.47(0.934) to 1.22(0.564) mmol/l value 0.05. The mean eGFR was declined from 86.73 (SD6.21) to 84.92(SD8.47) ml/minper1.73m2 at the end of the study (p value 0.05). Diabetic medications were stopped in 18 (25.4%) patients, reduced in 7(9.8%) patients, increased in patients2(2.8%), and unchanged in 44(62.0%) patients. The linear regression failed to show any correlation between reduction in HbA1c and weight changes.Conclusion: Non-caloric restricted LCD improved glycemic control in patient with type 2 DM. It also improved lipid profile, BMI and medication requirements. However, itdemonstrated adverse effect on eGFR in patient with normal eGFR. Further controlled studies are warranted.INTRODUCTIONLow fat, high carbohydrate diet is the recommended dietarymethod in patient with type 2 diabetes mellitus. However, thistype of diet has higher proportion of carbohydrate that can raisethe postprandial serum glucose and subsequently increase insulinrequirement. Furthermore, low-fat diet was linked to increasein the risk of developing cardiovascular diseases. In recentyears, there was growing evidences that low-carbohydrate diet(LCD) can lead to improvement in glycemic index and reducedweight at short term. However, few well controlled studieshave comprehensively examined its long-term effectiveness onglycemic control and cardiovascular disease (CVD).Low carbohydrate dietLow-carbohydrate diet is basically restricted caloricintake by reducing the consumption of carbohydrates to 20to 60 gm per day (typically less than 20 percent of the dailycaloric intake) as per American academy of Family Physician[1]. However, there is no widely accepted definition of whatprecisely constitutes a low-carbohydrate diet. It is important tonote that the level of carbohydrate consumption defined as lowcarbohydrate by medical researchers may be different from thelevel of carbohydrate defined by dietitian. On the other hand,the consumption of protein and fat is increased to compensatefor part of the calories that formerly came from carbohydrates.The Glycemic Index (GI) is a relative ranking of carbohydrateson a scale from 0 to 100 according to the extent to which theyraise blood glucose levels after eating. Carbohydrates with a lowGI value (55 or less) are more slowly digested, absorbed andmetabolized and cause a lower and slower raise in blood glucoseand, therefore insulin levels [1]. On the other hand, foods withCite this article: Alkalbani S (2020) The effect of Non-Caloric Restricted, Low-Carbohydrate Diet in Reversing Type 2 Diabetes Mellitus among Active OmaniDiabetic Patients Attending North Mawaleh Health Center. J Endocrinol Diabetes Obes 8(1): 1121.

Alkalbani S (2020)a high GI are those which are rapidly digested, absorbed andmetabolized and result in marked fluctuations in blood glucoselevels. Thus, Low GI-carbohydrates are considered one of thesecrets to long-term health, reducing risk of type 2 diabetesand heart disease. It is also one of the keys to maintainingweight loss. Thus, patients following low-carbohydrate diethave advantage of reducing glycemic index and subsequentlyimprove blood glucose level. It is important to mention thatketosis readily occurs at carbohydrate intakes below 50 gm/day which demonstrate that the body’s glycogen supplies havebeen consumed and that protein and fat are being used as fuel. Inaddition, very low carbohydrate, ketogenic diets (VLCKD) appearto have more pronounced effects than other, less restrictedcarbohydrate diets in controlling glycemic level. Furthermore,low-carbohydrate diets initially induce significant water diuresisdue to glycogenolysis from increased protein consumption. Thus,a portion of the early weight loss in these diets is water weight.In one study, where they compared different dietaryapproaches for the management of type 2 diabetes mellitus, theyfound that low carbohydrate diet (LCD) is effective in improvingvarious markers of cardiovascular risk in people with type 2 DM[2,3]. Another study compared the effectiveness and safety ofLCD (130 gm/day) with calorie restricted diet (CRD) in reducingHbA1c and BMI in Japanese patients with poorly controlledT2DM and it demonstrated significant outcome in LCD comparedto the CRD [4]. Furthermore, A study showed low-carbohydrateketogenic diet ( 20 gm carbohydrate / day) decreased HbA1cfrom 7.5 ( /- 1.4) % to 6.1 ( /- 1), p 0.001, along with reductionand/or discontinuation of diabetic medication [5]. Another studycompared the effect of low-carbohydrate, ketogenic diet versuslow glycemic