|Year : 2022 | Volume
| Issue : 1 | Page : 22-27
Effects of different regimens of insulin on body mass index commonly used in type 2 diabetes mellitus
Tazin Islam1, Adhir Kumar Das1, Md. Arifur Rahaman1, Sharifun Nahar2, Quazi Alifa Jahan3, M A Jalil Ansari4, Indrajit Prasad4, Mohammad Saifuddin4, Moinul Islam4, Mirza Sharifuzzaman4
1 Department of Pharmacology, Dhaka Medical College, Tangail, Bangladesh
2 Department of Pharmacology, Sheikh Hasina Medical College, Tangail, Bangladesh
3 Medical Officer, Square Hospital, Dhaka, Bangladesh
4 Department of Endocrinology, Dhaka Medical College, Bangladesh
|Date of Submission||30-May-2022|
|Date of Decision||04-Jul-2022|
|Date of Acceptance||19-Jul-2022|
|Date of Web Publication||26-Aug-2022|
Dr. Tazin Islam
Dhaka Medical College, Dhaka
Source of Support: None, Conflict of Interest: None
Background: Weight gain is an ongoing challenge when initiating insulin therapy in patients with Type 2 diabetes mellitus. The aim of this study is to observe and compare the effect of commonly used regimens of insulin on body mass index (BMI) among Type 2 diabetes patients. Methods: An observational study was conducted in two diabetic centers in Dhaka starting from July 2018 to June 2019. During the 12 weeks of the data collection period, a total of 100 patients were included according to selection criteria and then divided into two equal groups. Patients who were prescribed with premixed (conventional or analog) 30/70 insulin twice daily with or without oral Antidiabetic drugs were included in Group I (n = 50) and the patients who were prescribed with insulin glargine once daily with a bolus insulin (conventional or analog) three times before large meals with or without oral Antidiabetic drugs were included in Group II (n = 50). BMI was calculated from the height and weight of the patients initially as baseline data and again after 12 weeks of treatment in both groups. Fiber Bragg grating, 2 h ABF, and hemoglobin A1C (HbA1c) change were also observed among the patients of both insulin groups from diagnostic reports during the study period. Results: After 12 weeks of treatment, mean body weight (±standard deviation [SD]) was increased significantly from 59.82 ± 12.33 kg to 60.40 ± 13.38 kg in Group I (P = 0.01) and from 59.00 ± 12.36 kg to 60.33 ± 12.97 kg in Group II (P = 0.02). Mean BMI (±SD) increased significantly from 23.71 ± 4.69 kg/m2 to 24.10 ± 4.17 kg/m2 in Group I (P = 0.01) and from 24.00 ± 4.30 kg/m2 to 24.43 ± 4.59 kg/m2 in Group II (P = 0.02) during the study period. The mean BMI compared between two study groups (24.10 ± 4.17 vs. 24.43 ± 4.59) kg/m2 m+ after 12 weeks of treatment was not statistically significant (P = 0.816). About 64.0% of patients in Group I and 68.0% in Group II have shown weight gain and BMI change after 12 weeks. Mean HbA1c (±standard deviation [SD]) reduced significantly from 10.40% ± 2.17% to 7.76% ± 1.41% in Group I and from 10.41% ± 1.80% to 7.63% ± 1.37% in Group II. About 48.0% of patients in Group I and 56.0% of patients in Group II achieved glycemic target <7%. About 28.0% of patients in Group I and 20.0% of patients in Group II had hypoglycemia. Conclusion: From the current study, it can be concluded that both insulin regimens significantly cause weight gain, BMI change and also significantly effective in glycemic control. However, in comparison between the two groups, there was no significant difference. Hence, both premixed and glargine-based basal-bolus regimen can be prescribed as per patient need. This result may provide some preliminary information for further investigation
Keywords: Body mass index, comparison, insulin, insulin regimen, type 2 diabetes mellitus
|How to cite this article:|
Islam T, Das AK, Rahaman MA, Nahar S, Jahan QA, Ansari M A, Prasad I, Saifuddin M, Islam M, Sharifuzzaman M. Effects of different regimens of insulin on body mass index commonly used in type 2 diabetes mellitus. Bangladesh J Endocrinol Metab 2022;1:22-7
|How to cite this URL:|
Islam T, Das AK, Rahaman MA, Nahar S, Jahan QA, Ansari M A, Prasad I, Saifuddin M, Islam M, Sharifuzzaman M. Effects of different regimens of insulin on body mass index commonly used in type 2 diabetes mellitus. Bangladesh J Endocrinol Metab [serial online] 2022 [cited 2022 Sep 30];1:22-7. Available from: https://www.bjem.org/text.asp?2022/1/1/22/354775
| Introduction|| |
Diabetes mellitus is a complex metabolic disease that is associated with hyperglycemia occurring either from a deficiency in insulin secretion, insulin action, or both. This long-standing hyperglycemia in diabetes mellitus causes damage, dysfunction, and failure of different organs, especially the eye, kidney, nerve, heart, and blood vessels. The prevalence of diabetes mellitus is rising globally. It has been estimated that in 2017, there were 425 million people (aged 20–79 years) who had diabetes and by the year 2045, the number is expected to be 693 million. According to IDF 2017, the prevalence of diabetes in Bangladesh was 6.9%, but it is estimated at 8.5% and 10% by some studies. By the year 2030, Bangladesh is likely to be the 8th highest ranking country in term of the number of diabetes people. Approximately 4.0 million people died from diabetes worldwide in 2017, which was equivalent to one death in every 8 s. According to the World Health Organization diabetes will be the seventh-leading cause of death by the year 2030.
