Skip to main content
. 2021 Mar 30;2021(3):CD013119. doi: 10.1002/14651858.CD013119.pub2

Teplan 2002.

Study characteristics
Methods
  • Study design: parallel RCT

  • Recruitment: enrolment start and finish date not reported

  • Study duration: up to 36 months

Participants
  • Country: Czech Republic

  • Setting: not reported

  • Inclusion criteria: included individuals who were obese BMI ≥ 30 kg/m² and at least 1 year post kidney transplant

  • Number: intervention group (128); control group (130)

  • Age range: 22 to 78 years

  • Sex (M/F): 108/150

  • Baseline characteristics

    • Nationality: not reported

    • Ethnicity: not reported

    • Mean baseline BMI (kg/m²): not reported

    • Stage of CKD: kidney transplant recipients > 1 year post transplant

    • Mean baseline eGFR ± SD (mL/min/1.73 m²): not reported

    • Mean baseline SBP ± SD (mmHg): not reported

    • Mean baseline DBP ± SD (mmHg): not reported

    • Mean baseline energy intake ± SD (kcal/day): not reported

    • Comorbid conditions: not reported

  • Exclusion criteria: not reported

Interventions
  • Intervention type classification: mixed (lifestyle + pharmacological)

  • Weight loss intervention/s used: dietary + pharmacological


Intervention group (diet group)
  • Individualised low energy and low fat diet + corticoids withdrawal. After 3 months participants were given orlistat at a dose of up to 3 x 120 mg/day and statins for 3 years. Nil further information on who delivered the intervention and what participants received was reported


Control group
  • Usual care for up to 3 years. Nil further information on what was usual care


Co‐interventions
  • Not reported

Outcomes
  • BMI (kg/m²)

  • CrCl (mL/s)

  • Proteinuria (units not reported)

  • Fasting blood glucose (mmol/L)

  • Total cholesterol (mmol/L)

  • LDL cholesterol (mmol/L)

  • HDL cholesterol (mmol/L)

  • Triglycerides (mmol/L)

Notes
  • Founding source: IGA ND/5686‐3

  • Trial registration: not reported

  • Possible conflicts of interest for study author: not declared (no statement provided)

  • Abstract‐only publication

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Insufficient information to permit judgement
Allocation concealment (selection bias) Unclear risk Insufficient information to permit judgement
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Insufficient information to permit judgement
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Insufficient information to permit judgement
Incomplete outcome data (attrition bias)
All outcomes Unclear risk Insufficient information to permit judgement
Selective reporting (reporting bias) Unclear risk Insufficient information to permit judgement
Other bias Unclear risk Insufficient information to permit judgement