- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04489043
Exercise, Prediabetes and Diabetes After Renal Transplantation. (EXPRED)
July 24, 2020 updated by: Hospital Universitario de Canarias
This study is designed to evaluate the feasibility of exercise to reverse prediabetes after transplantation to prevent Posttransplantation Diabetes Mellitus (PTDM).
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
The hypothesis of the study is that exercise will promote the reversibility to normal glucose metabolism in patients with prediabetes and eventually reduce the incidence of PTDM in renal transplant.
The main objective of the study is to induce the reversibility of prediabetes by means of exercise.
Additionally, the secondary objectives are: (a) to evaluate the compliance of exercise (b) improvements in metabolic risk factors profile: obesity, triglycerides, blood pressure and HDL cholesterol.
Study Type
Interventional
Enrollment (Anticipated)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Raul Morales Febles
- Phone Number: +34 922678115
- Email: rmf1313@gmail.com
Study Locations
-
-
S/C De TEnerife
-
La Laguna, S/C De TEnerife, Spain, 38320
- Recruiting
- UICEC
-
Contact:
- Raul Morales Febles, Master
- Phone Number: +34 922678115
- Email: rmf1313@gmail.com
-
Contact:
- Esteban Porrini, MD., PhD
- Phone Number: +34 922678116
- Email: estebanporrini72@hotmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 110 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age > 18 years old.
- Renal transplantation: beyond 6-12 months after transplantation with stable renal function
- IFG: 100-125 mg/dl and IGT 140-199 mg/dl.
- Ability or capacity to perform exercise.
Exclusion Criteria:
- Clinical conditions that preclude the treatment with exercise i.e. clinical instability: active infection, cancer, acute cardiovascular disease, advanced renal disease, pulmonar hypertension, chronic obstructive pulmonary disease, severe reumatological disorders, arthrosis, arthritis limb amputation, etc.
- Inability to understand the protocol.
- Severe psychological disease.
- PTDM.
- Diabetes before transplantation.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Exercise and healthy life style recommendations
A planned exercise programme to test the impact of this treatment.
An Oral Glucose Tolerant Test (OGTT) at intermediate time points in order to increase the frequency and duration of aerobic exercise and eventually to add anaerobic/resistance training.
|
In the present study, renal transplant patients with proven prediabetes will do a planned exercise programme to test the impact of this treatment on the reversibility of prediabetes.
Thus, the persistance of recurrency of prediabetes assessed by an Oral Glucose Tolerant Test (OGTT) at intermediate time points (3, 6 and 9 months) will be checked in order to increase the frequency and duration of aerobic exercise and eventually to add anaerobic/resistance training.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Oral glucose tolerance test (OGTT)
Time Frame: Baseline and 3 months-12 months, every 3 months
|
After a 10-12 h overnight fast, a standard 75-g OGTT with samples taken at 0 min (glucose-insulin) and 120 minutes (glucose) will be performed at screening-baseline and after 3,6,9,12 months.
Patients must be clinically stable without conditions that could induce transient hyperglycaemia or insulin resistance, i.e. infections, acute rejection, renal failure or cardiovascular disease.
The presence of any of these conditions postponed the test for at least 3 months after full recovery.
Also, serum and urinary samples will be taken and storage at -80 degrees.
|
Baseline and 3 months-12 months, every 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Compliance
Time Frame: Baseline and 3 months-12 months, every 3 months
|
To ensure compliance, the following measures will be implemented: (a) contact by phone one time per week (at the end of the week) in the first 3 months up to the end of the study, (b) individual interview every month to reinforce lifestyle changes and follow all recommended in the exercise prescription; (c) the use of a gadget (xiaomi mi band) to see daily routines of patients and every training prescription; this analyses the time, frequency, burned calories, velocity and distance, among others, to reach the established goal by the physiotherapist.
