Diabetes MellitusEXPREDNCT04489043
Exercise, Prediabetes and Diabetes After Renal Transplantation.
A study testing Exercise and healthy lifestyle recommendations in people with Diabetes Mellitus, run by Hospital Universitario de Canarias at 1 site in Spain.
Trial summary
This study is designed to evaluate the feasibility of exercise to reverse prediabetes after transplantation to prevent Posttransplantation Diabetes Mellitus (PTDM). Read more about this study
- Who is it for?
- Ages 18 to 110 years
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Exercise and healthy lifestyle recommendations
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 5 Sep 2019to 1 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
UICEC
San Cristóbal de La Laguna, S/C de TEnerife, 38320
Raul Morales Febles, Master, +34 922678115, rmf1313@gmail.com
Esteban Porrini, MD., PhD, +34 922678116, estebanporrini72@hotmail.com
About this study
This study is designed to evaluate the feasibility of exercise to reverse prediabetes after transplantation to prevent Posttransplantation Diabetes Mellitus (PTDM).
Read the 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.
- Conditions
- Diabetes Mellitus
- Being tested
- Exercise and healthy lifestyle recommendations
- Keywords
- PreDiabetes, Exercise, Late post transplant Diabetes Mellitus (PTDM), Renal transplantation
- Medical subject headings
- Diabetes Mellitus, Prediabetic State, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise and healthy lifestyle recommendationsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Exercise and healthy life style recommendations | Experimental | 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. Receives: Other: Exercise and healthy lifestyle recommendations |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 3 months-12 months, every 3 months
Secondary outcomes (5)
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.
Measured: Baseline and 3 months-12 months, every 3 months
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.
Measured: Baseline and 3 months-12 months, every 3 months
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.
Measured: Baseline and 3 months-12 months, every 3 months
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.
Measured: Baseline and 3 months-12 months, every 3 months
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.
Measured: Baseline and 3 months-12 months, every 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2020
- Study start5 Sep 2019
- Primary completion5 Dec 2019
- Study completion1 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (44)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Patients with prediabetes beyond 12 months after transplantation will be included. Prediabetes will be diagnosed based on fasting glucose levels and oral glucose tolerance tests (OGTT). Patients will be treated with a stepped training intervention, starting with an aerobic exercise training (brisk walking, swimming and cycling) 5 times per week, 30 min/day. Aerobic exercise training will gradually increase to 60 min/day or in combination with anaerobic exercise training in case of persistent prediabetes. The reversibility/persistence of prediabetes will be measured with fasting glucose and OGTTs at every 3 months.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario de Canarias
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Responsible party
- Sponsor
- Investigators
- Esteban Porrini, MD, PhD, Study director, Hospital Universitario de Canarias
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04489043
- Sponsor's protocol ID
- EXPRED
- Acronym
- EXPRED
- Status last verified
- Jul 2020
- First submitted
- 15 Jul 2020
- Last updated
- 28 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Aktas A. Transplanted kidney function evaluation. Semin Nucl Med. 2014 Mar;44(2):129-45. doi: 10.1053/j.semnuclmed.2013.10.005.
PubMed 24484750Womer 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.
PubMed 19459815Wolfe 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.
PubMed 10580071Meier-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.
PubMed 11373354Seoane-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.
PubMed 28270107Dahle 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.
PubMed 28207636Viecelli 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.
PubMed 26102612Wauters 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.
PubMed 22820698Sharif 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.
PubMed 25307034Rayburn 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.
PubMed 9336756Porrini 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.
PubMed 26538615Hagen 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.
PubMed 13679495Torres 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.
PubMed 30450457Hur 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.
PubMed 17327329Porrini 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.
PubMed 18431233
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise, Prediabetes and Diabetes After Renal Transplantation.
- ClinicalTrials.gov ID
- NCT04489043
- Acronym / sponsor ID
- EXPRED / EXPRED
- Conditions
- Diabetes Mellitus
- Keywords
- PreDiabetes, Exercise, Late post transplant Diabetes Mellitus (PTDM), Renal transplantation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hospital Universitario de CanariasUniversity, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Study start
- 5 Sep 2019 (actual)
- Primary completion
- 5 Dec 2019 (actual)
- Study completion
- 1 Oct 2021 (estimated)
- First posted
- 28 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to evaluate the feasibility of exercise to reverse prediabetes after transplantation to prevent Posttransplantation Diabetes Mellitus (PTDM).
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients with prediabetes beyond 12 months after transplantation will be included. Prediabetes will be diagnosed based on fasting glucose levels and oral glucose tolerance tests (OGTT). Patients will be treated with a stepped training intervention, starting with an aerobic exercise training (brisk walking, swimming and cycling) 5 times per week, 30 min/day. Aerobic exercise training will gradually increase to 60 min/day or in combination with anaerobic exercise training in case of persistent prediabetes. The reversibility/persistence of prediabetes will be measured with fasting glucose and OGTTs at every 3 months.
| Arm | Type | Receives |
|---|---|---|
| Exercise and healthy life style recommendations | Experimental | Other: Exercise and healthy lifestyle recommendationsA 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. |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise and healthy lifestyle recommendationsIn 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. | Other | Exercise and healthy life style recommendations |
Primary outcome
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.
5 secondary outcomes
Compliance
Time frame: Baseline and 3 months-12 months, every 3 months
Analitics
Time frame: 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
Cardiorrespiratory fitness test
Time frame: Baseline and 3 months-12 months, every 3 months
Anthropometric measures
Time frame: Baseline and 3 months-12 months, every 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2020.
- Results publication: PubMed 24484750Aktas A. Transplanted kidney function evaluation. Semin Nucl Med. 2014 Mar;44(2):129-45. doi: 10.1053/j.semnuclmed.2013.10.005.
- Results publication: PubMed 19459815Womer 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.
- Results publication: PubMed 10580071Wolfe 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.
- Results publication: PubMed 11373354Meier-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.
- Results publication: PubMed 28270107Seoane-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.
- Results publication: PubMed 28207636Dahle 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.
- Results publication: PubMed 26102612Viecelli 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.
- Results publication: PubMed 22820698Wauters 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.
- Results publication: PubMed 25307034Sharif 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.
- Results publication: PubMed 9336756Rayburn 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.
- Results publication: PubMed 26538615Porrini 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.
- Results publication: PubMed 13679495Hagen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Esteban Porrini, MD, PhD study director
Hospital Universitario de Canarias
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise and healthy lifestyle recommendations in people with Diabetes Mellitus, run by Hospital Universitario de Canarias at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Raul Morales Febles (+34 922678115, rmf1313@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oral glucose tolerance test (OGTT) (time frame: Baseline and 3 months-12 months, every 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04489043, which also lists 44 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2020.