index diet on glycemic control in type 2 DM revealedthat low carbohydrate diet had greater improvement in glycemiccontrol, more frequent medication adjustment and eliminationthan low glycemic index diet [6]. However, the effect on renalfunction (creatinine clearance and eGFR were insignificant inseveral studies [5,7,8].METHODOLOGYParticipantsTotal of 83-participant were recruited which representsthe active patients with type 2 diabetic mellitus who attendeddiabetic clinic at North Mawaleh health center (NMHC) fromJanuary 2017 to December 2018 and have met the inclusion andexclusion criteria. The inclusion criteria were: active diabeticpatients aged 20-60 year who are registered in NMHC diabeticregistry, diagnosis of type 2 DM made within last 8 years, diabeticpatient on oral hypoglycemic agent, diabetic patient with no h/odiabetic ketoacidosis or end organ damage, diabetic patient withbody mass index (BMI) more than or equal to 25 kg/m2 and norecent change in diabetic medication for the last three-month.The exclusion criteria were: diabetic patient on insulin therapy,previous history of diabetic ketoacidosis or end organ damage,chronic kidney disease stage 3 and less (eGFR 60 ml/min per1·73m2 , active liver diseases or CVD, pregnant ladies with type2 DM, or breastfeeding ladies with type 2 DM , and patient whofail to adhere to non-caloric restricted low-carbohydrate diet. Allpotential patients were called for office interview where theyJ Endocrinol Diabetes Obes 8(1): 1121 (2020)got a brief explanation and time frame of the study. Informedconsent was taken for each participant before being recruited inthe study. The patient had all the right to withdraw from studyany time he/she wants.Study designThis is prospective descriptive study with longitudinal followup and pre-test post-test comparison undertaken in the outpatientclinic of North Mawaleh health center in Muscat Governmentover 24-week period from 01/01/2019 to 30/06/2019.Ethicalapproval was obtained from scientific research committee atministry of health. All enrolled patients had signed consent formprior to entry to the study.Sample sizeTotal of 83 participants were recruited. This numberrepresents all active patients with type 2 diabetic mellitus whoattend diabetic clinic since January 2017 till June 2018 and metthe inclusion and exclusion criteria. The active patient with type2 DM were defined as those who attend diabetic clinic at least2 times per year and found to be 482 out of 1007 registered inthe health center (taking in to consideration that this numberrepresent total patient since the start of registration in 2010, butsome of them were transferred, died or not regular follow up).Out of this number only 93 of those were fully met the inclusionand exclusion criteria and out of this number 83 signed theconsent form to start on this study.InterventionAfter meeting the selecting criteria of the study, a baselinehistory, physical examinations and laboratory investigations(LFT, RFT, Lipid profile, Hb A1c, Albumin creatinine ratio,TSH, uric acid, ACR, FBS) were collected before the start of thestudy. Then, all participants were given detailed informationabout non-caloric restricted low-carbohydrate diet ( 80 gm ofcarbohydrate/day) by dietitian as individual or in small groupsessions at first encounter. Along with proposed diet, patientswere allowed unlimited amount of animal food and eggs,unlimited amount of unsaturated fatty acid, restricted amountof saturated fatty acid. Furthermore, they were provided withleaflet of proposed diet to follow-up through 24-week period. Thepatients were advised to keep diary of their diet and to submitit in each visit. In addition, everyone was instructed to followup exercise recommendation of at least 30 minutes of moderateintensity exercise for at least five times per week, but no formalexercise program was proposed.The patients were followed every other week in the firstmonth then monthly thereafter for anthropometric measurement(weight and BMI, waist circumference), vital signs measurement(BP, FBS), adherence to diet and exercise advice and medicationsadjustment. To maximize adherence to study visits, participantswere provided with an appointment schedule and receivedappointment reminders (phone calls or text messages) beforevisits. Weight was measured by using electronic scale. Waistcircumference was also measured by using measurement tappositioned 3 cm above iliac crest. Reflow measurement, usingpersonal glucometer devices that were well calipered, was doneevery alternate day in order to plan for any adjustment in oral2/7