|
Baseline and 3 months-12 months, every 3 months
|
Analitics
Time Frame: Baseline and 3 months-12 months, every 3 months
|
To evaluate the improvements in metabolic risk factors profile: obesity, triglycerides, blood pressure and HDL cholesterol.hemogram
(hematocrit, haemoglobin, white blood count), biochemist tests: creatinine, HbA1c, total, LDL and HDL cholesterol, triglycerides, uric acid, hepatic enzymes (ASAT, ALAT), levels of immunosuppression, albumin, creatinine, albuminuria, proteinuria in an isolated urinary samples.
|
Baseline and 3 months-12 months, every 3 months
|
Test the reversibility of prediabetes
Time Frame: Baseline and 3 months-12 months, every 3 months
|
There is a n exercise programme to test the impact of this treatment on the reversibility of prediabetes.
Thus, the persistance of recurrency of prediabetes assessed by an OGTT at intermediate time points (3, 6 and 9 months) will be checked in order to increase the frequency and duration of aerobic exercise and eventually to add anaerobic/resistance training.
|
Baseline and 3 months-12 months, every 3 months
|
Cardiorrespiratory fitness test
Time Frame: Baseline and 3 months-12 months, every 3 months
|
Cardiopulmonary exercise testing (CPTE) will be performed in a treadmill while collecting expired gases analysis41.
The test will begin at low work rates and gradually increased42 until indications to stop are perceived or volitional exhaustion.
The workloads selected for participants should be designed with the aim to reach the maximal effort (peak exercise) in the 8-12 minutes interval43.
During CPET maximal oxygen uptake (VO2max) is measured, the stronger predictor of CV risk.
It is generally expressed as relative (ml/kg/min)44.
|
Baseline and 3 months-12 months, every 3 months
|
Anthropometric measures
Time Frame: Baseline and 3 months-12 months, every 3 months
|
At baseline and at 3, 6, 9, 12 months: weight in kilograms, height in meters, waist circumference, hip circumference, will be measured.
Also, BMI Body mass index (BMI): weight in kilograms divided by the square of the height in meters.
The cutt-off values are the standards by the WHO97.
|
Baseline and 3 months-12 months, every 3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Study Director: Esteban Porrini, MD, PhD, Hospital Universitario de Canarias
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Garber CE, Blissmer B, Deschenes MR, Franklin BA, Lamonte MJ, Lee IM, Nieman DC, Swain DP; American College of Sports Medicine. American College of Sports Medicine position stand. Quantity and quality of exercise for developing and maintaining cardiorespiratory, musculoskeletal, and neuromotor fitness in apparently healthy adults: guidance for prescribing exercise. Med Sci Sports Exerc. 2011 Jul;43(7):1334-59. doi: 10.1249/MSS.0b013e318213fefb.
- Knowler WC, Barrett-Connor E, Fowler SE, Hamman RF, Lachin JM, Walker EA, Nathan DM; Diabetes Prevention Program Research Group. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med. 2002 Feb 7;346(6):393-403. doi: 10.1056/NEJMoa012512.
- Obesity: preventing and managing the global epidemic. Report of a WHO consultation. World Health Organ Tech Rep Ser. 2000;894:i-xii, 1-253.
- Wolfe RA, Ashby VB, Milford EL, Ojo AO, Ettenger RE, Agodoa LY, Held PJ, Port FK. Comparison of mortality in all patients on dialysis, patients on dialysis awaiting transplantation, and recipients of a first cadaveric transplant. N Engl J Med. 1999 Dec 2;341(23):1725-30. doi: 10.1056/NEJM199912023412303.
- Aktas A. Transplanted kidney function evaluation. Semin Nucl Med. 2014 Mar;44(2):129-45. doi: 10.1053/j.semnuclmed.2013.10.005.
- Womer KL, Kaplan B. Recent developments in kidney transplantation--a critical assessment. Am J Transplant. 2009 Jun;9(6):1265-71. doi: 10.1111/j.1600-6143.2009.02639.x. Epub 2009 May 13.
