Effect of poor glycemic control on the prevalence and determinants of anemia and chronic kidney disease among type 2 diabetes mellitus patients in Jordan: An observational cross-sectional study

Ahmed Al-Dwairi; Othman Al-Shboul; Doa’a G. F. Al-U’datt; Rami Saadeh; Mohammad AlQudah; Adi Khassawneh; Mahmoud Alfaqih; Alhakam Albtoush; Aysam Hweidi; Abdulaziz Alnemer

doi:10.1371/journal.pone.0313627

Peer Review History

Original SubmissionJuly 11, 2024
5 Aug 2024 Decision Letter - Jaspinder Kaur, Editor PONE-D-24-28044Effect of Poor Glycemic Control on the Prevalence and Determinants of Anemia and Chronic Kidney Disease Among Type 2 Diabetes Mellitus Patients in Jordan: An Observational Cross-sectional StudyPLOS ONE Dear Dr. Al-Dwairi, Thank you for submitting your manuscript to PLOS ONE. After careful consideration, we feel that it has merit but does not fully meet PLOS ONE’s publication criteria as it currently stands. Therefore, we invite you to submit a revised version of the manuscript that addresses the points raised during the review process. Please submit your revised manuscript by Sep 19 2024 11:59PM. If you will need more time than this to complete your revisions, please reply to this message or contact the journal office at plosone@plos.org. When you're ready to submit your revision, log on to https://www.editorialmanager.com/pone/ and select the 'Submissions Needing Revision' folder to locate your manuscript file. 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Please include your tables as part of your main manuscript and remove the individual files. Please note that supplementary tables (should remain/ be uploaded) as separate "supporting information" files 6. Please review your reference list to ensure that it is complete and correct. If you have cited papers that have been retracted, please include the rationale for doing so in the manuscript text, or remove these references and replace them with relevant current references. Any changes to the reference list should be mentioned in the rebuttal letter that accompanies your revised manuscript. If you need to cite a retracted article, indicate the article’s retracted status in the References list and also include a citation and full reference for the retraction notice. [Note: HTML markup is below. Please do not edit.] Reviewers' comments: Reviewer's Responses to Questions Comments to the Author 1. Is the manuscript technically sound, and do the data support the conclusions? The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented. Reviewer #1: Yes Reviewer #2: Partly ******** 2. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: Yes Reviewer #2: Yes ****** 3. Have the authors made all data underlying the findings in their manuscript fully available? The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified. Reviewer #1: Yes Reviewer #2: Yes ****** 4. Is the manuscript presented in an intelligible fashion and written in standard English? PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here. Reviewer #1: Yes Reviewer #2: Yes ****** 5. Review Comments to the Author Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters) Reviewer #1: This is a cross-sectional study that determined the effect of poor glycemic control on the prevalence and determinants of anemia and CKD in Type 2 DM patients. This study in Jordan with 120 controlled DM patients and indexed match uncontrolled 120 DM patients recruited from December 2018 to December 2019 showed a higher prevalence of anemia in the uncontrolled T2DM group. Also, female gender was positively associated with anemia in T2DM patients . Using the multivariate model, the authors noted that age, female gender, and CKD were positively associated with anemia, and the univariate model showed increased cases of anemia with poor glycemic control T2DM patients. Major Comments: 1. Introduction: It has a well-written background and highlights the problem under study. However, it can be more concise especially the ending of the first paragraph explaining the pathophysiology of DM. It is great that you have claimed that your study is the first of its kind but since it is a very strong statement I want to make sure that you have reviewed the existing article well. 2. Method: It is very detailed and clear. It would be better if you would also add the reference for the insulin resistance score formula. 3. Result: This section seems lengthy to me, there is repetition of information. It would be better if you would only highlight important points from the table. Since the biochemical profiles are clearly given in the table all the numerical values need not be explained. 4. Discussion: This section is really great. I like how you have backed all the comparisons with possible explanations. Minor Comments: 5. In the abstract section, it would be better if you included the binomial logistic regression in the method section than the result section. 