Diabetes is a major cost burden on health-care facilities in all countries. In 2017, the total health-care expenditure attributed to diabetes was estimated at United States dollar (USD) 727 billion, which was 8% more, compared to the health-care expenditure estimated in 2015. In Bangladesh, diabetes patients need two times more inpatient admission, 1.3 times more outpatient visits and 9.7 times more prescribed medicine annually compared to nondiabetes patients. Total health-care expenditure is around US$5.3 billion in Bangladesh. Based on total annual point-of-service payment, the health-care expenditure was estimated 6.12 times higher for diabetes patients compared to nondiabetes.
The aim of optimum glycemic control in Type 2 diabetes mellitus is to reduce the risk of long-term macrovascular and microvascular complications. Dietary and lifestyle modifications are the first approach to maintain optimal glycemic control (HbA1c [HbA1c] <7.0%, FBS 4.4–7.2 mmol/l, 2 h after meal <10 mmol/l), besides that many oral and injectable antidiabetic drugs are also used based on effectiveness, cost, risk of hypoglycemia, weight gain, and patient's preference. Insulin is the most effective antidiabetic medication. Early starting of insulin in Type 2 DM ensures superior glycemic control and improve the patient's quality of life, but it may cause weight gain and hypoglycemia as well. The fear of daily injection as well as weight gain and risk of hypoglycemia are the barriers for early initiation of insulin for the patients as well as for the physicians. According to the United Kingdom Prospective Diabetes Study, patients who are in intensive insulin therapy gained more weight in the shortest period, approximately 2–6 kg weight gain occurred during the period of 6–12 months. Insulin-mediated weight gain may be associated with high insulin dosage, especially needed for patients having higher HbA1c and lower BMI at the time of insulin initiation, and also may be related to insulin regimen. This insulin-induced weight gain may be related to dyslipidemia, hypertension, and adverse cardiovascular outcome.
Regarding the weight gaining effect of different insulin regimens, the lowest weight gain has occurred with basal insulin regimen than basal-bolus or premixed regimen and among basal insulins, the lowest weight gain was seen with insulin detemir than with NPH and highest with glargine. In comparison between basal-bolus and premixed insulin, Home et al. have shown that HbA1c, FBS, and 2 h ABF were significantly reduced in both study groups with significant weight gain occurring in both groups. This study may give an idea about the effects of commonly used insulin regimens on body mass index (BMI) and may help the physicians to select a suitable regimen at an appropriate time to the patients and correlate further complications.
| Methods|| |
This observational hospital-based study was carried out in the Endocrinology outpatient Department of Dhaka Medical College Hospital and the outpatient Department of Ibrahim General Hospital (National Healthcare Network) in Mirpur, Dhaka. Ethical clearance was taken from the ethical review committee of both Dhaka Medical College Hospital and Ibrahim General Hospital authority. These two hospitals in Dhaka were selected for convenience of communication and data collection. Patients were selected purposively from above-mentioned hospitals according to the inclusion and exclusion criteria then a signature in the informed written consent was obtained from the patients after a complete explanation of the procedure and purpose of the study.
Inclusion criteria were as follows:
- Diagnosed cases of Type 2 diabetes mellitus
- Patients prescribed with premixed 30/70 insulin (conventional or analog) and glargine-based basal-bolus (conventional or analog) regimen for the first time
- Patients who were willing to continue their insulin throughout the study period (12-week)
- Patients of both genders and ages (30–70) years.
