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Management of Diabetes Mellitus in Ramadan Fasting Month Pradana Soewondo Division of Endocrine and Metabolism, Department of Internal Medicine, Medical Faculty, University of Indonesia Surah Al-Baqarah: 183-184 • …..Observing As-Saum (the fasting) is prescribed for you as it was prescribed for those before you, …. • ….., but if any of you is ill or on a journey, …… And as for those who can fast with difficulty, (e.g. elderly, etc),……. PHYLOSOPHY OF FASTING • During Ramadan, Muslims must fast from dawn to sunset. • Food and fluids may be consumed freely during the night, but forbidden during day time, including oral and parenteral medication. • This will involve a sudden and major change in the daily meals. • This include meal timing, total calories, food type and consistency. • Prior to the month of Ramadan, people usually take 3 major meals (breakfast, lunch, dinner/supper) • This will change to only two meal named Iftar and Sahur. Iftar will be around 6:00 pm and Sahur will be around 3:00 am. Things Happened During Ramadan • Eating habits change in many ways, not only do mealtimes change, but patterns of meals, the short of food eaten and caloric intake all change in a stereotyped way. • Increased in post prandial physical activity during the nighttimes associated with Tarawih. • Psychological changes due to the general spiritual atmosphere during Ramadan, which create a feeling of inner well-being Physiological State of Healthy Individuals During Ramadan (Kuwait study) (1) • Body weight decrease transiently during the first half of Ramadan, but recovered by the end. • Respiratory and cardiovascular parameters during exercise were perturbed. • Plasma osmolarity and protein concentration were increased during Ramadan, maybe an indication of dehydration. Physiological State of Healthy Individuals During Ramadan (2) • Increases in acid and pepsin secretion were noted with no changes in plasma gastrin, mucogastrin, or the duodenogastric reflex. (Moroccan study) • Decrease in fasting plasma glucose and insulin. Increase in plasma proteins. Lipid parameters were not altered. (Tunisian study) Impact of Fasting in Diabetics During Ramadan • Blood glucose levels triggered homeostatic mechanism to prevent hypoglycemia. But in diabetics, this mechanism can be disrupted, and also perturbed by medication. • Risk of hypoglycemia during daytime and hyperglycemia following Iftar are 6 % and 3 % respectively. • Changes in timing medication are important. Impact of Fasting in Diabetics During Ramadan • If a proper medication regimen is followed, stable and uncomplicated patients on OHA should be able to fast without problems. • Patients taking single dose insulin or combination therapy may be able to fast but needs to be evaluated on an individual basis. Impact of Fasting in Diabetics During Ramadan • In the fasting state, individual depends totally on endogenous substrates for energy. • Fasting subject is considered in a state of catabolism since his source of energy are all decreasing. • The liver supplies glucose by glycogenolysis. Impact of Fasting in Diabetics During Ramadan • Glucose oxidation in liver and muscles is spared as soon as increased quantities of FFA becomes available. • A balance is reached at a plasma glucose level sufficient to ensure adequate brain function and at insulin and glucagon levels sufficient to prevent excessive depletion of previously stored nutrients. Effect on Diabetic Controlled During Ramadan Fasting • Observational study • N=60 (30 males and 30 females) • Well controlled type 2 diabetics treated