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Clinical Research on Type 2 Diabetes: A Promising and Multifaceted Landscape

Type 2 diabetes constitutes an imposing epidemiological, economic, and scientific global challenge. The chronic complications of type 2 diabetes are a major cause of mortality and disability worldwide [ 1 , 2 ]. Clinical research is the main way to gain knowledge about long-term diabetic complications and reduce the burden of diabetes. This allows for designing effective programs for screening and follow-up and fine-targeted therapeutic interventions. However, new research methodologies are needed to obtain more accurate and useful insights into the biological and clinical processes involved in diabetic complication development.

During the last few years, new approaches for clinical research have incorporated digital tools to analyze the complex physiopathological background of type 2 diabetes. In this Special Issue, entitled “ Clinical Research on Type 2 Diabetes and Its Complications ” and published in the Journal of Clinical Medicine ( https://www.mdpi.com/journal/jcm/special_issues/Type_2_Diabetes_Complications ), some valuable digital methodologies were used in different studies focusing on the type 2 diabetes syndrome. Novel machine learning techniques for predicting long-term complications are one of these approaches, as the studies of Huang, Rashid, and Shin et al. depict [ 3 , 4 , 5 ]. The data presented by these authors suggest that machine learning may be more accurate in predicting diabetic microvascular complications than traditional methods. Additionally, digital tools such as artificial intelligence and machine learning can be implemented through an automated and rapid process.

Among the frequent causes of frustration for people with diabetes and the health care providers involved in their management is the delayed detection of diabetic complications. The outlook of clinical research appears promising in the near future owing to the development and implementation of advanced methods for the detection of early alterations in the micro- and macrovascular complications associated with diabetes. Two papers in this Special Issue cover the use of specific biomarkers tracing the progress of diabetic cardiovascular complications [ 6 , 7 ]. In another contribution, Lee et al. revisit the long-term glycemic variability and its relationship with end-stage kidney disease [ 8 ].

Besides the genetic approach, the application of digital techniques, including machine learning and artificial intelligence, and novel biomarkers could be crucial for individualized type 2 diabetes management, which is the backbone of precision medicine.

Two review papers address the complications that are non-traditionally linked to type 2 diabetes, although currently under exhaustive research: bone health and non-alcoholic fatty liver disease [ 9 , 10 ]. The multifaceted nature of type 2 diabetes is clearly visualized owing to the holistic angle used by these approaches.

The efficacy and safety of new type 2 diabetes pharmacological treatment are covered by three original papers [ 11 , 12 , 13 ]. The Yu-Chuan Kang et al. study includes a large population sample and an extended follow-up to evaluate the association between dipeptidyl peptidase-4 inhibitors and diabetic retinopathy [ 13 ]. This could be the first signal for a new safety risk of a pharmacological class of drugs used by millions worldwide.

The COVID-19 pandemic was first reported in China in December 2019 and continues to be a devastating condition for global health and economy. The COVID-19 disease has immediate implications for common chronic metabolic disorders such as type 2 diabetes. Both direct infection and the associated distress due to preventive measures in the general population have worsened the control of type 2 diabetes. Some factors indicate that COVID-19 or other coronavirus-caused diseases can be seasonal or persistent in the future. Type 2 diabetes has a strong negative effect on the prognosis of patients with COVID-19. Three papers in this Special Issue review the implications of this disease in relation to diabetes [ 14 , 15 , 16 ].

Finally, the aim of researchers in this field should be to make all these remarkable advances accessible to those populations experiencing more difficulties due to sociodemographic factors such as cultural deprivation, sex discrimination, or limited income [ 17 , 18 , 19 ].

Acknowledgments

The authors acknowledge the continuous editorial assistance of Nicole Quinn, Always English S.L.

Funding Statement

This research received no external funding.

Author Contributions

Conceptualization, writing—original draft preparation, writing—review and editing were equally done by F.G.-P. and C.A. All authors have read and agreed to the published version of the manuscript.

Conflicts of Interest

The authors declare no conflict of interest.

Publisher’s Note: MDPI stays neutral with regard to jurisdictional claims in published maps and institutional affiliations.

