Prevention of Weight Gain and Impaired Glucose Metabolism Post Kidney Transplantation: A Pilot and Feasibility Study

University of Kansas Medical Center1 site in 1 country60 target enrollmentDecember 17, 2024

ConditionsKidney Transplant Overweight or Obese Adults Glucose Control

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Kidney Transplant
Sponsor: University of Kansas Medical Center
Enrollment: 60
Locations: 1
Primary Endpoint: Body Weight
Status: Recruiting
Last Updated: 11 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The goal of this clinical trial is to learn whether if it is feasible to implement a study of patients receiving kidney transplantation, to learn if these patients will complete selective outcomes measurements, and to examine if a lifestyle intervention may assist with preventing weight gain compared to standard medical care. The main questions it aims to answer are:

Is it feasible to recruit and retain patients who have undergone kidney transplantation into a study to compare standard medical care to standard medical care plus a lifestyle intervention focused on prevention of weight gain?
Will participants engage in the interventions and be compliant to the components of the interventions?
Will there be any difference between the interventions between the interventions for the occurrence of adverse events specific to kidney transplantation?
Will there be initial effectiveness for the standard medical care plus a lifestyle intervention to have a better effect on preventing weight gain compared to standard medical care alone?
Will there be initial effectiveness for the standard medical care plus a lifestyle intervention to have a better effect on body composition compared to standard medical care alone?
Will there be initial effectiveness for the standard medical care plus a lifestyle intervention to have a better effect on fasting glucose compared to standard medical care alone?
Will there be initial effectiveness for the standard medical care plus a lifestyle intervention to have a better effect on fasting insulin compared to standard medical care alone?
Will there be initial effectiveness for the standard medical care plus a lifestyle intervention to have a better effect on insulin sensitivity compared to standard medical care alone?
Will there be initial effectiveness for the standard medical care plus a lifestyle intervention to have a better effect on physical function compared to standard medical care alone?
Will there be initial effectiveness for the standard medical care plus a lifestyle intervention to have a better effect on health-related quality of life compared to standard medical care alone?
Will there be initial effectiveness for the standard medical care plus a lifestyle intervention to have a better effect on changes in dietary intake compared to standard medical care alone?
Will there be initial effectiveness for the standard medical care plus a lifestyle intervention to have a better effect on physical activity and sedentary behavior compared to standard medical care alone?

Participants will:

Participants will continue with their standard medical care following kidney transplantation.
Participants only receiving standard medical care will also complete brief monitoring visits at week 6, 12, and 18.
Participants receiving the lifestyle intervention will attend weekly intervention sessions and will be recommended to modify their diet and physical activity behaviors in an effort to prevent weight gain.
Participants will complete outcome measurements as the start of the study and again after 6 months in the study.
After 6 months in the study, participants will also complete a brief intervention and answer other questions about their experience in the study.

Registry

clinicaltrials.gov

Start Date

December 17, 2024

End Date

March 1, 2027

Last Updated

11 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University of Kansas Medical Center

Responsible Party

Principal Investigator

John M. Jakicic, PhD

Professor

University of Kansas Medical Center

Eligibility Criteria

Inclusion Criteria

•Receiving a kidney transplant within the prior 3-5 months, with the transplant received from a deceased donor or living donor. NOTE: The patient will be eligible for randomization at 3 months following the kidney transplant, or at a subsequent time once clearance from the kidney transplant physician is given, provided that the time does not exceed 5 months following the kidney transplant.
•Both males and females of all race/ethnic groups are eligible for participation in this study.
•\>=18 years of age.
•Body mass index (BMI) \>22 kg/m
•There is no maximal BMI provided that the weight does not exceed the weight allowance of the dual-energy x-ray absorptiometer (DXA) that is used to assess body composition (maximal weight for the DXA is 350 pounds).
•Ability to provide informed consent prior to participation in this study.
•Ability to provide clearance from their kidney transplant physician to engage in the diet and physical activity components of the proposed intervention and to safely complete the proposed outcome measures.
•Ability to walk for exercise.

Exclusion Criteria

•Females who are pregnant, breastfeeding, or reporting a planned pregnancy during the study period. Female participants of childbearing age who are not currently taking contraceptive medication, are not post-menopausal, or have not been surgically sterilized will need to agree to use a double barrier method of contraception.
•History of bariatric surgery.
•Currently prescribed an anti-obesity medication.
•Report current medical condition or treatment for a medical condition that could affect body weight. These may include the following: diabetes mellitus; hyperthyroidism; inadequately controlled hypothyroidism; chronic liver disease; cancer; gastrointestinal disorders including ulcerative colitis, Crohn's disease, or malabsorption syndromes; etc.
•Current congestive heart failure, angina, uncontrolled arrhythmia, symptoms indicative of an increased acute risk for a cardiovascular event, prior myocardial infarction, coronary artery bypass grafting or angioplasty, conditions requiring chronic anticoagulation (i.e., recent or recurrent DVT).
•Resting systolic blood pressure of \>=160 mmHg or resting diastolic blood pressure of \>=100 mmHg or not on a stable medical treatment to control hypertension (stable dose is defined as the same dose and type of medication for a period of at least 6 months).
•Eating disorders that would contraindicate modifying eating or physical activity behaviors.
•Alcohol or substance abuse.
•Currently treated for psychological issues (i.e., depression, bipolar disorder, etc.) that is accompanied by the following: 1) not on a stable dose of medications for treatment within the previous 12 months, or 2) hospitalized for depression within the previous 5 years.
•Report plans to relocate to a location not accessible to the study site or having employment, personal, or travel commitments that prohibit attendance at scheduled intervention sessions or assessments.

Outcomes

Primary Outcomes

Body Weight

Time Frame: 0 and 6 months

Body weight will be assessed in duplicate using a calibrated digital scale to the nearest 0.1 kg.

Secondary Outcomes

Body Mass Index(0 and 6 months)
Percent body fat(0 and 6 months)
Body Fat Mass(0 and 6 months)
Lean Body Mass(0 and 6 months)
Bone mineral content(0 and 6 months)
Waist Circumference(0 and 6 months)
Hip Circumference(0 and 6 months)
Resting blood pressure(0 and 6 months)
Resting heart rate(0 and 6 months)
Physical Function(0 and 6 months)
Fasting glucose(0 and 6 months)
Fasting Insulin(0 and 6 months)
Insulin Resistance(0 and 6 months)
Kidney function(0 and 6 months)
Physical activity(0 and 6 months)
Physical Activity(0 and 6 months)
Sedentary behavior(0 and 6 months)
Energy Intake (Dietary Intake)(0 and 6 months)
Weight Loss Strategies(0 and 6 months)
Health-Related Quality of Life(0 and 6 months)
Adverse and Serious Adverse Events(0 and 6 months and at other times when reported by the participant)