J Pediatr Endocrinol Metab 2016; aop
Amany El-Hawary, Nanees Salem*, Ashraf Elsharkawy, Abdelhameed Metwali, Alaa Wafa, Nehad Chalaby, Abelhady El-Gilany, Megahed Abo-Elmagd and Magdy El-Ziny
Safety and metabolic impact of Ramadan fasting in children and adolescents with type 1 diabetes DOI 10.1515/jpem-2015-0263 Received July 1, 2015; accepted January 4, 2016
Abstract Background: Annually, many children and adolescents with type 1 diabetes mellitus (T1DM) insist on fasting for Ramadan despite being exempted and despite knowing all the risks. We aimed to assess the safety and metabolic impact of Ramadan fasting in children with T1DM using different insulin regimens. Methods: Children with T1DM who choose to fast during Ramadan 1434/2013 (29 days) were recruited 3 months before Ramadan. They received pre-Ramadan intensive education. Three insulin regimens were included; Regimen-I (regular insulin/NPH); Regimen-II (regular insulin/insulin glargine) and Regimen-III (premixed insulin). Changes in weight, insulin dose, HbA1c, fructos amine and lipid profile were evaluated. Results: Out of total 53 patients (24 male), 28 patients (52.8%) completed Ramadan fasting (fasting group). The remaining 25 patients were included in (broke- fasting group). Positive correlation between fructosamine changes and number of days fasted during Ramadan. Significant decrease in post-Ramadan fructosamine ( 10% were excluded. Moreover, patients who had diabetes-related microvascular complications including; diabetic nephropathy, retinopathy or neuropathy based on the global consensus report published by the International S ociety for Pediatric and Adolescent Diabetes (ISPAD) and International Diabetes Foundation (IDF) were excluded [9]. In addition, those who had prehypertension, Stage 1, or Stage 2 hypertension according to the guidelines of National High Blood Pressure Education Program Working Group on High Blood Pressure in Children and Adolescents [10] were also excluded. Out of total of 115 diabetic patients who accepted to take part in our study, only 53 patients fulfilled the inclusion criteria.
Pre-Ramadan education program Patients and their families were informed about the legitimacy of abstaining from fasting and risks associated with fasting in diabetic patients. Patients with their families received a pre-Ramadan wellstructured intensive education program and written instructions were provided including; BGM frequency, insulin dose adjustment, dietary plane and activity changes. Informed consent was obtained from the parents of diabetic patients. The study protocol was approved by the Ethics Committee of Faculty of Medicine-Mansoura University, Egypt. Patients were asked to monitor blood glucose at pre-Iftar, pre-Sohur, 12-pm, 12-am and at any time they experienced signs/ symptoms of hypoglycemia. In view of the long fasting period (14– 15 h), patients were instructed to consume complex carbohydrates at Sohur as late as possible, consume simple carbohydrates with fibers at Iftar without delay and avoid skipping meals and night time gorging. Water intake was encouraged during non-fasting hours. Caffeine-based drinks (tea, cola) should be avoided because of the diuretic effect of caffeine. Normal level of activity is accepted and excess exercise should be avoided in pre-Iftar hours at which the risk of hypoglycemia is maximal. If Tarawih prayer is performed, it should be included in the patient’s daily exercise program. Patients were instructed to break fasting immediately if (1) blood glucose 300 mg/dL (16.7 mmol/L) [2, 12]. Severe hypoglycemia is considered if child has “altered mental status and cannot assist in their care and may require parenteral therapy (glucagon/or glucose)” [13].
Insulin therapy adjustment All patients were maintained on multiple daily insulin injections (MDIs) before Ramadan. Insulin regimens were altered during Ramadan to accommodate the change in meal time as the following; the pre-Ramadan lunch dose of regular insulin (RI) or breakfast dose of 70/30 pre-mixed insulin (PMI) was given before Iftar and the pre-Ramadan dinner dose of RI or PMI was given before Sohur. Pre-Ramadan basal dose of intermediate acting insulin (NPH) was given just after Iftar or insulin glargine (IG) was given at 12 am. It is important to clarify that this is not a study in which specific adjustment of the pre-Ramadan insulin dose are being examined but patients performed regular self-BGM and adjusted their dose accordingly. All patients received weekly follow-up at Diabetes Clinic, in addition to the 24-h hotline service whenever necessary.
