NCT02883777|Unknown
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Sponsor study identifier
interventional
120
1 country
1
Study Start
April 2016
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
This study is a randomized clinical trial, which will follow and evaluate 120 kidney transplant recipients over one year. There will be two groups: a control group and the intervention group. The dietitian visits will happen monthly during the first six months and twice in the last six months.The intervention group will receive a high-protein and low glycemic index diet (1,3g/kg/day of protein) and the control group will keep following the hospital standard protocol. The study assessments (weight, anthropometry and biochemistry) will be performed during these visits over one year after the randomization period.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 2016
Date type not reportedThis date has not been verified as actual or estimated.
August 3, 2016
Actual (reported)August 30, 2016
Actual (reported)December 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Weight Change
Digital Balance
Baseline, 1st month, 2nd month, 3rd month, 4th month, 5th month, 6th month, 9th month and 12th month.
Body Composition Change
Baseline, 3rd month, 6th month, 9th month and 12th month.
Basal Metabolic Rate
Baseline and 6th month.
Satiety
Baseline, 3rd month, 6th month, 9th month and 12th month for intervention group and at baseline for control group.
Kidney function
12 months
Glycated hemoglobin
Baseline, 3rd month, 6th month, 9th month and 12th month.
A protocol of a high protein and low glycemic index diet.
A protocol of a conventional diet.
It will be evaluated a type of high protein diet with 1,3g/kg/day in kidney transplant recipients over 1 year after transplantation.
Conventional diet over 1 year after transplantation.
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-903, Brazil
Pedrollo EF, Correa C, Nicoletto BB, de Melo Cardoso de Freitas J, Buboltz JR, da Costa BDF, Dos Santos Guedes G, Bauer AC, Manfro RC, Souza GC, Leitao CB. Effect of an intensive nutrition intervention of a high protein and low glycemic load diet on weight of kidney transplant recipients: a randomized clinical trial. Endocrine. 2025 Jan;87(1):106-115. doi: 10.1007/s12020-024-03978-y. Epub 2024 Aug 5.
Pedrollo EF, Nicoletto BB, Carpes LS, de Freitas JMC, Buboltz JR, Forte CC, Bauer AC, Manfro RC, Souza GC, Leitao CB. Effect of an intensive nutrition intervention of a high protein and low glycemic-index diet on weight of kidney transplant recipients: study protocol for a randomized clinical trial. Trials. 2017 Sep 6;18(1):413. doi: 10.1186/s13063-017-2158-2.
Elis Forcellini Pedrollo, Master
Hospital de Clinicas de Porto Alegre
First Submitted
August 3, 2016
First Posted
August 30, 2016
Study Start
April 2016
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2018
Estimated (date passed)Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
August 30, 2016
Record last verified: 2016-08
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Source: ClinicalTrials.gov.
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