Alkalbani S (2020)hypoglycemic medications (OHA). Medications (including thedosage and frequency) at baseline and change throughout thestudy period were documented. In each visit, participants wereadvised to present their diary of diet and exercise to check theiradherence to proposed regimen. Additionally, direct questioningabout hypoglycemic symptoms, craving for carbohydrate andother possible side effect were done at each visit. Those who failto adhere to dietary regimen were excluded from the study. Thelaboratory investigations were done at 3 stages, baseline, 12week and 24-week.OutcomePrimary outcome: The primary outcome was HbA1c. Itrepresents the control of blood glucose level over previous3-month and thus it is an excellent predictor of primary outcome.It was measured at baseline, 12-week and 24-week by usingimmunoassay technique.Secondary outcome: The secondary outcomes were lipidprofile (TC, LDL, HDL, TAG), eGFR, weight changes and medicationadjustment. The laboratory investigations were collected in themorning after fasting for at least 8 hours and processed at samelaboratory center to ensure standardization of the results. Fulllaboratory investigations were done before the start of the study,at 12-week and 24-week. Moreover, weight was also checkedat each encounter using calipered scale. Additionally, diabeticmedications adjustment was also documented at each visit basedon reflow measurement, adverse effect and diet and exercisecompliance were also documented. Adherence to proposeddietary regimen was also assessed at each encounter and thosewho fail to adhere to it were excluded from the study. The fullhistory, physical examination and laboratory investigations weretaken at the end of 24-week period. Changes in all variables wereanalyzed by the paired t-test. Linear regression analysis was usedto examine predictors of change in hemoglobin A1c. A p value of0.05 or less was considered statistically significant.Funding sourceThe researcher has conducted the study independent ofany funding source. There was no rule for funding source inconducting the study.RESULTStudy participantEighty-three participants had been recruited in this study,out of which 71 completed the full 24 weeks period of the studywith 14 % discontinuation rate. The reasons for discontinuationwere: 5 had difficulty to adhere to diet regimen and 7 wereunable to attend the proposed meeting schedules due to othercommitments. However, No one has reported that diet sideeffect as the main reason for discontinuation of diet regimen.The female participants accounted for 66.2 % (n 47) of totalparticipants while the male participant accounted for 33.8% (n 24). The baseline characteristic of the study is shown in the Table1 below.Dietary adherence and physical activity complianceAll candidates were given written prescription of dietaryJ Endocrinol Diabetes Obes 8(1): 1121 (2020)Table 1: Baseline characteristic (n 71).CharacteristicsummaryAge, years, mean (SD)48.0(6.76)Gender, female, n (%)47(66.2%)Weight, kg, mean (SD)82.63(14.3)BMI, kg/m , mean (SD)31.28(5.49)Height, m, mean (SD)21.6(0.84)regimen (low carbohydrate diet of 80 gm/day) and physicalactivity advice to follow throughout the period of study. Thepatients were advised to keep diary of daily intakes and physicalactivities and present it in each visit to ensure their adherence todiet regimen. Patients who fail to adhere to dietary regimen wereexcluded from the study. Total of 12 (14.5%) patients droppedout of the study and of which 5 (41.6%) patients had difficulty toadhere to diet regimen.Anthropometric measurementThe mean body weight had shown significant reductionby7.33 % from 82.63(SD14.3) kg at week 0 to 76, 67 (SD14.9)kg at the end of the study (p value 0.05) (Table 1-4). Thus, thenet reduction of body weight at 24-week was – 5.96 kg. The waistcircumference had also demonstrated significant reduction from105.5 (SD11.16) cm at 0-week to 101.01(SD11.129) cm at 24week (p value 0.05).The change in BMI at baseline and at 24 weeks was alsonoticed. At baseline, the distribution of patients as per their BMIwere as following: 0% with normal weight( BMI 18-24.9 kg/m2 ), 34 % with overweight( BMI 25-29.9 % kg/m2 ), 32 % withobesity class I (BMI 30-34.9 kg/m2 ), 25 % with obesity class II(BMI 35-39.9 kg/m2 ) and 8 % with obesity class III ( BMI 40 kg/m2 and above). There were more pronounced changes noticedin patients with class I ( from 32% at week 0 to 23 % at week24)and