Exercise, Prediabetes and Diabetes After Renal Transplantation.

Diabetes Mellitus Clinical Trial

— EXPRED  

Official title:

Exercise, Prediabetes and Diabetes After Renal Transplantation.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04489043
• Other study ID #: EXPRED
• Status: Recruiting
• Phase: N/A
• Start date: September 5, 2019
• Est. completion date: October 1, 2021

Study information

• Verified date: July 2020
• Source: Hospital Universitario de Canarias
• Contact: Raul Morales Febles
• Phone: +34 922678115
• Email: rmf1313[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is designed to evaluate the feasibility of exercise to reverse prediabetes after transplantation to prevent Posttransplantation Diabetes Mellitus (PTDM).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: October 1, 2021
• Est. primary completion date: December 5, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 110 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Glucose Intolerance
• Prediabetic State

Intervention

Other:
• Exercise and healthy lifestyle recommendations
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.

Locations

Country	Name	City	State
Spain	UICEC	La Laguna	S/C De TEnerife

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Universitario de Canarias	Instituto de Salud Carlos III

Country where clinical trial is conducted

Spain, 

References & Publications (43)

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. — View Citation

Aktas A. Transplanted kidney function evaluation. Semin Nucl Med. 2014 Mar;44(2):129-45. doi: 10.1053/j.semnuclmed.2013.10.005. Review. — View Citation

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. — View Citation

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 Coun — View Citation

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. Review. — View Citation

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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. Review. — View Citation

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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. Review. — View Citation

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.0000 — View Citation

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. — View Citation

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. — View Citation

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 — View Citation

Karelis AD, Hébert MJ, Rabasa-Lhoret R, Räkel 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 — View Citation

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):393-40 — View Citation

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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. — View Citation

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 — View Citation

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):1293-6. — View Citation

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. Review. — View Citation

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. Epu — View Citation

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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 — View Citation

Porrini E, Moreno JM, Osuna A, Benitez R, Lampreabe I, Diaz JM, Silva I, Domínguez 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 transp — View Citation

Porrini EL, Díaz JM, Moreso F, Delgado Mallén PI, Silva Torres I, Ibernon M, Bayés-Genís B, Benitez-Ruiz R, Lampreabe I, Lauzurrica R, Osorio JM, Osuna A, Domínguez-Rollán R, Ruiz JC, Jiménez-Sosa A, González-Rinne A, Marrero-Miranda D, Macía M, García J, — View Citation

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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 — View Citation

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: 10.109 — View Citation

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* Note: There are 43 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oral glucose tolerance test (OGTT)	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	Compliance	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
Secondary	Analitics	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
Secondary	Test the reversibility of prediabetes	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
Secondary	Cardiorrespiratory fitness test	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
Secondary	Anthropometric measures	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