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Type 2 diabetes articles from across Nature Portfolio

Type 2 diabetes mellitus, the most frequent subtype of diabetes, is a disease characterized by high levels of blood glucose (hyperglycaemia). It arises from a resistance to and relative deficiency of the pancreatic β-cell hormone insulin.

Linking gut microbial strains and functions to diabetes in an international population

Although gut microorganisms have been associated with type 2 diabetes, the mechanisms involving specific microbial strains remain unidentified. Now, a comprehensive study has analyzed 8,117 shotgun metagenomes from the USA, Europe, Israel and China, providing cross-population microbial signatures in a strain-resolved manner and new mechanistic insights into type 2 diabetes.

Latest Research and Reviews

The downregulation of SCGN induced by lipotoxicity promotes NLRP3-mediated β-cell pyroptosis

• Shuhui Ouyang
• Sunmin Xiang

Association of urinary creatinine excretion and body mass index with diabetic retinopathy in patients with type 2 diabetes

• Jin Ook Chung
• Seon-Young Park
• Min Young Chung

Risk of chronic kidney disease in patients with a hyperglycemic crisis as the initial presentation of type 2 diabetes

• Chun-Ta Huang
• Chih-Hsin Muo
• Pei-Chun Chen

Enhanced disulphide bond stability contributes to the once-weekly profile of insulin icodec

In this work, the authors described how the enhanced disulphide bond stability of insulin icodec enables its once-weekly profile. Disulphide bonds in insulin are subject to thiol-disulphide exchange in plasma leading to splitting insulin into its inactive chains, making the insulin disulfide stability crucial for its long duration of action.

• František Hubálek
• Christian N. Cramer
• Thomas B. Kjeldsen

LGR signaling mediates muscle-adipose tissue crosstalk and protects against diet-induced insulin resistance

Obesity induces insulin resistance and impairs insulin signaling, causing diabetes. Here, the authors show that BMP and LGR signaling mediate communication between muscle, neuronal, and adipose tissues to enhance insulin signaling, identifying LGR as key in protecting against insulin resistance.

• Olga Kubrak
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Risk factors associated with the severity of overactive bladder among Syrian patients with type 2 diabetes

• Fater A. Khadour
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News and Comment

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Patient educators and nurses can demonstrate the real-life use of health technologies.

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Bile acid receptor protects against diabetic cardiomyopathy

Activation of the bile acid receptor TGR5 inhibits CD36-mediated fatty acid uptake in cardiomyocytes and protects against cardiac lipotoxicity and the development of diabetic cardiomyopathy in mice, according to a new study.

• Irene Fernández-Ruiz

Response to comment on “Credibility of Chat-GPT in the assessment of obesity in type 2 diabetes according to the guidelines”

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Macrophage vesicles in antidiabetic drug action

Thiazolidinediones (TZDs) are potent insulin-sensitizing drugs, but their use is accompanied by adverse side-effects. Rohm et al. now report that TZD-stimulated macrophages release miR-690-containing vesicles that improve insulin sensitization and bypass unwanted side-effects.

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Metformin acts through appetite-suppressing metabolite: Lac-Phe

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Type 2 Diabetes Research At-a-Glance

The ADA is committed to continuing progress in the fight against type 2 diabetes by funding research, including support for potential new treatments, a better understating of genetic factors, addressing disparities, and more. For specific examples of projects currently funded by the ADA, see below.

Greg J. Morton, PhD

University of Washington

Project: Neurocircuits regulating glucose homeostasis

“The health consequences of diabetes can be devastating, and new treatments and therapies are needed. My research career has focused on understanding how blood sugar levels are regulated and what contributes to the development of diabetes. This research will provide insights into the role of the brain in the control of blood sugar levels and has potential to facilitate the development of novel approaches to diabetes treatment.”

The problem: Type 2 diabetes (T2D) is among the most pressing and costly medical challenges confronting modern society. Even with currently available therapies, the control and management of blood sugar levels remains a challenge in T2D patients and can thereby increase the risk of diabetes-related complications. Continued progress with newer, better therapies is needed to help people with T2D.