class 2 obesity (from 25 % at week 0 to 15 % at week24).However, obesity class III showed modest change 8 to 6%,(Figure 1, 2). On the other hand, 20 % of patient could reachnormal BMI by the end of the study. Moreover, percentage ofpatient with overweight increased from 34% at baseline to 37%at 24 weeks which could be explained by those patients who lostweight and moved from obesity category to overweight category.Glycated hemoglobin (Hb A1c)The mean HbA1c was measured at 3 periods: week 0, week12 and week 24. There was significant reduction in HbA1c by11.58% from 7.12 (SD1.067) at week 0 to 6.28 % (SD1.066) atweek 24 of the study, p value 0.05 (Table 4). The net change inHbA1c was -0.84%. This improvement of HbA1c was noticed whilemedications get reduced/discontinued in most of the patients.The level of control of HbA1c was also analyzed. The percentageof patients with controlled HbA1c ( 7%) was increaseddramatically from 58% at week 0 to 79% at week 24 and thisimprovement was noticed while the medications get adjusted.On the other hand, the percentage of patients with uncontrolledHb A1c ( 7%) was reduced from 42 % at the beginning of thestudy to 21% at the end of the study (Table 3, Figure 3). In linearregression analysis, there was no absolute correction betweenHbA1c, body weight and waist circumference.3/7

Alkalbani S (2020)Table 2: Anthropometric measurement.Week 0MeasurementMean (SD)82.63Weight(14.3)Waist circumference105.5(11.16)Week 12Mean (SD)Week 24Mean (SD)Mean changes(0-24 weeks)p-value(0-24 weeks)78.41(14.5)76.67(14.90)-5.96(-7.33%) 0.05102.3(11.16)101.01(11.129)-4.26%Table 3: The effect of non- caloric restricted low-carbohydrate diet on Glycated hemoglobin (HbA1c).HbA1cHbA1cHb1c %(0-week)(24-week) 7%41(58%)56(79%)7 to 9%23(32%)14(20%) 9%7(10%)1(1%)p-value(0 to24 week) 0.05Table 4: The effect of Non-caloric restricted low-carbohydrate diet on other metabolic measures.Week 0Week 12Mean (SD)Mean eightWCHba1cTCLDLHDLTAGEGFRACRUATSHOther metabolic .51)Change(0to 6 Month)Week 7)4.85(14.61)307.98(72.51)2.31(1.73) 0.05p-value(0 to 24week)%-7.33%-4.26%-11.58%2.24% 0.05 0.05 0.050.88%.740.5777.55% 0.05-2.1 % 0.0515.71% 0.05-16.96%.4283.12%.1821.64%.839GenderRegarding the other metabolic measurements, serumtriacylglyceride (TAG) showed mean reduction of 21.8% (from1.47 /- 0.934 at baseline to week to 1.22 /-564 at 24 weeks,p value 0.005. HDL-cholesterol showed steady increase from1.30 (SD0.297) to 1.40 (SD0.468), p value 0.05. However, theserum total cholesterol and LDL-cholesterol showed insignificantchanges throughout the study period (Table 4). EGFR had reducedsignificantly from 86.73 /- 6.21to 84.92 /-8.47at the end of thestudy (p value 0.05). No significant changes have been noticedin uric acid, urine ACR and TSH throughout period of the study.0%33.8%FemaleMale66.2%Medication adjustmentDiabetic medications adjustment was also studied. At baselineJ Endocrinol Diabetes Obes 8(1): 1121 (2020)Figure 1 Gender.4/7

Alkalbani S (2020)BMI changes pre and post .16%0.05018 to 24.925 to 29.930 to 34.9BMI Week035 to 39.940 and aboveBMI Week 24Figure 2 BMI changes pre- and post- study.Glycosylated hemoglobin( HbA1c)90%79%80%70%HbA1c 7HbA1c 7-9%58%60%HbA1c 9%50%40%32%30%20%20%10%10%[VALUE]0%Week 0Week 24Figure 3 The effect of non- caloric restricted low-carbohydrate diet on Glycosylated hemoglobin (HbA1c).Oral hypoglycemic Medications Adjustment70%62%medication pre study60%medication post 0%on 1 medicationFigure 4 Oral hypoglycemic Medications Adjustment.0n 2 medicationthere was 44(62%) patients on monotherapy, 25(35.2%) patientson dual therapy and 2(2.8%) patients were on triple OHA.Post study, there was 33(46.5 %) patients on monotherapy,17(23.9%) patient on dual therapy, 3 (4.2%) patients were ontriple therapy and 18(25.4 %) patients were able to quite all oralhypoglycemic medications (Figure 4, Table 5). Out of 44 patientswho were on monotherapy, 17 patients had discontinued theJ Endocrinol Diabetes Obes 8(1): 1121 (2020)0n 3 medicationNo medicationOral hypoglycemic medications, 26 had continued same dose ofOHA, and one patient shifted to dual therapy at end of the study(Table 5). On the other hand, out of 25 patients who were on dualtherapy, only one patient could quite his medication, 7 patientshad reduced their medications to one drug, 16 patients continuedsame dose and1 patient increased to three medications. None ofthe patient who was in triple oral hypoglycemic medications could5/7