with OHA (PPG < 200 mg%) • Mean body weight 0,75 Kg • Mean Post Prandial Glucose 9,32 mg% • No correlation from both parameters. Askandar T etal, Kopapdi V,1978. Effect of Ramadan Fasting on Well Controlled Diabetic Patients • Observational study • Well controlled diabetics with out severe complication • N=55; 49 on diet and 6 on diet +OHA • No Changes in BW, BG and lipid profile • There is no negative effects of fasting during Ramadan, as long as they followed the instructions. Manaf A. etal, Kopapdi V, 1981 Blood Glucose Responses Of Diabetics During the Fasting Month Ramadan • • • • Observational study N=22; controlled diabetic Diet and medication were maintain Blood glucose levels from 8 to 11 am at the first and last week of fasting month, but not from 11 am to 6 pm. • Hypoglycemia should be anticipated when good controlled diabetics are going to fast. Soegondo S etal, AOCE • Observational study • N=41 type 2 diabetics (9 on diet, 12 on single OHA, and 20 on combined OHA) • Number of symptomatic hypoglycemic periods, which were not biochemically verified, increased in eight of patients (19,5%) during Ramadan. None of the patients, however, experienced severe hypoglycemia or neuroglycopenic symptoms Ali Riza etal, Univ of Ankara In conclusion: • type 2 diabetic is not a contraindication to fasting in Ramadan • Patients on single or combination OHA could observe Ramadan fasting with appropriate instruction about meals and OHA use. • However some patients may still experience an increased number of hypoglycemic episodes Ali Riza etal, Univ of Ankara Treatment regimen and HbA1C level in 8 type 2 Diabetics, whose Hypoglycemic Events Were More Frequent During Ramadan Fasting Hypoglycemic events Patient number before during 1 2 3 4 5 6 7 8 1 1 1 1 1 1 1 1 Treatment regimen 2 4 4 3 3 9 3 8 AC=acarbose; MF=metformin Diet only Gliclazide Gliclazide Glybornuride Gliclazide, MF Glybori,MF Glyburi,MF,AC Glipizide, MF,AC HbA1c level (%) before after after 3 weeks 8 weeks 6.6 7.5 7.6 7.6 5.6 7.5 8.2 9.5 6.7 7.3 7.2 7.3 5.8 7.6 8.6 9.6 6.6 7.2 7.4 7.3 5.9 7.5 8.7 9.2 An Observational Survey of the Impact of Ramadan fasting on Diabetes • N=22; carried out in Malaysia. • No evidence of hypoglycemia was obtained. • Total caloric and carbohydrate intake both during Ramadan compared with Shaban, although the proportion of simple carbohydrate consumed from 8,4% to 14% • No changes in FBG or cholesterol level. • But fructosamine level from 6.6 to 4.3 mM. Mafauzy et al., 1990 Muslims with NIDDM Fasting During Ramadan: Treatment with Glibenclamide • Setting of study university hospital, private hospital, private clinic in Casablanca and Rabat, Morocco • n = 591 diabetic patients (198 men, 391 women and two unspecified) with similar duration of illness, length and amount of glibenclamide treatment. • To compare the efficacy of two glibenclamide regimen in NIDDM who were fasting and regular dose in non fasting group. Belkhadir et al., 1993 • Non randomized non fasting control group >< two groups of patients who fasted randomized equally two one of two regimen • Take their usual morning dose of glibenclamide in the evening and their usual evening dose before dawn; or to follow this pattern but to reduce the total dose by a quarter. Characteristics of Patients on Admission to Study, Value are Means (standard deviations) unless Stated Otherwise Groups of patients* Full dose Reduced dose Control of glibenclamideof glibenclamide (n = 199) (n = 198) (n = 194) p Value 56 No of men 137 No of women Age (years)† 57.2 (9.0) Weight (kg)‡ 64.9 (11.3) 2 Body mass index (kg/m ) ‡ 25.9 (3.9) Duration of