6. In the first paragraph of the discussion, you mentioned how your study stands out as it explores sex-based differences in factors influencing anemia and CKD which can be kept in the last paragraph of your discussion. Reviewer #2: Under DISCUSSION LINE 7:'were controlled' should be 'where controlled' Since the sample age were adults from 18, females with possible menorrhagia in the premenopausal age group should be excluded since they already have baseline iron deficiency anemia and may inflate the number of females with anemia. ****** 6. PLOS authors have the option to publish the peer review history of their article (what does this mean?). If published, this will include your full peer review and any attached files. If you choose “no”, your identity will remain anonymous but your review may still be made public. Do you want your identity to be public for this peer review? For information about this choice, including consent withdrawal, please see our Privacy Policy. Reviewer #1: Yes: Rojeena Adhikari Reviewer #2: No ******** [NOTE: If reviewer comments were submitted as an attachment file, they will be attached to this email and accessible via the submission site. Please log into your account, locate the manuscript record, and check for the action link "View Attachments". If this link does not appear, there are no attachment files.] While revising your submission, please upload your figure files to the Preflight Analysis and Conversion Engine (PACE) digital diagnostic tool, https://pacev2.apexcovantage.com/. PACE helps ensure that figures meet PLOS requirements. To use PACE, you must first register as a user. Registration is free. Then, login and navigate to the UPLOAD tab, where you will find detailed instructions on how to use the tool. If you encounter any issues or have any questions when using PACE, please email PLOS at figures@plos.org. Please note that Supporting Information files do not need this step. https://doi.org/10.1371/journal.pone.0313627.r001
Revision 1
8 Oct 2024 Author Response Dear Editor, We sincerely appreciate the opportunity to revise and resubmit our manuscript titled “Effect of Poor Glycemic Control on the Prevalence and Determinants of Anemia and Chronic Kidney Disease Among Type 2 Diabetes Mellitus Patients in Jordan: An Observational Cross-sectional Study" (Manuscript ID: [PONE-D-24-28044]). We are grateful for the constructive feedback provided by both you and the reviewers, which has substantially improved the quality of our manuscript. We have carefully addressed each of the reviewers' comments and made the necessary revisions accordingly. A detailed point-by-point response is included to illustrate how we have incorporated these suggestions into the manuscript. Financial Disclosure: We have clearly stated that “The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript." References: In response to the reviewers’ comments, we have updated the references to adhere to PLoS One's style. Additionally, we have cited an additional paper as requested by the reviewer (ref 26). During our review, we identified a duplicate reference (originally listed as ref 10 and 34) and have removed the duplicate, updating the citations throughout the manuscript accordingly. Data Availability: To ensure transparency, we have made the data supporting our findings publicly available. The minimum dataset has been deposited on the Open Science Framework platform and can be accessed via the following link: https://osf.io/t3fyb/files/osfstorage/66ecf737dfdeb8778412c673. Enclosed, you will find our detailed point-by-point responses to the reviewers’ comments, along with the corresponding revisions made in the manuscript. We hope the revised manuscript meets the journal's expectations and look forward to your feedback. Sincerely, Ahmed Al-Dwairi, PhD ______________________________________________________________________________ Review Comments to the Author Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters) Reviewer #1: This is a cross-sectional study that determined the effect of poor glycemic control on the prevalence and determinants of anemia and CKD in Type 2 DM patients. This study in Jordan with 120 controlled DM patients and indexed match uncontrolled 120 DM patients recruited from December 2018 to December 2019 showed a higher prevalence of anemia in the uncontrolled T2DM group. Also, female gender was positively associated with anemia in T2DM patients. Using the multivariate model, the authors noted that age, female gender, and CKD were positively associated with anemia, and the univariate model showed increased cases of anemia with poor glycemic control T2DM patients. Major Comments: 1. Introduction: It has a well-written background and highlights the problem under study. However, it can be more concise especially the ending of the first paragraph explaining the pathophysiology of DM. It is great that you have claimed that your study is the first of its kind but since it is a very strong statement I want to make sure that you have reviewed the existing article well. Response: Thank you, we appreciate the feedback and have made the necessary revisions. We have condensed the first paragraph to enhance its clarity and conciseness, particularly in the section explaining the pathophysiology of diabetes mellitus (DM). 2. Method: It is very detailed and clear. It would be better if you would also add the reference for the insulin resistance score formula. Response: Thank you, we added the proper citation. 