Alkalbani S (2020)Table 5: Oral hypoglycemic medication adjustment.Medication adjustmentmedication prestudyTotal1 medication2medication3medicationNo medication17(23.90%)1(1.40%)0medication post studyon 1 medication 0n 2 4%)033(46.5%)manage to adjust their doses yet their HbA1c had improved over24-week period. Overall 25.4 % of the patient were able to quitethe medication, 9.9 % could able to decrease the dosage,2.8 %increased and 62 % continued same dose (Table 6). Throughoutthe study, the dyslipidemia and hypertension medications werenot adjusted.Adverse effectThe main side effect of this diet was headache accompaniedby constipation especially in the first week of the study. Fiftyfour percent of patients reported headache and 66 % reportedconstipation. However, the intensity of this side effect fades upwith continuation of the diet regimen. None of the participanthad symptoms of hypoglycemia or fatigability.DISCUSSIONThis is single arm 24-week intervention study which measuredthe effect of non-caloric restricted low-carbohydrate diet inreversing type 2 DM. Low carbohydrate diet showed significantimprovement in glycated hemoglobin, lipid profile, weight andwaist circumference and need for diabetic medications over24-week period. Additionally, this improvement was noticedwhile diabetic medications get adjusted. Eighteen participants(25%) have successfully managed to quite their medication andmajority of them were from monotherapy group. However, thisadjustment was done under medical supervision and startedas soon as 2 weeks after implementing diet program. Thus, it isrecommended that patients with type 2 diabetes mellitus shouldconsult their physician before starting this type of diet regimenas this might need further monitoring of blood sugar level andadjustment of diabetic medications. Overall, this study was ofshort period and thus the effect of this diet on long term manneryet to be further studied.Effect of LCD on glycemic controlThis study used HbA1c and FBS as indicators for glycemiccontrol. The net reduction in HbA1c was 11.58 % throughout 24week period, p value 0.05, and this reduction was observed whileTable 6: Summary of oral hypoglycemic medication adjustment.Row LabelsCount of Medication adjustmentIncreased2.8%Stopped25.4%DecreasedSameJ Endocrinol Diabetes Obes 8(1): 1121 (2020)9.9%62.0%017(23.9)0n 3 )22.8%)71diabetic medications get adjusted. The possible cause for thisimprovement was reduction in high glycemic index food and totalamount of food rich in carbohydrate without restricting caloriesintake. It is also shown that this diet contributes to improvementof HbA1c irrespective of weight changes. A study conducted byYamada et al and his colleagues showed that HbA1c levels weresignificantly decreased by 7.9% which was lesser than net changeachieved in HbA1c in our study [9]. Many other studies haveshown similar result comparable to our dietary regimen [1-3,10].Furthermore, the percentage of people with controlled glycatedhemoglobin (HbA1c 7%) had improved dramatically from 58 %at week 0 to 79 % at week 24weeks. This means that regardlessof medication adjustment this diet regimen showed tremendousimprovement in HbA1c despite the short duration of the study.Medications adjustmentIn previous researches, few studies mentioned in detail aboutmedication adjustment throughout study period [5,6]. Otherstudy also focused on adjustment/discontinuation of diureticmedication as LCD regimen might case additional diuresis [5].This study highlights the oral hypoglycemic medications usedbefore starting of the study and what changed have been madethrough the 24-week period without making any adjustment inother medication( including diuretics). Most of the medicationadjustment were occurred in the monotherapy group where17 patients have managed to discontinue treatment at the endof the study. However only one patient from dual therapy groupcould manage to discontinue his medication. None of the patientswho were on triple antidiabetic medication could manage toadjust their medication yet their HbA1c showed improvementthroughout the study. The possible reason for that is people ondual and triple oral hypoglycemic medications had HbA1c ofmore than 7 % which need careful monitoring of his/her bloodsugar level as well as HbA1c before attempting to reduce thedosage of medication. Additionally, it needs sustainability of dietregimen throughout longer period to get desired effect.wwWeight reductionThe mean reduction of weight in this study was 7 kg. Withcompare to other studies, the average reduction was even higherthan this study [6,5,11]. The main reason for this difference isthe amount of carbohydrate put in each regimen. The lower thecarbohydrate diet regimen, the more pronounce is the weightreduction. Other factors might contribute to this variation in netweight reduction are short period of the study, some patient ongliclazide that might adversely increase weight, adherence to6/7