- Meier-Kriesche HU, Ojo AO, Port FK, Arndorfer JA, Cibrik DM, Kaplan B. Survival improvement among patients with end-stage renal disease: trends over time for transplant recipients and wait-listed patients. J Am Soc Nephrol. 2001 Jun;12(6):1293-1296. doi: 10.1681/ASN.V1261293.
- Seoane-Pillado MT, Pita-Fernandez S, Valdes-Canedo F, Seijo-Bestilleiro R, Pertega-Diaz S, Fernandez-Rivera C, Alonso-Hernandez A, Gonzalez-Martin C, Balboa-Barreiro V. Incidence of cardiovascular events and associated risk factors in kidney transplant patients: a competing risks survival analysis. BMC Cardiovasc Disord. 2017 Mar 7;17(1):72. doi: 10.1186/s12872-017-0505-6.
- Dahle DO, Grotmol T, Leivestad T, Hartmann A, Midtvedt K, Reisaeter AV, Mjoen G, Pihlstrom HK, Naess H, Holdaas H. Association Between Pretransplant Cancer and Survival in Kidney Transplant Recipients. Transplantation. 2017 Oct;101(10):2599-2605. doi: 10.1097/TP.0000000000001659.
- Viecelli AK, Lim WH, Macaskill P, Chapman JR, Craig JC, Clayton P, Cohney S, Carroll R, Wong G. Cancer-Specific and All-Cause Mortality in Kidney Transplant Recipients With and Without Previous Cancer. Transplantation. 2015 Dec;99(12):2586-92. doi: 10.1097/TP.0000000000000760.
- Wauters RP, Cosio FG, Suarez Fernandez ML, Kudva Y, Shah P, Torres VE. Cardiovascular consequences of new-onset hyperglycemia after kidney transplantation. Transplantation. 2012 Aug 27;94(4):377-82. doi: 10.1097/TP.0b013e3182584831.
- Sharif A, Hecking M, de Vries AP, Porrini E, Hornum M, Rasoul-Rockenschaub S, Berlakovich G, Krebs M, Kautzky-Willer A, Schernthaner G, Marchetti P, Pacini G, Ojo A, Takahara S, Larsen JL, Budde K, Eller K, Pascual J, Jardine A, Bakker SJ, Valderhaug TG, Jenssen TG, Cohney S, Saemann MD. Proceedings from an international consensus meeting on posttransplantation diabetes mellitus: recommendations and future directions. Am J Transplant. 2014 Sep;14(9):1992-2000. doi: 10.1111/ajt.12850. Epub 2014 Aug 6.
- Rayburn WF. Diagnosis and classification of diabetes mellitus: highlights from the American Diabetes Association. J Reprod Med. 1997 Sep;42(9):585-6. No abstract available.
- Porrini EL, Diaz JM, Moreso F, Delgado Mallen PI, Silva Torres I, Ibernon M, Bayes-Genis B, Benitez-Ruiz R, Lampreabe I, Lauzurrica R, Osorio JM, Osuna A, Dominguez-Rollan R, Ruiz JC, Jimenez-Sosa A, Gonzalez-Rinne A, Marrero-Miranda D, Macia M, Garcia J, Torres A. Clinical evolution of post-transplant diabetes mellitus. Nephrol Dial Transplant. 2016 Mar;31(3):495-505. doi: 10.1093/ndt/gfv368. Epub 2015 Nov 3.
- Hagen M, Hjelmesaeth J, Jenssen T, Morkrid L, Hartmann A. A 6-year prospective study on new onset diabetes mellitus, insulin release and insulin sensitivity in renal transplant recipients. Nephrol Dial Transplant. 2003 Oct;18(10):2154-9. doi: 10.1093/ndt/gfg338.