The project: Humans have special cells, called brown fat cells, which generate heat to maintain optimal body temperature. Dr. Morton has found that these cells use large amounts of glucose to drive this heat production, thus serving as a potential way to lower blood sugar, a key goal for any diabetes treatment. Dr. Morton is working to understand what role the brain plays in turning these brown fat cells on and off.

The potential outcome: This work has the potential to fundamentally advance our understanding of how the brain regulates blood sugar levels and to identify novel targets for the treatment of T2D.

Tracey Lynn McLaughlin, MD

Stanford University

Project: Role of altered nutrient transit and incretin hormones in glucose lowering after Roux-en-Y gastric bypass surgery

“This award is very important to me personally not only because the enteroinsular axis (gut-insulin-glucose metabolism) is a new kid on the block that requires rigorous physiologic studies in humans to better understand how it contributes to glucose metabolism, but also because the subjects who develop severe hypoglycemia after gastric bypass are largely ignored in society and there is no treatment for this devastating and very dangerous condition.”

The problem: Roux-en-Y gastric bypass (RYGB) surgery is the single-most effective treatment for type 2 diabetes, with persistent remission in 85% of cases. However, the underlying ways by which the surgery improves glucose control is not yet understood, limiting the ability to potentially mimic the surgery in a non-invasive way. Furthermore, a minority of RYGB patients develop severe, disabling, and life-threatening low-blood sugar, for which there is no current treatment.

The project: Utilizing a unique and rigorous human experimental model, the proposed research will attempt to gain a better understanding on how RYGB surgery improves glucose control. Dr. McLaughlin will also test a hypothesis which she believes could play an important role in the persistent low-blood sugar that is observed in some patients post-surgery.

The potential outcome: This research has the potential to identify novel molecules that could represent targets for new antidiabetic therapies. It is also an important step to identifying people at risk for low-blood sugar following RYGB and to develop postsurgical treatment strategies.

Rebekah J. Walker, PhD

Medical College of Wisconsin

Project: Lowering the impact of food insecurity in African Americans with type 2 diabetes

“I became interested in diabetes research during my doctoral training, and since that time have become passionate about addressing social determinants of health and health disparities, specifically in individuals with diabetes. Living in one of the most racially segregated cities in the nation, the burden to address the needs of individuals at particularly high risk of poor outcomes has become important to me both personally and professionally.”

The problem: Food insecurity is defined as the inability to or limitation in accessing nutritionally adequate food and may be one way to address increased diabetes risk in high-risk populations. Food insecure individuals with diabetes have worse diabetes outcomes and have more difficulty following a healthy diet compared to those who are not food insecure.

The project: Dr. Walker’s study will gather information to improve and then will test an intervention to improve blood sugar control, dietary intake, self-care management, and quality of life in food insecure African Americans with diabetes. The intervention will include weekly culturally appropriate food boxes mailed to the participants and telephone-delivered diabetes education and skills training. It will be one of the first studies focused on the unique needs of food insecure African American populations with diabetes using culturally tailored strategies.

The potential outcome: This study has the potential to guide and improve policies impacting low-income minorities with diabetes. In addition, Dr. Walker’s study will help determine if food supplementation is important in improving diabetes outcomes beyond diabetes education alone.

Give Today and Change lives!

With your support, the American Diabetes Association® can continue our lifesaving work to make breakthroughs in research and provide people with the resources they need to fight diabetes.

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Clinical Research in Type 2 Diabetes

Studies in humans aimed at the prevention, treatment, and diagnosis of Type 2 Diabetes and the mechanistic aspects of its etiology.

The Clinical Research in Type 2 Diabetes (T2D) program supports human studies across the lifespan aimed at understanding, preventing and treating T2D. This program includes clinical trials that test pharmacologic, behavioral, surgical or practice-level approaches to the treatment and/or prevention of T2D, including promoting the preservation of beta cell function. Studies may also advance the development of new surrogate markers for use in clinical trials. Studies can be designed to understand the pathophysiology of T2D, including the role of gestational diabetes and metabolic imprinting on the development of T2D, as well as factors influencing the response to treatment. The program also encompasses epidemiologic studies that improve our understanding of the natural history and pathogenesis of T2D, and the development of diagnostic criteria to distinguish type 1 and type 2 diabetes, especially in the pediatric population. The program also supports research to understand and test approaches to accelerate the translation of efficacious interventions into real-world practice and adoption; and to address health equity by reducing health disparities in the incidence and/or clinical outcomes of T2D.

