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Clinical Trial Protocol for Porcine Islet Xenotransplantation in South Korea
Byung-Joon Kim, Jun-Seop Shin, Byoung-Hoon Min, Jong-Min Kim, Chung-Gyu Park, Hee-Jung Kang, Eung Soo Hwang, Won-Woo Lee, Jung-Sik Kim, Hyun Je Kim, Iov Kwon, Jae Sung Kim, Geun Soo Kim, Joonho Moon, Du Yeon Shin, Bumrae Cho, Heung-Mo Yang, Sung Joo Kim, Kwang-Won Kim
Diabetes Metab J. 2024;48(6):1160-1168.   Published online May 21, 2024
DOI: https://doi.org/10.4093/dmj.2023.0260
  • 2,197 View
  • 135 Download
AbstractAbstract PDFSupplementary MaterialPubReader   ePub   
Background
Islet transplantation holds promise for treating selected type 1 diabetes mellitus patients, yet the scarcity of human donor organs impedes widespread adoption. Porcine islets, deemed a viable alternative, recently demonstrated successful longterm survival without zoonotic risks in a clinically relevant pig-to-non-human primate islet transplantation model. This success prompted the development of a clinical trial protocol for porcine islet xenotransplantation in humans.
Methods
A single-center, open-label clinical trial initiated by the sponsor will assess the safety and efficacy of porcine islet transplantation for diabetes patients at Gachon Hospital. The protocol received approval from the Gachon Hospital Institutional Review Board (IRB) and the Korean Ministry of Food and Drug Safety (MFDS) under the Investigational New Drug (IND) process. Two diabetic patients, experiencing inadequate glycemic control despite intensive insulin treatment and frequent hypoglycemic unawareness, will be enrolled. Participants and their family members will engage in deliberation before xenotransplantation during the screening period. Each patient will receive islets isolated from designated pathogen-free pigs. Immunosuppressants and systemic infection prophylaxis will follow the program schedule. The primary endpoint is to confirm the safety of porcine islets in patients, and the secondary endpoint is to assess whether porcine islets can reduce insulin dose and the frequency of hypoglycemic unawareness.
Conclusion
A clinical trial protocol adhering to global consensus guidelines for porcine islet xenotransplantation is presented, facilitating streamlined implementation of comparable human trials worldwide.
Basic Research
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Notch1 Has an Important Role in β-Cell Mass Determination and Development of Diabetes
Young Sil Eom, A-Ryeong Gwon, Kyung Min Kwak, Jin-Young Youn, Heekyoung Park, Kwang-Won Kim, Byung-Joon Kim
Diabetes Metab J. 2021;45(1):86-96.   Published online February 26, 2020
DOI: https://doi.org/10.4093/dmj.2019.0160
  • 7,336 View
  • 205 Download
  • 9 Web of Science
  • 8 Crossref
Graphical AbstractGraphical Abstract AbstractAbstract PDFSupplementary MaterialPubReader   ePub   
Background

Notch signaling pathway plays an important role in regulating pancreatic endocrine and exocrine cell fate during pancreas development. Notch signaling is also expressed in adult pancreas. There are few studies on the effect of Notch on adult pancreas. Here, we investigated the role of Notch in islet mass and glucose homeostasis in adult pancreas using Notch1 antisense transgenic (NAS).

Methods

Western blot analysis was performed for the liver of 8-week-old male NAS mice. We also conducted an intraperitoneal glucose tolerance test (IPGTT) and intraperitoneal insulin tolerance test in 8-week-old male NAS mice and male C57BL/6 mice (control). Morphologic observation of pancreatic islet and β-cell was conducted in two groups. Insulin secretion capacity in islets was measured by glucose-stimulated insulin secretion (GSIS) and perifusion.

Results

NAS mice showed higher glucose levels and lower insulin secretion in IPGTT than the control mice. There was no significant difference in insulin resistance. Total islet and β-cell masses were decreased in NAS mice. The number of large islets (≥250 µm) decreased while that of small islets (<250 µm) increased. Reduced insulin secretion was observed in GSIS and perifusion. Neurogenin3, neurogenic differentiation, and MAF bZIP transcription factor A levels increased in NAS mice.

Conclusion

Our study provides that Notch1 inhibition decreased insulin secretion and decreased islet and β-cell masses. It is thought that Notch1 inhibition suppresses islet proliferation and induces differentiation of small islets. In conclusion, Notch signaling pathway may play an important role in β-cell mass determination and diabetes.

