Status:
UNKNOWN
Dietary Intervention Trial Targeting Metabolic Syndrome After Kidney Transplantation
Lead Sponsor:
University Medical Center Groningen
Conditions:
Kidney Transplant; Complications
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Kidney transplant recipients (KTR) have a considerably lower life expectancy as compared with the general population, primarily due to a high prevalence of cardiovascular diseases. KTR often develop a...
Eligibility Criteria
Inclusion
- Age 18 years or older.
- Given informed consent.
- At least 6 months after kidney transplantation.
- Stable renal function with an estimated glomerular filtration rate (eGFR) \> 30 mL/min.
- Raised systolic blood pressure (≥130 mmHg) and at least two more features of metabolic syndrome: central obesity (waist circumference ≥102 for men and ≥88cm for women), elevated triglycerides (≥ 1.7 mmol/L), reduced HDL-C (\< 1.0 mmol/L for men and \< 1.3 mmol/L for women) or on drug treatment for reduced HDL, elevated plasma glucose (≥ 5.6 mmol/L) or on drug treatment for elevated glucose9.
- Approval by nephrologist for participation in the study.
Exclusion
- Active medical illness, including rejection of the graft.
- Psychopathology or serious cognitive impairment.
- Necessity to follow specific dietary measures for health purposes that conflict with the study diets.
- Use of insulin or sulfonylurea (SU)-derivates.
- Language barrier.
- Pregnancy or lactating.
- Serum potassium \> 5.0 mmol/L that requires dietary measures.
- Moderate or severe malnutrition (Patient-Generated Subjective Global Assessment (PG-SGA) stage B or C). In this case, patient will be referred to a renal dietician.
- Participation in other intervention trials.
Key Trial Info
Start Date :
January 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2022
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04698408
Start Date
January 1 2021
End Date
October 1 2022
Last Update
January 6 2021
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