- Torres A, Hernandez D, Moreso F, Seron D, Burgos MD, Pallardo LM, Kanter J, Diaz Corte C, Rodriguez M, Diaz JM, Silva I, Valdes F, Fernandez-Rivera C, Osuna A, Gracia Guindo MC, Gomez Alamillo C, Ruiz JC, Marrero Miranda D, Perez-Tamajon L, Rodriguez A, Gonzalez-Rinne A, Alvarez A, Perez-Carreno E, de la Vega Prieto MJ, Henriquez F, Gallego R, Salido E, Porrini E. Randomized Controlled Trial Assessing the Impact of Tacrolimus Versus Cyclosporine on the Incidence of Posttransplant Diabetes Mellitus. Kidney Int Rep. 2018 Jul 11;3(6):1304-1315. doi: 10.1016/j.ekir.2018.07.009. eCollection 2018 Nov.
- Hur KY, Kim MS, Kim YS, Kang ES, Nam JH, Kim SH, Nam CM, Ahn CW, Cha BS, Kim SI, Lee HC. Risk factors associated with the onset and progression of posttransplantation diabetes in renal allograft recipients. Diabetes Care. 2007 Mar;30(3):609-15. doi: 10.2337/dc06-1277.
- Porrini E, Moreno JM, Osuna A, Benitez R, Lampreabe I, Diaz JM, Silva I, Dominguez R, Gonzalez-Cotorruelo J, Bayes B, Lauzurica R, Ibernon M, Moreso F, Delgado P, Torres A. Prediabetes in patients receiving tacrolimus in the first year after kidney transplantation: a prospective and multicenter study. Transplantation. 2008 Apr 27;85(8):1133-8. doi: 10.1097/TP.0b013e31816b16bd.
- Valderhaug TG, Jenssen T, Hartmann A, Midtvedt K, Holdaas H, Reisaeter AV, Hjelmesaeth J. Fasting plasma glucose and glycosylated hemoglobin in the screening for diabetes mellitus after renal transplantation. Transplantation. 2009 Aug 15;88(3):429-34. doi: 10.1097/TP.0b013e3181af1f53.
- Luan FL, Langewisch E, Ojo A. Metabolic syndrome and new onset diabetes after transplantation in kidney transplant recipients. Clin Transplant. 2010 Nov-Dec;24(6):778-83. doi: 10.1111/j.1399-0012.2009.01194.x.
- Lv C, Chen M, Xu M, Xu G, Zhang Y, He S, Xue M, Gao J, Yu M, Gao X, Zhu T. Influencing factors of new-onset diabetes after a renal transplant and their effects on complications and survival rate. PLoS One. 2014 Jun 9;9(6):e99406. doi: 10.1371/journal.pone.0099406. eCollection 2014.
- Al-Ghareeb SM, El-Agroudy AE, Al Arrayed SM, Al Arrayed A, Alhellow HA. Risk factors and outcomes of new-onset diabetes after transplant: single-centre experience. Exp Clin Transplant. 2012 Oct;10(5):458-65. doi: 10.6002/ect.2012.0063. Epub 2012 Aug 29.
- Woodward RS, Schnitzler MA, Baty J, Lowell JA, Lopez-Rocafort L, Haider S, Woodworth TG, Brennan DC. Incidence and cost of new onset diabetes mellitus among U.S. wait-listed and transplanted renal allograft recipients. Am J Transplant. 2003 May;3(5):590-8. doi: 10.1034/j.1600-6143.2003.00082.x.
- Sharif A, Baboolal K. Risk factors for new-onset diabetes after kidney transplantation. Nat Rev Nephrol. 2010 Jul;6(7):415-23. doi: 10.1038/nrneph.2010.66. Epub 2010 May 25.
- Montori VM, Basu A, Erwin PJ, Velosa JA, Gabriel SE, Kudva YC. Posttransplantation diabetes: a systematic review of the literature. Diabetes Care. 2002 Mar;25(3):583-92. doi: 10.2337/diacare.25.3.583.