3. Result: This section seems lengthy to me, there is repetition of information. It would be better if you would only highlight important points from the table. Since the biochemical profiles are clearly given in the table all the numerical values need not be explained. Response: Thank you, we have revised the results section. 4. Discussion: This section is really great. I like how you have backed all the comparisons with possible explanations. Response: Thank you for the positive feedback on the discussion section. We are glad that the explanations and comparisons were clear and well-supported. Minor Comments: 5. In the abstract section, it would be better if you included the binomial logistic regression in the method section than the result section. Response: Thank you, we have revised the abstract accordingly. 6. In the first paragraph of the discussion, you mentioned how your study stands out as it explores sex-based differences in factors influencing anemia and CKD which can be kept in the last paragraph of your discussion. Response: Thank you, we have revised this part accordingly. Reviewer #2: Under DISCUSSION LINE 7:'were controlled' should be 'where controlled' Since the sample age were adults from 18, females with possible menorrhagia in the premenopausal age group should be excluded since they already have baseline iron deficiency anemia and may inflate the number of females with anemia. Response: Thank you for the valuable comment. We have modified 'were controlled' to 'where controlled'. This is an age-, gender-, and BMI-matched study. To mitigate the risk of overestimating anemia prevalence due to baseline iron deficiency anemia, we matched participants by gender and ensured that other relevant confounding factors, such as iron status, were statistically controlled for in our analysis. This approach ensures that the findings accurately reflect the associations between poor glycemic control, anemia, and CKD, independent of confounding variables like menorrhagia. Attachments Attachment Submitted filename: Response to Reviewers 2.docx https://doi.org/10.1371/journal.pone.0313627.r002
18 Oct 2024 Decision Letter - Apeksha Niraula, Editor PONE-D-24-28044R1Effect of Poor Glycemic Control on the Prevalence and Determinants of Anemia and Chronic Kidney Disease Among Type 2 Diabetes Mellitus Patients in Jordan: An Observational Cross-sectional StudyPLOS ONE Dear Dr. Al-Dwairi, Thank you for submitting your manuscript to PLOS ONE. After careful consideration, we feel that it has merit but does not fully meet PLOS ONE’s publication criteria as it currently stands. Therefore, we invite you to submit a revised version of the manuscript that addresses the points raised during the review process. Methodology part needs to be rewritten with major focus on sample enrollment and sample size calculation. For analyte analysis, write down the method employed for determination of serum levels of insulin, fasting blood glucose, total cholesterol, and triglycerides. Please submit your revised manuscript by Dec 02 2024 11:59PM. If you will need more time than this to complete your revisions, please reply to this message or contact the journal office at plosone@plos.org. When you're ready to submit your revision, log on to https://www.editorialmanager.com/pone/ and select the 'Submissions Needing Revision' folder to locate your manuscript file. Please include the following items when submitting your revised manuscript: A rebuttal letter that responds to each point raised by the academic editor and reviewer(s). You should upload this letter as a separate file labeled 'Response to Reviewers'. A marked-up copy of your manuscript that highlights changes made to the original version. You should upload this as a separate file labeled 'Revised Manuscript with Track Changes'. An unmarked version of your revised paper without tracked changes. You should upload this as a separate file labeled 'Manuscript'. If you would like to make changes to your financial disclosure, please include your updated statement in your cover letter. Guidelines for resubmitting your figure files are available below the reviewer comments at the end of this letter. If applicable, we recommend that you deposit your laboratory protocols in protocols.io to enhance the reproducibility of your results. Protocols.io assigns your protocol its own identifier (DOI) so that it can be cited independently in the future. For instructions see: https://journals.plos.org/plosone/s/submission-guidelines#loc-laboratory-protocols. Additionally, PLOS ONE offers an option for publishing peer-reviewed Lab Protocol articles, which describe protocols hosted on protocols.io. Read more information on sharing protocols at https://plos.org/protocols?utm_medium=editorial-email&utm_source=authorletters&utm_campaign=protocols. We look forward to receiving your revised manuscript. Kind regards, Apeksha Niraula, M.D., Biochemistry Academic Editor PLOS ONE Journal Requirements: Please review your reference list to ensure that it is complete and correct. If you have cited papers that have been retracted, please include the rationale for doing so in the manuscript text, or remove these