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Principal Investigator: DIANE M CIBRIK
Organization: UNIVERSITY OF KANSAS MEDICAL CENTER
Fiscal Year: 2024
Award: $310,000
Funding agency: National Institute of Diabetes and Digestive and Kidney Diseases
Project Summary
For patients with end-stage renal disease, kidney transplantation is the best clinical treatment.
While this procedure improves kidney function and survival in these patients, kidney
transplantation is also associated with an increase in cardiometabolic disease, which includes
glucose intolerance/insulin resistance that leads to development of diabetes mellitus, which may
impact on the transplanted kidney. Weight and adipose gain following kidney transplantation has
been implicated for these deleterious cardiometabolic effects, and potential impact on kidney
function and kidney graft failure. The increase in weight/adiposity may be related to a combination
of medications related to transplantation and/or positive energy balance resulting from an
increase in energy intake without a sufficient compensatory increase in energy expenditure (e.g.,
increased physical activity). Interventions to address weight gain have focused on the prevention
of positive energy balance (energy intake does not exceed energy expenditure). There is a
scarcity of rigorous data available in the literature addressing dietary interventions and the effect
on body weight following kidney transplantation. The existing literature of diet or diet plus physical
activity has moderate to high risks of bias that limit the use for drawing conclusions on prevention
of weight gain and related onset of impaired glucose metabolism. We propose a study of high
scientific rigor to address this limitations in an effort to enhance the health of kidney transplant
recipients.
We propose this study to build on our intervention and clinical experience to conduct a 6-
month pilot and feasibility study in patients who have received a kidney transplant. We will initially
undertake efforts to refine our intervention components to confirm their applicability to this patient
population. We will the recruit and randomize participants to Standard Care or a Lifestyle
Intervention focus on weight gain prevention. The aims of this study are: 1) We will adapt our
intervention approach to this patient population, 2) We will examine the feasibility of randomizing
and retaining participants within our approach, 3) We will examine fidelity and compliance to the
components of the intervention, 4) We will conduct safety monitoring to assess for adverse
outcomes that are specific to kidney transplantation. Based on this pilot and feasibility clinical trial,
and our “Go/No Go” criteria, we will finalize the study protocol, manual of procedures, and effect
size estimates for a subsequent full-scale R01 application.
Terms: <Address><Adipose tissue><Adult-Onset Diabetes Mellitus><Area><Biological Markers><Body Weight><Body Weight decreased><Caloric Intake><Cardiometabolic Disease><Cardiometabolic Disorder><Caring><Clinical><Clinical Treatment><Clinical Trials><Combination Medication><Conduct Clinical Trials><Cost Effectiveness Analysis><Data><Development><Diabetes Mellitus><Diet><Dietary Intervention><Disease><Disorder><ESRD><Effectiveness><End stage renal failure><End-Stage Kidney Disease><End-Stage Renal Disease><Energy Expenditure><Energy Intake><Energy Metabolism><Fatty Tissue><Feasibility Studies><Feedback><Focus Groups><Foundations><Funding Mechanisms><Funding Opportunities><Glucose Intolerance><Health><Human><Impairment><Insulin Resistance><Intervention><Intervention Strategies><Kansas><Ketosis-Resistant Diabetes Mellitus><Kidney><Kidney Grafting><Kidney Transplantation><Kidney Transplants><Kidney Urinary System><Literature><Manuals><Maturity-Onset Diabetes Mellitus><Medical Directors><Medical center><Methods><Mission><Modern Man><Monitor><NIDDK><NIDDM><National Institute of Diabetes and Digestive and Kidney Diseases><Non-Insulin Dependent Diabetes><Non-Insulin-Dependent Diabetes Mellitus><Noninsulin Dependent Diabetes><Noninsulin Dependent Diabetes Mellitus><Nutrition Interventions><Nutritional Interventions><Obesity><Organ Procurements><Outcome><Outcome Measure><Participant><Pathway interactions><Patients><Physical activity><Physician Executives><Pilot Projects><Prevention><Procedures><Process><Protocol><Protocols documentation><Provider><Randomized><Recommendation><Renal Grafting><Renal Transplantation><Renal Transplants><Renal function><Reporting><Safety><Sample Size><Slow-Onset Diabetes Mellitus><Stable Diabetes Mellitus><T2 DM><T2D><T2DM><Testing><Transplant Recipients><Transplantation><Type 2 Diabetes Mellitus><Type 2 diabetes><Type II Diabetes Mellitus><Type II diabetes><United States><Universities><Weight><Weight Gain><Weight Increase><Weight Loss><Weight Reduction><Work><adipose><adiposity><adult onset diabetes><adverse consequence><adverse outcome><bio-markers><biologic marker><biomarker><body weight gain><body weight increase><body weight loss><caloric dietary content><cardiometabolic><cardiometabolism><corpulence><cost efficient analysis><cost-effective analysis><developmental><diabetes><diet intervention><dietary><diets><energy balance><experience><glucose metabolism><graft failure><high risk><improved><insulin resistant><insulin tolerance><intervention effect><interventional strategy><ketosis resistant diabetes><kidney function><kidney tx><life style intervention><lifestyle intervention><maturity onset diabetes><measurable outcome><novel><nutrition><organ procurement transplantation network><outcome measurement><participant retention><pathway><patient population><pilot study><prevent><preventing><programs><randomisation><randomization><randomly assigned><recruit><renal><standard care><standard treatment><systematic review><transplant><transplant patient><trial regimen><trial treatment><type 2 DM><type II DM><type two diabetes><weight gain prevention><weights><white adipose tissue><wt gain><wt-loss><yellow adipose tissue>