Exclusion criteria were as follows:
- Patients on oral antidiabetic medication only
- Patients not willing to participate in the study
- Patients with acute illness.
About 135 patients were interviewed and their baseline height, weight, BMI, Fiber Bragg grating (FBG), blood glucose 2 h ABF, and HbA1c were recorded during the first visit. Then, the patients were counseled for a follow-up visit in the same diabetes center after 3 months with their relevant investigation reports. Again, in the follow-up visit information of FBG, 2 h ABF, HbA1c, height, weight, and any history of hypoglycemia in the past 3 months were recorded in the data collection form. During follow-up visits, few patients were dropped out because some patients did not come in follow-up and some did not do any investigations which were advised. Finally, a total of 100 patients were included in the study group. Among them 50 patients were included in Group I who were in premixed 30/70 insulin (conventional or analog) with or without oral antidiabetic drugs and 50 patients in Group II who were in glargine-based basal-bolus insulin with or without oral antidiabetic drugs. Qualitative data were expressed as frequency distribution and percentage and then compared by Chi-square test. Quantitative data were expressed as mean ± SD. The P ≤ 0.05 was considered statically significant at 95% confidence interval. The data were analyzed using statistical software SPSS (IBM SPSS Statistics for Windows, Version 22.0, Armonk, NY: IBM Corp.).
| Results|| |
In this study, most of the patients (38.0%) were between 50 and 59 years of age group in both treatment groups, and the mean age of the patients was 48.24 ± 9.75 years in Group I and 49.80 ± 9.17 years in Group II. Out of 100 cases male patients were predominant in both groups, 58.0% in Group I and 54.0% in Group II [Figure 1]. Most of the respondents were housewives (36.0%) in both groups. The monthly family income of most of the respondents (42.0%) was in between 10,000 and ≤3000 taka and most of them (27.0%) had completed their HSC education and also 14.0% were illiterate. Maximum respondents had a positive family history of diabetes 76.0% and 82.0% in Group I and in Group II, respectively. In this study, most of the patients had their duration of Type 2 diabetes was <5 years, 56.0% in Group I and 62.0% in Group II. In this study, it is observed that mean body weight was significantly increased from 59.82 ± 12.33 kg to 60.40 ± 13.38 kg in Group I and from 59.00 ± 12.36 kg to 60.33 ± 12.97 kg in Group II after 12-week of treatment [Figure 2], but in comparison between two groups, there was no significant (P = 0.741) difference. After 12 weeks, 64.0% of patients in Group I and 68.0% of patients in Group II gained body weight. The mean BMI increased significantly from 23.71 ± 4.69 kg/m2 to 24.10 ± 4.17 kg/m2 in Group I and from 24.00 ± 4.30 kg/m2 to 24.43 ± 4.59 kg/m2 in Group II after 12 weeks, but mean BMI compared between two groups after 12 weeks, there was no significant difference. The mean HbA1c level reduced significantly in both insulin groups after 12 weeks, from 10.40 ± 2.17% to 7.76 ± 1.41% and from 10.41 ± 1.80% to 7.63 ± 1.37% in Group I and in Group II, respectively. 48% of patients in Group I and 56% of patients in Group II achieved their HbA1c target <7% after 12 weeks of treatment. In this study, both FBG and blood glucose 2 h ABF also reduced significantly in both insulin groups. About 28% of patients in Group I and 20% of patients in Group II [Figure 3] gave a history of hypoglycemia during the study period.
| Discussion|| |
This observational study has been carried out to compare the effect of premixed 30/70 insulin and glargine-based basal-bolus insulin regimen on BMI of Type 2 diabetes patients. The study also extended to find out the effect of these two insulin regimens on glycemic control of the patients and also observe hypoglycemia that has occurred during the study period. Data were collected from two diabetes centers. A total of 100 patients were selected attending in the Endocrinology outpatient department of Dhaka Medical College Hospital and the outpatient department of Ibrahim General Hospital, Mirpur, Dhaka, according to the inclusion and exclusion criteria of the study.
