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. 2021 Mar 30;2021(3):CD013119. doi: 10.1002/14651858.CD013119.pub2

Praga 1995.

Study characteristics
Methods
  • Study design: parallel RCT

  • Recruitment: enrolment start and finish date not reported

  • Study duration: 12 months

Participants
  • Country: Spain

  • Setting: single‐centre; obesity outpatient clinic

  • Inclusion criteria: obesity BMI > 30kg/m², proteinuria >1 g/24 hour (on at least 3 consecutive determinations)

  • Number: intervention group (9); control group (8)

  • Mean age ± SD (years): intervention group (47.3 ± 8.0); control group (49.5 ± 12.7)

  • Sex (M/F): intervention group (4/5); control group (2/6)

  • Baseline characteristics

    • Nationality: not reported

    • Ethnicity: not reported

    • Mean baseline BMI (kg/m²): intervention group (1 37.1 ± 3.1); control group (38.2 ± 5.0)

    • Stage of CKD: not reported

    • 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: sleep apnoea (29%)

  • Exclusion criteria: diabetes mellitus; systemic disease

Interventions
  • Intervention type classification: lifestyle

  • Weight loss intervention/s used: dietary


Intervention group (hypocaloric diet)
  • Were instructed to follow a 1000 to 400 kcal/day diet without a protein restriction. Nil further information on intervention delivery information, who delivered the intervention


Control group (captopril without dietary change)
  • Maintained their usual dietary habits without any dietary changes. They started captopril treatment prescribed at 25 mg/day to 50 mg/day in 2 divided doses, to begin with. Later the dose was adjusted according with BP (mean dose 78 mg ± 36 mg/day). Nil further information on intervention delivery information, who delivered the intervention


Co‐interventions
  • Not reported

Outcomes
  • BMI (kg/m²)

  • CrCl (mL/min)

  • SCr (mg/dL)

  • Proteinuria (g/24 hour)

  • Albuminuria (g/dL)

  • Total cholesterol (mg/dL)

  • Triglycerides (mg/dL)

Notes
  • Founding source: not reported

  • Trial registration: not applicable as published before 2006

  • Possible conflicts of interest for study author: not declared

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Insufficient information to permit judgement ‐ no description of randomisation sequence
Allocation concealment (selection bias) Unclear risk Insufficient information to permit judgement ‐ no description of allocation concealment
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 ‐ no details on if assessors were blinded or not
Incomplete outcome data (attrition bias)
All outcomes Unclear risk Insufficient information to permit judgement
Selective reporting (reporting bias) High risk Many reported outcome measures have not been reported adequately
Other bias Unclear risk Insufficient information to permit judgement