- Pan XR, Li GW, Hu YH, Wang JX, Yang WY, An ZX, Hu ZX, Lin J, Xiao JZ, Cao HB, Liu PA, Jiang XG, Jiang YY, Wang JP, Zheng H, Zhang H, Bennett PH, Howard BV. Effects of diet and exercise in preventing NIDDM in people with impaired glucose tolerance. The Da Qing IGT and Diabetes Study. Diabetes Care. 1997 Apr;20(4):537-44. doi: 10.2337/diacare.20.4.537.
- Karamanakos G, Costa-Pinel B, Gilis-Januszewska A, Velickiene D, Barrio-Torrell F, Cos-Claramunt X, Mestre-Miravet S, Piwonska-Solska B, Hubalewska-Dydejczyk A, Tuomilehto J, Liatis S, Makrilakis K. The effectiveness of a community-based, type 2 diabetes prevention programme on health-related quality of life. The DE-PLAN study. PLoS One. 2019 Oct 11;14(10):e0221467. doi: 10.1371/journal.pone.0221467. eCollection 2019.
- Didsbury M, McGee RG, Tong A, Craig JC, Chapman JR, Chadban S, Wong G. Exercise training in solid organ transplant recipients: a systematic review and meta-analysis. Transplantation. 2013 Mar 15;95(5):679-87. doi: 10.1097/TP.0b013e31827a3d3e.
- Karelis AD, Hebert MJ, Rabasa-Lhoret R, Rakel A. Impact of Resistance Training on Factors Involved in the Development of New-Onset Diabetes After Transplantation in Renal Transplant Recipients: An Open Randomized Pilot Study. Can J Diabetes. 2016 Oct;40(5):382-388. doi: 10.1016/j.jcjd.2015.08.014. Epub 2015 Dec 2.
- Sharif A, Moore R, Baboolal K. Influence of lifestyle modification in renal transplant recipients with postprandial hyperglycemia. Transplantation. 2008 Feb 15;85(3):353-8. doi: 10.1097/TP.0b013e3181605ebf.
- Abstracts of the 50th ERA-EDTA (European Renal Association-European Dialysis and Transplant Association) Congress. May 18-21, 2013. Istanbul, Turkey. Nephrol Dial Transplant. 2013 May;28 Suppl 1:i1-553. No abstract available.
- Dominguez-Rodriguez A, Abreu-Gonzalez P, Mendez-Vargas C, Martin-Cabeza M, Gonzalez J, Garcia-Baute Mdel C, de la Rosa A, Laynez-Cerdena I. Ventilatory efficiency predicts adverse cardiovascular events in asymptomatic patients with severe aortic stenosis and preserved ejection fraction. Int J Cardiol. 2014 Dec 20;177(3):1116-8. doi: 10.1016/j.ijcard.2014.08.073. Epub 2014 Aug 16. No abstract available.
- Guazzi M, Arena R, Halle M, Piepoli MF, Myers J, Lavie CJ. 2016 Focused Update: Clinical Recommendations for Cardiopulmonary Exercise Testing Data Assessment in Specific Patient Populations. Circulation. 2016 Jun 14;133(24):e694-711. doi: 10.1161/CIR.0000000000000406. Epub 2016 May 2.
- Balady GJ, Arena R, Sietsema K, Myers J, Coke L, Fletcher GF, Forman D, Franklin B, Guazzi M, Gulati M, Keteyian SJ, Lavie CJ, Macko R, Mancini D, Milani RV; American Heart Association Exercise, Cardiac Rehabilitation, and Prevention Committee of the Council on Clinical Cardiology; Council on Epidemiology and Prevention; Council on Peripheral Vascular Disease; Interdisciplinary Council on Quality of Care and Outcomes Research. Clinician's Guide to cardiopulmonary exercise testing in adults: a scientific statement from the American Heart Association. Circulation. 2010 Jul 13;122(2):191-225. doi: 10.1161/CIR.0b013e3181e52e69. Epub 2010 Jun 28. No abstract available.