Citations

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Review
Complications
Diabetes and Cancer: Cancer Should Be Screened in Routine Diabetes Assessment
Sunghwan Suh, Kwang-Won Kim
Diabetes Metab J. 2019;43(6):733-743.   Published online December 23, 2019
DOI: https://doi.org/10.4093/dmj.2019.0177
  • 10,302 View
  • 287 Download
  • 105 Web of Science
  • 113 Crossref
AbstractAbstract PDFPubReader   

Cancer incidence appears to be increased in both type 1 and type 2 diabetes mellitus (DM). DM represents a risk factor for cancer, particularly hepatocellular, hepatobiliary, pancreas, breast, ovarian, endometrial, and gastrointestinal cancers. In addition, there is evidence showing that DM is associated with increased cancer mortality. Common risk factors such as age, obesity, physical inactivity and smoking may contribute to increased cancer risk in patients with DM. Although the mechanistic process that may link diabetes to cancer is not completely understood yet, biological mechanisms linking DM and cancer are hyperglycemia, hyperinsulinemia, increased bioactivity of insulin-like growth factor 1, oxidative stress, dysregulations of sex hormones, and chronic inflammation. However, cancer screening rate is significantly lower in people with DM than that in people without diabetes. Evidence from previous studies suggests that some medications used to treat DM are associated with either increased or reduced risk of cancer. However, there is no strong evidence supporting the association between the use of anti-hyperglycemic medication and specific cancer. In conclusion, all patients with DM should be undergo recommended age- and sex appropriate cancer screenings to promote primary prevention and early detection. Furthermore, cancer should be screened in routine diabetes assessment.

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Original Articles
Effectiveness of 3-Day Continuous Glucose Monitoring for Improving Glucose Control in Type 2 Diabetic Patients in Clinical Practice
Soo Kyoung Kim, Hye Jeong Kim, Taehun Kim, Kyu Yeon Hur, Sun Wook Kim, Moon-Kyu Lee, Yong-Ki Min, Kwang-Won Kim, Jae Hoon Chung, Jae Hyeon Kim
Diabetes Metab J. 2014;38(6):449-455.   Published online December 15, 2014
DOI: https://doi.org/10.4093/dmj.2014.38.6.449
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AbstractAbstract PDFPubReader   
Background

The aim of this study was to investigate whether adjusting diabetic treatment regimens according to the information obtained from a continuous glucose monitoring system (CGMS) might lead to improved glycemic control in patients with type 2 diabetes.

Methods

We reviewed the medical charts of 172 patients who used the CGMS for 1 year starting in December 2008 and the records of 1,500 patients who visited their regular outpatient clinics during December 2008. Of these patients, a total of 65 CGMS patients and 301 regular outpatients (control group) were enrolled in the study after propensity score matching. There were no differences in baseline glycated hemoglobin (HbA1c), age, and duration of diabetes between the CGMS and the control groups after propensity score matching. The changes in the HbA1c levels from baseline to 6 months were calculated.

Results

The CGMS group showed a significant improvement in the HbA1c level compared to the control group at 3 months (7.9%±1.6% vs. 7.4%±1.2%, P=0.001) and at 6 months (7.4%±1.2% vs. 7.9%±1.6%, P=0.010). There were significant differences in the treatment modality changes between the CGMS group and the control group.

Conclusion

Using a 3-day CGMS was advantageous for improving glucose control in patients with type 2 diabetes and may help these patients to optimize glycemic control in clinical practice.

Citations

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Education as Prescription for Patients with Type 2 Diabetes Mellitus: Compliance and Efficacy in Clinical Practice
Mi Yeon Kim, Sunghwan Suh, Sang-Man Jin, Se Won Kim, Ji Cheol Bae, Kyu Yeon Hur, Sung Hye Kim, Mi Yong Rha, Young Yun Cho, Myung-Shik Lee, Moon Kyu Lee, Kwang-Won Kim, Jae Hyeon Kim
Diabetes Metab J. 2012;36(6):452-459.   Published online December 12, 2012
DOI: https://doi.org/10.4093/dmj.2012.36.6.452
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AbstractAbstract PDFPubReader   
Background

Diabetes self-management education has an important role in diabetes management. The efficacy of education has been proven in several randomized trials. However, the status of diabetes education programs in real Korean clinical practice has not yet been evaluated in terms of patient compliance with the education prescription.

Methods

We retrospectively analyzed clinical and laboratory data from all patients who were ordered to undergo diabetes education during 2009 at Samsung Medical Center, Seoul, Korea (n=2,291). After excluding ineligible subjects, 588 patients were included in the analysis.

Results

Among the 588 patients, 433 received education. The overall compliance rate was 73.6%, which was significantly higher in the subjects with a short duration or living in a rural area compared to those with a long duration (85.0% vs. 65.1%, respectively; P<0.001) or living in an urban area (78.2% vs. 70.4%, respectively; P=0.037). The hemoglobin A1c decreased greater in the compliant group (from 7.84±1.54 at baseline to 6.79±1.06 at 3 months and 6.97±1.20 at 12 months after prescription in the compliant group vs. from 7.74±1.25 to 7.14±1.02 and 7.24±1.24 in the non-compliant group; P=0.001). The decrease in hemoglobin A1c was greater in the subjects with a short duration (P=0.032).

Conclusion

In our study a large percent of patients refuse to get education despite having a prescription from their physician. This refusal rate was higher in the patients with long-standing diabetes or in urban residence. Furthermore, education was more effective in patients with a short duration of diabetes in clinical practice.