references and replace them with relevant current references. Any changes to the reference list should be mentioned in the rebuttal letter that accompanies your revised manuscript. If you need to cite a retracted article, indicate the article’s retracted status in the References list and also include a citation and full reference for the retraction notice. Additional Editor Comments: Methodology part needs to be rewritten with major focus on sample enrollment and sample size calculation. For analyte analysis, write down the method employed for determination of serum levels of insulin, fasting blood glucose, total cholesterol, and triglycerides. [Note: HTML markup is below. Please do not edit.] Reviewers' comments: Reviewer 1: This is a cross-sectional study that determined the effect of poor glycemic control on the prevalence and determinants of anemia and CKD in Type 2 DM patients. This study in Jordan with 120 controlled DM patients and indexed match uncontrolled 120 DM patients recruited from December 2018 to December 2019 showed a higher prevalence of anemia in the uncontrolled T2DM group. Also, female gender was positively associated with anemia in T2DM patients . Using the multivariate model, the authors noted that age, female gender, and CKD were positively associated with anemia, and the univariate model showed increased cases of anemia with poor glycemic control T2DM patients. Major Comments: 1. Introduction: It has a well-written background and highlights the problem under study. However, it can be more concise especially the ending of the first paragraph explaining the pathophysiology of DM. It is great that you have claimed that your study is the first of its kind but since it is a very strong statement I want to make sure that you have reviewed the existing article well. 2. Method: It is very detailed and clear. It would be better if you would also add the reference for the insulin resistance score formula. 3. Result: This section seems lengthy to me, there is repetition of information. It would be better if you would only highlight important points from the table. Since the biochemical profiles are clearly given in the table all the numerical values need not be explained. 4. Discussion: This section is really great. I like how you have backed all the comparisons with possible explanations. Minor Comments: 5. In the abstract section, it would be better if you included the binomial logistic regression in the method section than the result section. 6. In the first paragraph of the discussion, you mentioned how your study stands out as it explores sex-based differences in factors influencing anemia and CKD which can be kept in the last paragraph of your discussion. [NOTE: If reviewer comments were submitted as an attachment file, they will be attached to this email and accessible via the submission site. Please log into your account, locate the manuscript record, and check for the action link "View Attachments". If this link does not appear, there are no attachment files.] While revising your submission, please upload your figure files to the Preflight Analysis and Conversion Engine (PACE) digital diagnostic tool, https://pacev2.apexcovantage.com/. PACE helps ensure that figures meet PLOS requirements. To use PACE, you must first register as a user. Registration is free. Then, login and navigate to the UPLOAD tab, where you will find detailed instructions on how to use the tool. If you encounter any issues or have any questions when using PACE, please email PLOS at figures@plos.org. Please note that Supporting Information files do not need this step. https://doi.org/10.1371/journal.pone.0313627.r003
Revision 2
25 Oct 2024 Author Response Dear Editor, We sincerely appreciate the opportunity to revise and resubmit our manuscript titled “Effect of Poor Glycemic Control on the Prevalence and Determinants of Anemia and Chronic Kidney Disease Among Type 2 Diabetes Mellitus Patients in Jordan: An Observational Cross-sectional Study" (Manuscript ID: [PONE-D-24-28044]). We are grateful for the constructive feedback provided by the reviewers. We have thoroughly addressed their comments and made the necessary revisions to enhance the manuscript. To facilitate the review process, we have included a detailed point-by-point response that outlines how we have incorporated their suggestions into the revised manuscript. Thank you for your consideration. Sincerely, Ahmed Al-Dwairi, PhD __________________________________________________________________________ Reviewer: Methodology part needs to be rewritten with major focus on sample enrollment and sample size calculation. For analyte analysis, write down the method employed for determination of serum levels of insulin, fasting blood glucose, total cholesterol, and triglycerides. Response: Thank you for your constructive feedback. In response to your comments, we have made the necessary revisions to the Methodology section, as outlined below: Sample Enrollment and Sample Size Calculation: We have now provided a detailed description of the sample enrollment process and sample size calculation. The sample size was calculated based on an estimated prevalence of type 2 diabetes mellitus (T2DM) of 15% in the adult population of Jordan, with a 95% confidence level and a 5% margin of error. The calculated sample size was 196 based on the standard formula for calculating sample size for population proportions: n= Z2 × p × (1-p) /E2. These details have been incorporated into the revised Methods section. Analyte Analysis: As per your request, we have clarified the methods employed for the determination of serum insulin, fasting blood glucose, total cholesterol, and triglycerides. The following updates were made: • Serum Insulin: Serum insulin levels were measured using a validated enzyme-linked immunosorbent assay (ELISA), which provides high specificity and sensitivity. • Fasting Blood Glucose: Glucose levels were analyzed using the glucose oxidase method, utilizing the cobas® modular analyzer system (Roche Diagnostics, Mannheim, Germany). • Total Cholesterol and Triglycerides: Both total cholesterol and triglyceride levels were measured using enzymatic colorimetric assays, also performed on the cobas® modular analyzer system. These methodological details have been added to the Methods section to enhance the clarity and accuracy of our analysis description. We appreciate your insightful comments, which have significantly improved our manuscript. Thank you for your thorough review. Sincerely, Ahmed Al-Dwairi, PhD Attachments Attachment Submitted filename: Response to reviewers.docx https://doi.org/10.1371/journal.pone.0313627.r004
29 Oct 2024 Decision Letter - Apeksha Niraula, Editor Effect of Poor Glycemic Control on the Prevalence and Determinants of Anemia and Chronic Kidney Disease Among Type 2 Diabetes Mellitus Patients in Jordan: An Observational Cross-sectional Study PONE-D-24-28044R2 Dear Dr. Al-Dwairi, We’re pleased to inform you that your manuscript has been judged scientifically suitable for publication and will be formally accepted for publication once it meets all outstanding technical requirements. Within one week, you’ll receive an e-mail detailing the required amendments. When these have been addressed, you’ll receive a formal acceptance letter and your manuscript will be scheduled for publication. An invoice will be generated when your article is formally accepted. Please note, if your institution has a publishing partnership with PLOS and your article meets the relevant criteria, all or part of your publication costs will be covered. Please make sure your user information is up-to-date by logging into Editorial Manager at Editorial Manager® and clicking the ‘Update My Information' link at the top of the page. If you have any questions relating to publication charges, please contact our Author Billing department directly at authorbilling@plos.org. If your institution or institutions have a press office, please notify them about your upcoming paper to help maximize its impact. If they’ll be preparing press materials, please inform our press team as soon as possible -- no later than 48 hours after receiving the formal acceptance. Your manuscript will remain under strict press embargo until 2 pm Eastern Time on the date of publication. For more information, please contact onepress@plos.org. Kind regards, Apeksha Niraula, M.D., Biochemistry Academic Editor PLOS ONE Additional Editor Comments (optional): Reviewers' comments: https://doi.org/10.1371/journal.pone.0313627.r005
Formally Accepted
6 Nov 2024 Acceptance Letter - Apeksha Niraula, Editor PONE-D-24-28044R2 PLOS ONE Dear Dr. Al-Dwairi, I'm pleased to inform you that your manuscript has been deemed suitable for publication in PLOS ONE. Congratulations! Your manuscript is now being handed over to our production team. At this stage, our production department will prepare your paper for publication. This includes ensuring the following: * All references, tables, and figures are properly cited * All relevant supporting information is included in the manuscript submission, * There are no issues that prevent the paper from being properly typeset If revisions are needed, the production department will contact you directly to resolve them. If no revisions are needed, you will receive an email when the publication date has been set. At this time, we do not offer pre-publication proofs to authors during production of the accepted work. Please keep in mind that we are working through a large volume of accepted articles, so please give us a few weeks to review your paper and let you know the next and final steps. Lastly, if your institution or institutions have a press office, please let them know about your upcoming paper now to help maximize its impact. If they'll be preparing press materials, please inform our press team within the next 48 hours. Your manuscript will remain under strict press embargo until 2 pm Eastern Time on the date of publication. For more information, please contact onepress@plos.org. If we can help with anything else, please email us at customercare@plos.org. Thank you for submitting your work to PLOS ONE and supporting open access. Kind regards, PLOS ONE Editorial Office Staff on behalf of Dr. Apeksha Niraula Academic Editor PLOS ONE https://doi.org/10.1371/journal.pone.0313627.r006

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