Outcome measures Included number of hypo-, hyper-glycemic or DKA episodes, changes in weight, insulin dose. Blood samples were collected 1 day prior to Ramadan and on the 28th–29th of Ramadan after 12-h overnight fast for evaluation of fructosamine [14], lipid profile including; total cholesterol (TC), triglycerides (TG), low density lipoprotein (LDL) and high density lipoprotein (HDL) [15], and glycated hemoglobin (HbA1c%). Lipid profile including; TC, TG and HDL were determined by
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El-Hawary et al.: Ramadan fasting and type 1 diabetes 3
enzymatic colorimetric assay using Hitachi 704 Analyzer (Roche Diagnostics, Indianapolis, IN, USA) and LDL was calculated according to the Friedewald equation: “LDL =TC–HDL–TG/5”. Quantitative determination of fructosamine was based on colorimetric with reduction of nitroblue tetrazolium (NBT) reagent and the change in absorbance is measured at 520 nm (Chronolab System, Barcelona, Spain). HbA1c was measured by quantitative colorimetric ion exchange chromatographic determination of glycohemoglobin in whole blood assay kit, manufactured by Stanbio Laboratory (Boerne, TX, USA). Calibrators referenced to National Glycohemoglobin Standardization Program (NGSP) and HbA1c values were reported using the unit of percent (%).
Statistical analysis The SPSS software for Windows (version 16.0) (SPSS Inc., Chicago, IL, USA) was used for data analyses. Qualitative variables were presented as numbers and percentage (n%) and χ2-test was used for comparison between groups. Quantitative variables were presented as mean±SD. Repeated Measure Design ANOVA was used for the comparison between insulin regimen groups and between fasting and non-fasting groups in addition to the comparison between preand post-Ramadan values within all groups. p-Values
Amany El-Hawary, Nanees Salem*, Ashraf Elsharkawy, Abdelhameed Metwali, Alaa Wafa, Nehad Chalaby, Abelhady El-Gilany, Megahed Abo-Elmagd and Magdy El-Ziny
Safety and metabolic impact of Ramadan fasting in children and adolescents with type 1 diabetes DOI 10.1515/jpem-2015-0263 Received July 1, 2015; accepted January 4, 2016
Abstract Background: Annually, many children and adolescents with type 1 diabetes mellitus (T1DM) insist on fasting for Ramadan despite being exempted and despite knowing all the risks. We aimed to assess the safety and metabolic impact of Ramadan fasting in children with T1DM using different insulin regimens. Methods: Children with T1DM who choose to fast during Ramadan 1434/2013 (29 days) were recruited 3 months before Ramadan. They received pre-Ramadan intensive education. Three insulin regimens were included; Regimen-I (regular insulin/NPH); Regimen-II (regular insulin/insulin glargine) and Regimen-III (premixed insulin). Changes in weight, insulin dose, HbA1c, fructos amine and lipid profile were evaluated. Results: Out of total 53 patients (24 male), 28 patients (52.8%) completed Ramadan fasting (fasting group). The remaining 25 patients were included in (broke- fasting group). Positive correlation between fructosamine changes and number of days fasted during Ramadan. Significant decrease in post-Ramadan fructosamine ( 10% were excluded. Moreover, patients who had diabetes-related microvascular complications including; diabetic nephropathy, retinopathy or neuropathy based on the global consensus report published by the International S ociety for Pediatric and Adolescent Diabetes (ISPAD) and International Diabetes Foundation (IDF) were excluded [9]. In addition, those who had prehypertension, Stage 1, or Stage 2 hypertension according to the guidelines of National High Blood Pressure Education Program Working Group on High Blood Pressure in Children and Adolescents [10] were also excluded. Out of total of 115 diabetic patients who accepted to take part in our study, only 53 patients fulfilled the inclusion criteria.