Alkalbani S (2020)physical activity and presence of other comorbidity that interferewith their adherence to physical exercise.REFERENCESSimilar to previous studies, LCD showed increase in HDLcholesterol, reduction in TAG, but no significant changed wasnoticed in total cholesterol and LDL-cholesterol [5,6]. On theother hand, previous studies showed no significant effect ofLCD on renal function test [5-7]. However, this study showedsignificant reduction in eGFR over 24-week period (from 86.73 /6.21to 84.92 /-8.47, p value 0.05). No significant changes havebeen noticed in ACR. This change in eGFR might be due to higheramount of protein intake in this type of diet which can adverselyaffect kidney function over short term period. However, data arestill lacking regarding its effect over long term period. Thus, thistype of diet might not be a good option for patient with chronickidney disease (CKD) [12-14]. Further studies are needed toevaluate its effect on patients with normal renal function overlonger period.2. Ajala O, English P, Pinkney J. Systematic review and meta-analysis ofdifferent dietary approach to the management of type 2 diabetes. AmJ Clin Nutr. 2013; 97: 505-516.Other metabolic parametersLIMITATIONThe main limitation of this study was its smaller sample size.Other limitations were shorter duration of the study and lackof control group. Furthermore, there might be measurementdifferences that exist in FBG which were measured at home bythe patients themselves using different calipered glucometer.Finally, there was no upper limited sit for exercise the patientmight do in daily bases.CONCLUSIONNon-caloric restricted low- carbohydrate diet showedsignificant improvement on glycemic control, HDL- cholesterol,and TAG, weight and waist circumference despite the shortduration of the study. Additionally, there was significantimprovement in term of drug reduction/discontinuation.However, there is concern that this diet might adversely affectkidney function over short period of time which was not shownin previous studies. Its effect over long period of time is yet tobe studied. Further studies with control group are recommendedto address the effectiveness of this diet and compare it withconventional diet used for type 2 DM.AUTHOR CONTRIBUTIONSI would like to give my thanks and gratitude to Mrs. SumayaAmbosaidi, dietitian at North Mawaleh health center, for herexpert contribution in formulating non-caloric restricted lowcarbohydrate diet. I am also thankful and grateful for the patientsfor their participation in this study as well as SPSS data analysisgroup for their expert input in analyzing the data.1. Allen R. Last, Stephen A. WILSON Low-Carbohydrate Diets, Am FamPhysician. 2006 1; 73:1942-1948.3. Tay J, Luscombe-Marsh ND, Thompson CH, Noakes M, Buckley JD,Wittert GA, et al. Comparison of low- and high-carbohydrate diets fortype 2 diabetes management: a randomized trial. Am J Clin Nutr. 2015;102: 780-790.4. Sato J, Kanazawa A, Makita S, Hatae C, Komiya K, Shimizu T, et al. Arandomized controlled trial of 130g/day low-carbohydrate diet intype 2 diabetes with poor glycemic control. Clin Nutr. 2017; 36: 9921000.5. Yancy WS Jr, Foy M, Chalecki AM, Vernon MC, Westman EC. A lowcarbohydrate diet, ketogenic diet to treat type 2 diabetes. Nutr Metab(Lond). 2005; 2: 34.6. Westman EC, Yancy WS Jr, Mavropoulos JC, Marquart M, McDuffie JR.The effect of low-carbohydrate, ketogenic diet versus a low-glycemicindex diet on glycemic control in type 2 diabetes mellitus. Nutr Metab(Lond). 2008.7. Oyabu C, Hashimoto Y, Fukuda T, Tanaka M, Asano M, Yamazaki M, etal. Impact of low-carbohydrate diet on renal function: a meta-analysisof over 1000 individuals from nine randomized controlled trials. Br JNutr. 2016; 116; 632-638.8. Suyoto PST. Effect of

registry, diagnosis of type 2 DM made within last 8 years, diabetic patient on oral hypoglycemic agent, diabetic patient with no h/o diabetic ketoacidosis or end organ damage, diabetic patient with body mass index (BMI) more than or equal to 25 kg/m2 and no recent change in diabetic medication for the last three-month.

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