Citations

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Smaller Mean LDL Particle Size and Higher Proportion of Small Dense LDL in Korean Type 2 Diabetic Patients
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Diabetes Metab J. 2011;35(5):536-542.   Published online October 31, 2011
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AbstractAbstract PDFPubReader   
Background

Small dense low density lipoprotein (sdLDL) has recently emerged as an important risk factor of coronary heart disease.

Methods

The mean LDL particle size was measured in 203 patients with type 2 diabetes mellitus (T2DM) and 212 matched subjects without diabetes using polyacrylamide tube gel electrophoresis. Major vascular complications were defined as stroke, angiographically-documented coronary artery disease or a myocardial infarction. Peripheral vascular stenosis, carotid artery stenosis (≥50% in diameter) or carotid artery plaque were considered minor vascular complications. Overall vascular complications included both major and minor vascular complications.

Results

Diabetic patients had significantly smaller mean-LDL particle size (26.32 nm vs. 26.49 nm) and a higher percentage of sdLDL to total LDL compared to those of subjects without diabetes (21.39% vs. 6.34%). The independent predictors of sdLDL in this study were serum triglyceride level and body mass index (odds ratio [OR], 1.020 with P<0.001 and OR 1.152 with P<0.027, respectively). However, no significant correlations were found between sdLDL and major vascular complications (P=0.342), minor vascular complications (P=0.573) or overall vascular complications (P=0.262) in diabetic subjects.

Conclusion

Diabetic patients had a smaller mean-LDL particle size and higher proportion of sdLDL compared to those of subjects without diabetes. Obese diabetic patients with hypertriglyceridemia have an increased risk for atherogenic small dense LDL. However, we could not verify an association between LDL particle size and vascular complications in this study.

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Review
Diabetes and Cancer: Is Diabetes Causally Related to Cancer?
Sunghwan Suh, Kwang-Won Kim
Diabetes Metab J. 2011;35(3):193-198.   Published online June 30, 2011
DOI: https://doi.org/10.4093/dmj.2011.35.3.193
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AbstractAbstract PDFPubReader   

Diabetes mellitus is a serious and growing health problem worldwide and is associated with severe acute and chronic complications. Moreover, epidemiologic evidence suggests that people with diabetes are at significantly higher risk for many forms of cancer. Several studies indicate an association between diabetes and the risk of liver, pancreas, endometrium, colon/rectum, breast, and bladder cancer. Mortality is also moderately increased in subjects with diabetes. Common risk factors such as age, obesity, physical inactivity and smoking may contribute to increased cancer risk in diabetic patients. Hyperinsulinemia most likely favors cancer in diabetic patients as insulin is a growth factor with pre-eminent metabolic as well as mitogenic effects, and its action in malignant cells is favored by mechanisms acting at both the receptor and post-receptor level. The effect of diabetes treatment drugs, aside from metformin, on cancer is not conclusive. In order to fight the perfect storm of diabetes and cancer, strategies to promote primary prevention and early detection of these conditions are urgently needed.

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Original Article
The Relationship between Lung Function and Metabolic Syndrome in Obese and Non-Obese Korean Adult Males
Soo Kyoung Kim, Kyu Yeon Hur, Yoon Ho Choi, Sun Wook Kim, Jae Hoon Chung, Hee Kyung Kim, Moon-Kyu Lee, Yong-Ki Min, Kwang-Won Kim, Jae Hyeon Kim
Korean Diabetes J. 2010;34(4):253-260.   Published online August 31, 2010
DOI: https://doi.org/10.4093/kdj.2010.34.4.253
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AbstractAbstract PDFPubReader   
Background

The existence of an association between lung function and metabolic syndrome (MetS) has been debated in cases involving non-obese subjects. To address this debate, we performed a cross-sectional study to investigate the association between lung function and MetS in both obese and non-obese populations.

Methods

The present study consisted of a total of 1,951 Korean male subjects. In this study group, we investigated relationships between lung function and MetS risk factors such as fasting serum glucose, systolic blood pressure (SBP), insulin resistance index, waist circumference (WC), and hemoglobin A1C level.

Results

Forced vital capacity (FVC) values were significantly lower in the MetS group compared with those of the non-MetS group. In both non-obese (body mass index [BMI] < 25 kg/m2) and obese subjects (BMI ≥ 25 kg/m2), fasting serum glucose, hemoglobin A1C level, insulin resistance index, SBP, WC, and the prevalences of diabetes and MetS were significantly higher in subjects in the lowest FVC quartile compared with those in the highest FVC quartile. Odds ratios for the presence of MetS risk factors, after adjusting for age and height, ranged from 1.21 to 1.39 (P < 0.01) for a one standard deviation decrease in FVC.

Conclusion

The results of our study suggest that decreased vital capacity in Korean adult male subjects is associated with MetS, irrespective of obesity.

Citations

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