In this study, the demographic profile showed that insulin was prescribed more to male patients (58.0% in Group I and 54.0% in Group II) in comparison to female patients (42.0% in Group I and 46.0% in Group II) which may indicate that males were predominantly coming for consultation than female. The reason of male predominance is probably due to socioeconomic factors or less awareness of female patients to utilize health care facilities. This finding is similar to a previous study conducted by Bhuyan and Fardus, in 2019, on diabetes patients in Bangladesh showed males were more (53.6%) than females (46.4%), but Fottrell et al., in 2018 showed number female was more than male in their study. The predominant age group of this study was 50–59 years (36% in Group 1 and 40% in Group 2) and the second large age group was 40–49 years (26% in Group I and 24% in Group II), which is similar with previous studies. In the study of the glycemic status of Type 2 diabetes subjects on different antidiabetic management conducted by Samdani et al., in 2017, showed major age group was 50–59 years (37.5%) but Hira, Miah, and Akash in 2018 showed predominant age group was 40–49 years in their study.
In this study, most of the respondents were housewife, about 36.0% of the whole population (32.0% in Group I and 40.0% in Group II). Other predominant occupations were service (21.0%), business (16.0%), retired (14.0%), labor (4.0%), farmer (4.0%), and others (5.0%) which were similar with other studies. The study conducted by Siddique et al., 2017, also showed predominant occupation was housewife (55.6%) and the second-most was the service (17.3%). The highest number of respondents, about 42.0% of the whole population (40.0% in Group I and 44.0% in Group II) were observed in the monthly income group of 10,001–≤30,000 taka and the second most (32.0%) monthly income was 30,001–≤50,000 taka. A study conducted by Samdani et al., in 2017, also showed similar results.
Most of the patients in this study were completed their higher secondary education (27.0%), followed by primary education (21.0%), SSC (18.0%), graduate (17.0%), and illiterate (14.0%) and the least was postgraduate (3.0%). This reflects that educated persons are more conscious and comes to take health-care facilities more than the illiterate. Islam et al., in 2016, also showed similar results in their study. In this study, patients of both groups have a positive family history of diabetes mellitus, 76.0% and 82.0% in Group I and Group II respectively. Haque et al., in 2017, in their study conducted on Type 2 diabetes patients of Bangladesh also shown most of the patients had a positive family history of diabetes, but most of the patients had a negative family history of diabetes in the study conducted by Afroz et al., in 2019. In this study, respondents were distributed by the duration of Type 2 diabetes (<5 years and ≥5 years). The duration of Type 2 diabetes in most of the patients was <5 years, 56.0% in Group I and 62.0% in Group II. Islam et al., in 2015, in their study show similar findings. In this study, mean baseline body weight was 59.82 ± 12.33 kg in Group I and 59.00 ± 12.36 kg in Group II. After 12 weeks of treatment, there was a significantly increased of body weight in both groups. From 59.82 ± 12.33 kg to 60.40 ± 13.38 kg in Group I who were prescribed with premixed 30/70 and from 59.00 ± 12.36 kg to 60.33 ± 12.97 kg in Group II who were prescribed with glargine-based basal-bolus regimen. However, the mean body weight compared (60.40 ± 13.38 kg in Group I vs. 60.33 ± 12.97 kg in Group II) between the two study groups after 12 weeks of treatment was not statistically significant.
A similar type of study was conducted by Shanmugasundar et al., in 2012, in Chandigarh, India, with 50 Type 2 diabetes patients for 12 weeks also found that there was a significant increase in body weight in both study groups. Their study has shown increased body weight from 74.6 ± 11.9 kg to 76.0 ± 11.6 kg in the premixed arm and from 85.5 ± 14.0 kg to 86.9 ± 14.4 kg in glargine-based basal-bolus arm after 12 weeks of treatment but in comparison between two groups there was no significant difference. A 24 weeks, of random study with 160 patients conducted by Jin et al., in 2016, shown body weight was significantly increased by 1.05 ± 0.36 kg in the premixed group and by 1.22 ± 0.37 kg in the basal-bolus group from baseline after the study period but in comparison of weight gain between two groups, there was no significant difference.