diabetes (years)§ 8.53 (6.2) Usual daily dose of glibenclamide 11.7 (3.5) (mg)ll 383 (84) Serum concentration of fructosamine (mol)§ 14.2 (3.3) Glycated hemoglobin (%)§ 75 123 54.9 (9.3) 68.6 (10.3) 26.7 (3.8) 7.03 (5.5) 10.7 (3.1) 366 (85) 67 131 54.8 (9.7) 67.9 (11.4) 26.7 (4.2) 7.05 (5.35) 10.7 (3.5) 352 (82) NS 0.18 0.02 0.01 0.06 0.02 0.02 0.01 13.7 (3.4) 13.2 (3.6) 0.01 Data missing for † 10 cases, ‡ 4 cases, § 13 cases, and II 30 cases Characteristics of the 542 Who Completed the Study at The End of Ramadan. Figures are Means (standard deviations) Groups of patients* Full dose Reduced dose of of Control glibenclamide glibenclamide (n = 183) (n = 177) (n = 182) Fructosamine concentration (µmol/l): At start of Ramadan At end of Ramadan Glycated hemoglobin (%): At start of Ramadan At end of Ramadan Body weight (kg) At start of Ramadan At end of Ramadan 396 (91) 400 (102) 367 (80) 381 (96) 359 (82) 376 (98) 14.3 (3.6) 14.7 (3.2) 13.6 (3.5) 14.0 (2.9) 13.2 (3.6) 13.6 (3.2) 65.2 (11.4) 65.7 (11.4) 68.2 (10.0) 69.2 (10.0) 68.2 (82) 68.7 (10.8) Number of Hypoglycemia Events (number of affected patients) Reported During Study Groups of patients* During run in Control 16 (15) 11 (9) 8 (6) 35 (30) Full dose of glibenclamide 19 (13) 14 (10) 16 (12) 49 (35) Reduced dose of 18 (15) 10 (9) 8 (6) 36 (30) glibenclamide During During Ramadan follow up Total Result At the end of Ramadan there were no significant differences between the groups in fructosamine concentration, HbA1c and number of hypoglycemic event. Conclusion Glibenclamide is effective and safe for patients with non-insulin dependent diabetes who fast during Ramadan. The easiest regimen is taking the normal morning dose at sunset and any evening dose before dawn HYPOGLYCAEMIC EVENT AMONG TYPE 2 DIABETICS ON GLIMEPIRIDE AND OTHER SULFONILUREAS DURING RAMADHAN OBJECTIVE •To observe the occurrence of hypoglycaemic event on type 2 Diabetics on glimipiride and other sulfonilureas during fasting month •To describe the nutrition intake and metabolic changes on type 2 diabetic who were fasting during Ramadhan month METHOD •Hospital based, observational study, enrolliring controlled type 2 diabetics who want to fast Ramadhan •23 controlled type 2 diabetics who was treated with single dose sulfonilurea were enrolled Soewondo P et al. RSCM, Jakarta 1999. RESULTS 23 type 2 DM 2 drop out 21 completed the study 12 on glimepiride 9 other Sulfonilurea (glibenclamide, glicazide, gliquidone, glipizide) mg/dl Average Blood Glucose Level before dawn in Type 2 Diabetic Patients During Ramadan Fasting Month 138 134 130 126 122 118 114 110 106 102 98 94 90 132 128 125 126 126 119 111 105 I III II IV Week Glimepirid other Sulfonilurea Average Blood Glucose Level before break In Type 2 Diabetic Patients During Ramadan Fasting Month 110 106 104 105 104 mg/dl 100 100 98 100 96 96 95 90 I II III Week IV Glimepirid Other Sulfonilurea Average Energy Intake in Type 2 Diabetic patients during Ramadan Fasting Month 1700,00 1600,00 Energy(cal) 1500,00 1400,00 1300,00 1200,00 1100,00 1000,00 1 2 3 Visit 4 5 6 Subject Characteristics Victim Group Glimepiride (n=12) Other Sulfonilureas (n=9) P Men 2 4 Women 10 5 0.331 Old (year) 49.8 (+ 13.4) 58.1 (+ 8.4) 0.121 Lama DM (month) 33.9 (+ 34.2) 74.2 (+ 45.0) 0.048 Fasting Glucose (mg/dl) 124.0 (+ 30.7) 129.8 (+ 21.9) 0.637 Post Prandial 185.8 (+ 68.9) 183.0 (+ 45.4) 0.644 HbA1c (%) 7.4 (+1.3) 7.8 (+1.3) 0.470 IMT (kg/m2) 23.3 23.6 Dose (mg) 2.6 (+1.3) Glibenklamid 4 (+1.4) Gliklazide 80 Glipisid 5 Glikuidon 22.5 (+ 10.6) Body Mass Index and HbA1c Level in Type 2 Diabetic Patient Before and After Ramadan Fasting