NIDDK Program Staff

• Shavon Artis Dickerson, Dr.P.H., M.P.H. Health Equity and Implementation Science
• Henry B. Burch, M.D. Clinical studies utilizing existing digital health technology for the prevention and treatment of type 2 diabetes, clinical and basic science studies involving non-neoplastic disorders of the thyroid, clinical studies involving medical and novel dietary treatment of type 2 diabetes.
• Maureen Monaghan Center, Ph.D., CDCES Health Psychology, Behavioral Science, Clinical Management of Diabetes
• Minnjuan Flournoy Floyd, Ph.D., M.P.H., M.B.A. Health Disparities and Health Equity; specifically adult T2D Health Equity Research; clinical research in T2D
• Jean M. Lawrence, Sc.D., M.P.H., MSW Type 2 diabetes risk and prevention after gestational diabetes; Studies of adults with diabetes/pre-diabetes using secondary data and observational designs, and natural experiments
• Hanyu Liang, M.D., Ph.D. Hepatic Metabolism; Insulin Resistance; Type 2 Diabetes; Obesity; Bariatric Surgery
• Barbara Linder, M.D., Ph.D. Type 2 diabetes in children and youth; human studies of metabolic imprinting
• Saul Malozowski, M.D., Ph.D., M.B.A. Neuroendocrinology of hypothalamic-pituitary axis, neuropeptide signaling and receptors; hormonal regulation of bone and mineral metabolism; HIV/AIDS-associated metabolic and endocrine dysfunction
• Pamela L. Thornton, Ph.D. Health Equity and Translational Research; Centers for Diabetes Translation Research (P30) Program
• Theresa Teslovich Woo, Ph.D. Human behavior, developmental cognitive neuroscience, and brain-based mechanisms involved in obesity and diabetes

Recent Funding Opportunities

Maximizing opportunities for scientific and academic independent careers (mosaic) postdoctoral career transition award to promote diversity (k99/r00 independent clinical trial not allowed), maximizing opportunities for scientific and academic independent careers (mosaic) postdoctoral career transition award to promote diversity (k99/r00 - independent clinical trial required), building sustainable software tools for open science (r03 clinical trial not allowed), nih research software engineer (rse) award (r50 clinical trials not allowed), change of recipient organization (type 7 parent clinical trial optional), related links.

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How are qualitative methods used in diabetes research? A 30-year systematic review

Affiliations.

• 1 a Hubert Department of Global Health , Emory University , Atlanta , GA , USA.
• 2 b Department of Anthropology , Emory University , Atlanta , GA , USA.
• 3 c Department of Epidemiology , Emory University , Atlanta , GA , USA.
• PMID: 26758478
• DOI: 10.1080/17441692.2015.1120337

We aimed to describe how qualitative methods are used in global research on diabetes and identify opportunities whereby qualitative methods could further benefit our understanding of the human experience of diabetes and interventions to address it. We conducted a systematic review of National Library of Medicine, EMBASE, and Web of Science electronic databases to identify original research articles that used qualitative methods to study diabetes between 1980 and 2011. We identified 554 eligible articles and categorised these by geographic region, year of publication, study population, study design, research question, qualitative data collection methods, and journal type. Results show low use of qualitative methods in diabetes research over the past 30 years. The majority of articles (75%) reported using substantive qualitative research, while mixed-methods research has remained underutilised. Eighty-five per cent of articles reported studies conducted in North America or Europe, with few studies in developing countries. Most articles reported recruiting clinic-based populations (58%). Over half (54%) of research questions focused on patient experience and 24% on diabetes management. Qualitative methods can provide important insights about socio-cultural aspects of disease to improve disease management. However, they remain underutilised for understanding the diabetes experience, especially in Africa and Asia and amongst non-clinic populations.

Keywords: Diabetes; qualitative research; systematic review.

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