- Fauziana R, Jeyagurunathan A, Abdin E, Vaingankar J, Sagayadevan V, Shafie S, Sambasivam R, Chong SA, Subramaniam M. Body mass index, waist-hip ratio and risk of chronic medical condition in the elderly population: results from the Well-being of the Singapore Elderly (WiSE) Study. BMC Geriatr. 2016 Jun 18;16:125. doi: 10.1186/s12877-016-0297-z.
- Nishida C, Ko GT, Kumanyika S. Body fat distribution and noncommunicable diseases in populations: overview of the 2008 WHO Expert Consultation on Waist Circumference and Waist-Hip Ratio. Eur J Clin Nutr. 2010 Jan;64(1):2-5. doi: 10.1038/ejcn.2009.139. Epub 2009 Nov 25.
- Bushman B. Promoting exercise as medicine for prediabetes and prehypertension. Curr Sports Med Rep. 2014 Jul-Aug;13(4):233-9. doi: 10.1249/JSR.0000000000000066.
- Wahid A, Manek N, Nichols M, Kelly P, Foster C, Webster P, Kaur A, Friedemann Smith C, Wilkins E, Rayner M, Roberts N, Scarborough P. Quantifying the Association Between Physical Activity and Cardiovascular Disease and Diabetes: A Systematic Review and Meta-Analysis. J Am Heart Assoc. 2016 Sep 14;5(9):e002495. doi: 10.1161/JAHA.115.002495.
- Colberg SR, Sigal RJ, Yardley JE, Riddell MC, Dunstan DW, Dempsey PC, Horton ES, Castorino K, Tate DF. Physical Activity/Exercise and Diabetes: A Position Statement of the American Diabetes Association. Diabetes Care. 2016 Nov;39(11):2065-2079. doi: 10.2337/dc16-1728. No abstract available.
- Thompson PD, Arena R, Riebe D, Pescatello LS; American College of Sports Medicine. ACSM's new preparticipation health screening recommendations from ACSM's guidelines for exercise testing and prescription, ninth edition. Curr Sports Med Rep. 2013 Jul-Aug;12(4):215-7. doi: 10.1249/JSR.0b013e31829a68cf. No abstract available.
- Gordon BA, Benson AC, Bird SR, Fraser SF. Resistance training improves metabolic health in type 2 diabetes: a systematic review. Diabetes Res Clin Pract. 2009 Feb;83(2):157-75. doi: 10.1016/j.diabres.2008.11.024. Epub 2009 Jan 9.
- Ramachandran A, Snehalatha C, Mary S, Mukesh B, Bhaskar AD, Vijay V; Indian Diabetes Prevention Programme (IDPP). The Indian Diabetes Prevention Programme shows that lifestyle modification and metformin prevent type 2 diabetes in Asian Indian subjects with impaired glucose tolerance (IDPP-1). Diabetologia. 2006 Feb;49(2):289-97. doi: 10.1007/s00125-005-0097-z. Epub 2006 Jan 4.
- Kosaka K, Noda M, Kuzuya T. Prevention of type 2 diabetes by lifestyle intervention: a Japanese trial in IGT males. Diabetes Res Clin Pract. 2005 Feb;67(2):152-62. doi: 10.1016/j.diabres.2004.06.010.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 5, 2019
Primary Completion (Actual)
December 5, 2019
Study Completion (Anticipated)
October 1, 2021
Study Registration Dates
First Submitted
July 15, 2020
First Submitted That Met QC Criteria
July 24, 2020
First Posted (Actual)
July 28, 2020
Study Record Updates
Last Update Posted (Actual)
July 28, 2020
Last Update Submitted That Met QC Criteria
July 24, 2020
Last Verified
July 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EXPRED
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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