Month Group Glimepiride Other Sulfonilurea BMI (kg/m2) Before After HbA1c (%) Before After 23.3 23.2 23.6 23.2 7.4 (+1.3) 7.2 (+1.2) 7.8 (+1.3) 7.3 (+1.7) Lipid profile and kidney function in Type 2 Diabetic Patient Before and After Ramadan Fasting Month Parameter \ Group Total cholesterol (mg/dl) Before After HDL Cholesterol (mg/dl) Before After LDL Cholesterol (mg/dl) Before After Triglycerida (mg/dl) Before After Ureum (mg/dl) Before After Creatinine (mg/dl) Before After Glimepiride Other Sulfonilurea 214 (+36) 218 (+38) 230 (+70) 225 (+53) 56 (+6) 56 (+6) 48 (+8) 51 (+8) 115 (+61) 133 (+37) 141 (+50) 141 (+46) 213 (+24) 146 (+45) 205 (+14) 166 (+49) 32 (+4) 52 (+66) 37 (+10) 41 (+24) 0.9 (+0.2) 0.8 (+0.2) 1.1 (+0.5) 1.3 (+1.1) CONCLUSION There was no hypoglycemic event were reported in both groups in this study Changes in caloric and nutrient intake were noted and should be considered for diet consultation as well as treatment adjustment Recommendations on The Management of Diabetes During Ramadan • Put forward at a Consensus Meeting held in Casablanca, Morocco in 1995 • These covered: – criteria allowing for or exempting from fasting and recommendations for monitoring. – Other topic covered included community education programmers, treatment regimens – methodology and content for the future research programs CURRENT RECOMENDATIONS • Permitted to fasting : NIDDM patients treated with biguanides or sulphonyureas, who are stable and do not have any complicating progressive co morbid pathology. • Exempted from fasting : IDDM, unstable disease, co-morbid degenerative disease, pregnancy, elderly. CURRENT RECOMENDATIONS • Monitoring was recommended before, during and after Ramadan, include diabetic symptoms and glucose control, psychological state and co morbidity. • Education programs directed at patients and their families. should focus on condition in which fasting is contraindicated, modifying the regimen, dietary considerations, and the importance of monitoring. HOW TO IMPROVE THE MANAGEMENT 1. Guidelines The existence of clear guidelines on the management of diabetes during Ramadan are indispensable in ensuring safe and rewarding fasting in patients treated in primary care away from specialist clinic. 2. Education Programs 3. Research Contraindications • • • • Four contraindications in which patient should be exempted from fasting : Patients treated with insulin (NIDDM or IDDM) Brittle and decompensated diabetes (history of episodes of DKA or NKHO) Pregnancy Patients with potentially life-threatening acute complications Lifestyle • Ramadan provides and excellent opportunity to initiate healthy lifestyle changes. • Motivation for self improvement is high at this time of year, the switch in eating pattern breaks previous habits, and weight lose goals • Meals time should be fixed, with the principal meal in the evening, and the lesser meal before sunrise. Lifestyle • Patient should be encouraged to eat a proper. • Eating snacks between two meals should be avoided • Ensure that an appropriate level of physical activity is maintained, whether formal exercise programs or associated with fulfilling religious obligations. MEDICATION • In principle, any efficacious medication upon which patients is stabilized can be used during Ramadan. • An abrupt change in the nature of medication given should be avoided. • Medications regimen during Ramadan need to be modified in timing and possibly dose, and should be tailored for each individual patient. Monitoring • Important to be done to ensure adequate blood sugar control in spite of changes in eating habits and treatment protocols.