Pre-Ramadan education program Patients and their families were informed about the legitimacy of abstaining from fasting and risks associated with fasting in diabetic patients. Patients with their families received a pre-Ramadan wellstructured intensive education program and written instructions were provided including; BGM frequency, insulin dose adjustment, dietary plane and activity changes. Informed consent was obtained from the parents of diabetic patients. The study protocol was approved by the Ethics Committee of Faculty of Medicine-Mansoura University, Egypt. Patients were asked to monitor blood glucose at pre-Iftar, pre-Sohur, 12-pm, 12-am and at any time they experienced signs/ symptoms of hypoglycemia. In view of the long fasting period (14– 15 h), patients were instructed to consume complex carbohydrates at Sohur as late as possible, consume simple carbohydrates with fibers at Iftar without delay and avoid skipping meals and night time gorging. Water intake was encouraged during non-fasting hours. Caffeine-based drinks (tea, cola) should be avoided because of the diuretic effect of caffeine. Normal level of activity is accepted and excess exercise should be avoided in pre-Iftar hours at which the risk of hypoglycemia is maximal. If Tarawih prayer is performed, it should be included in the patient’s daily exercise program. Patients were instructed to break fasting immediately if (1) blood glucose 300 mg/dL (16.7 mmol/L) [2, 12]. Severe hypoglycemia is considered if child has “altered mental status and cannot assist in their care and may require parenteral therapy (glucagon/or glucose)” [13].
Insulin therapy adjustment All patients were maintained on multiple daily insulin injections (MDIs) before Ramadan. Insulin regimens were altered during Ramadan to accommodate the change in meal time as the following; the pre-Ramadan lunch dose of regular insulin (RI) or breakfast dose of 70/30 pre-mixed insulin (PMI) was given before Iftar and the pre-Ramadan dinner dose of RI or PMI was given before Sohur. Pre-Ramadan basal dose of intermediate acting insulin (NPH) was given just after Iftar or insulin glargine (IG) was given at 12 am. It is important to clarify that this is not a study in which specific adjustment of the pre-Ramadan insulin dose are being examined but patients performed regular self-BGM and adjusted their dose accordingly. All patients received weekly follow-up at Diabetes Clinic, in addition to the 24-h hotline service whenever necessary.
Outcome measures Included number of hypo-, hyper-glycemic or DKA episodes, changes in weight, insulin dose. Blood samples were collected 1 day prior to Ramadan and on the 28th–29th of Ramadan after 12-h overnight fast for evaluation of fructosamine [14], lipid profile including; total cholesterol (TC), triglycerides (TG), low density lipoprotein (LDL) and high density lipoprotein (HDL) [15], and glycated hemoglobin (HbA1c%). Lipid profile including; TC, TG and HDL were determined by
Brought to you by | Emory University Authenticated Download Date | 3/4/16 11:11 AM
El-Hawary et al.: Ramadan fasting and type 1 diabetes 3
enzymatic colorimetric assay using Hitachi 704 Analyzer (Roche Diagnostics, Indianapolis, IN, USA) and LDL was calculated according to the Friedewald equation: “LDL =TC–HDL–TG/5”. Quantitative determination of fructosamine was based on colorimetric with reduction of nitroblue tetrazolium (NBT) reagent and the change in absorbance is measured at 520 nm (Chronolab System, Barcelona, Spain). HbA1c was measured by quantitative colorimetric ion exchange chromatographic determination of glycohemoglobin in whole blood assay kit, manufactured by Stanbio Laboratory (Boerne, TX, USA). Calibrators referenced to National Glycohemoglobin Standardization Program (NGSP) and HbA1c values were reported using the unit of percent (%).
Statistical analysis The SPSS software for Windows (version 16.0) (SPSS Inc., Chicago, IL, USA) was used for data analyses. Qualitative variables were presented as numbers and percentage (n%) and χ2-test was used for comparison between groups. Quantitative variables were presented as mean±SD. Repeated Measure Design ANOVA was used for the comparison between insulin regimen groups and between fasting and non-fasting groups in addition to the comparison between preand post-Ramadan values within all groups. p-Values
