Dietary Intervention Trial targeting metabolic syndrome after renal Transplantation

Dietary Intervention Trial targeting metabolic syndrome after renal Transplantation - DIETTX

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON57829

Enrollment

Registered

2020-12-17

Start date

2021-01-01

Completion date

Unknown

Last updated

2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

insulin resistance metabolic syndrome

Interventions

Diet 1 is concordant with the DNG. Diet 2, the transplant-targeted diet, consists of a moderate carbohydrate reduction (30 en%), which is replaced by protein and unsaturated fatty acids. All partici

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Renal transplant recipients that are - 18 years or older - more than 6 months after renal transplantation with stable renal function (estimate glomerular filtration rate (eGFR) > 30 mL/min/1.73m2) - a systolic blood pressure * 130 mmHg - and at least two other features of metabolic syndrome according to the ATP III criteria

Exclusion criteria

Exclusion criteria: - 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.

Design outcomes

Primary

Measure	Time frame
The primary study outcomes are systolic blood pressure (SBP)	—

Secondary

Measure	Time frame
Secondary outcome measures includes other cardio-metabolic risk factors (lipids: triglycerides, low-density-lipoprotein cholesterol (LDL-C) and high-density-lipoprotein cholesterol (HDL-C); glucose metabolism (fasting glucose levels, insulin resistance, measured by the homeostatic model assessment of insulin resistance (HOMA-IR)), body composition (changes in weight, body mass index (BMI), waist circumference, fat and muscle tissue mass percentage by bio-electrical impendance assessment (BIA)), physical functioning (handgrip strength (HGS) and Five Times Sit To Stand Test), dietary intake (assessed by food diaries and 24-hour urine samples) and quality of life (QoL) .	—

Measure

Time frame

Secondary outcome measures includes other cardio-metabolic risk factors (lipids: triglycerides, low-density-lipoprotein cholesterol (LDL-C) and high-density-lipoprotein cholesterol (HDL-C); glucose metabolism (fasting glucose levels, insulin resistance, measured by the homeostatic model assessment of insulin resistance (HOMA-IR)), body composition (changes in weight, body mass index (BMI), waist circumference, fat and muscle tissue mass percentage by bio-electrical impendance assessment (BIA)), physical functioning (handgrip strength (HGS) and Five Times Sit To Stand Test), dietary intake (assessed by food diaries and 24-hour urine samples) and quality of life (QoL) .

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)