In this study, 64.0% of patients with premixed insulin and 68.0% of patients with basal-bolus insulin gained body weight after 12 weeks. Body weight remains unchanged in 20.0% of patients in Group I and 16.0% of patients in Group II and weight loss has occurred in 16.0% of cases in both groups. A prospective study conducted by Jansen et al., in 2014 for 12 months with 79 Type 2 diabetes patients on insulin-associated weight gain in Type 2 diabetes 71% of patients gained weight and 29% of patients showed stable body weight or even lost body weight after 12 months. In this study, maximum respondents (44.0%) in Group I were in BMI group 25–29.9 kg/m2 and the maximum respondents (46.0%) in Group II were in the normal range of BMI that is 18.5–24.9 kg/m2. The mean baseline BMI was 23.71 ± 4.69 kg/m2 and 24.00 ± 4.30 kg/m2 for Group I and Group II, respectively. BMI increased significantly in both study groups after 12 weeks of treatment from 23.71 ± 4.69 kg/m2–24.10 ± 4.17 kg/m2 in Group I and from 24.00 ± 4.30 kg/m2–24.43 ± 4.59 kg/m2 in Group II. However, the mean BMI (24.10 ± 4.17 kg/m2 vs. 24.43 ± 4.59 kg/m2) compared between two study groups after 12 weeks was not statistically significant. Shanmugasunder et al., in 2012, showed in study that BMI increased by 0.58 ± 0.61 kg/m2 in premixed and 0.62 ± 0.6 kg/m2 in the basal-bolus arm which were significant, but the comparison between the two groups was not significant. In this study, patients in both study groups have shown improvement in overall glycemic control during the study period. The result showed a significant reduction of HbA1c after 12 weeks of treatment from 10.40 ± 2.17% to 7.76 ± 1.41% and 10.41 ± 1.80% to 7.63 ± 1.37% in Group I and Group II, respectively. However, the mean HbA1c level (7.76% ± 1.41% vs. 7.63% ± 1.37%) compared between the two study groups after 12 weeks was no significant difference. Anyanwagu et al., in 2017, in 24 weeks, randomized study showed there was a significant reduction of HbA1c by 0.28% and 1.4% in basal-bolus and premixed 30/70 arm, respectively, but there was no significant difference in comparison between the two groups.
According to the American Diabetes Association, 2018, the HbA1c target <7% was achieved by 48.0% of patients in Group I and 56.0% of patients in Group II after 12-week of treatment. Fritsche et al., 2010, showed in their study that a higher proportion of subject achieved HbA1c <7% in the basal-bolus arm (46.6%) than premixed arm (27.9%). In the aspect of FBG this study has showed a significant reduction of fasting blood glucose in both groups from 12.50 ± 4.28 mmol/L to 6.98 ± 1.52 mmol/L in Group I and from 12.49 ± 5.64 mmol/L to 6.64 ± 1.00 mmol/L in Group II. However, the mean FBG level (6.98 ± 1.52 mmol/L vs. 6.64 ± 1.00 mmol/L) compared between the two study groups was no significant difference. The study conducted by Shi, Li, and Hou, 2017, showed a significant reduction of fasting blood sugar by (−1.58 ± 3.32 mmol/L) from 10.23 ± 1.23 mmol/L in the premixed arm and by (−2.04 ± 3.35 mmol/L) from 10.81 ± 1.57 mmol/L in the basal-bolus arm. In this study, glycemic target of FBG 4.4–7.2 mmol/L was achieved by 52.0% of patients in Group I and 60.0% of patients in Group II, but the rest of the patients failed to achieve the glycemic target.
In our study, there is also a significant reduction of blood glucose 2 h after breakfast in both groups from 16.86 ± 6.93 mmol/L to 9.35 ± 1.47 mmol/L in Group I and from 17.85 ± 5.36 mmol/L to 10.05 ± 2.18 mmol/L in Group II. However, the mean blood glucose level of 2 h ABF (9.35 ± 1.47 mmol/L vs. 10.05 ± 2.18 mmol/L) compared between the two study groups was not statistically significant. Linjawi et al., in 2018, showed in the study there was a significant reduction of blood sugar 2 h after breakfast at 1.29 mmol/L in the premixed arm and 1.85 mmol/L in the basal-bolus arm, but there was no significant difference between two groups. In this study, the glycemic target of 2 h ABF <10 mmol/L was achieved by 58.0% in Group I and 64.0% in Group II, but the rest of the patients failed to achieve the glycemic target.
In this study, 28.0% of patients in Group I and 20.0% of patients in Group II gave a history of hypoglycemia during the period of 12-week, but none of the patients required hospital admission. Jin et al., in 2016, showed in their study that patients of the basal-bolus group experienced more hypoglycemia than the premixed group, but Home et al., n 2015, in their study showed more patients in the premixed group (19.1%) had hypoglycemia than basal-bolus group (14.8%).
| Conclusion|| |
Based on this study's findings, it can be concluded that both premixed 30/70 and glargine-based basal-bolus regimen has an effect on weight gain and BMI change in Type 2 diabetes patients but in comparison between the two groups, there is no significant difference. Both insulin regimens have a good glycemic control effect and also more patients in glargine-based basal-bolus group achieved the glycemic target. Hence, physicians can use both insulin regimens as per patients' need.
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[Figure 1], [Figure 2], [Figure 3]