Study characteristics |
Methods |
Study design: cross‐over RCT
Recruitment: May to August 1972 (trial 1) and February to May 1973 (trial 2)
Study duration: 13 to 15 weeks (5 to 6 weeks for each intervention phase and a 2 to 3 week washout period)
|
Participants |
Country: UK
Setting: single centre, hospital outpatient clinic
Inclusion criteria: kidney transplant with satisfactory function (this criteria not reported), obesity or cushingoid appearance
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Number
Mean age ± SD (years): not reported
Sex (M/F): trial 1 (6/5); trial 2 (8/6)
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Baseline characteristics
Nationality: not reported
Ethnicity: not reported
Mean baseline BMI (kg/m²): not reported
Stage of CKD: transplant recipients
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: 32% of participants had hypercholesterolaemia.
Exclusion criteria: oedema; fasting blood glucose level < 90 mg/100 mL
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Interventions |
Trial 1
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Intervention first group
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Control first group
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Co‐interventions
Trial 2
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Intervention first group
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Control first group
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Co‐interventions
|
Outcomes |
Weight loss (kg)
Body weight (kg)
Total cholesterol (mg/100 mL)
Adverse patient outcomes associated with each weight loss intervention
BP (mmHg)
Triglycerides (mg/100 mL)
|
Notes |
Founding source: not reported
Trial registration: not applicable as published before 2006
Possible conflicts of interest for study author: not reported
Fenfluramine the appetite suppressant used in this trial, was withdrawn from the market in 1997 due to safety reasons and is no longer approved as a drug
|
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Unclear risk |
Insufficient information to permit judgement ‐ not reported how participants were randomised |
Allocation concealment (selection bias) |
Low risk |
Allocation not revealed until un‐blinding |
Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
Placebo randomised controlled double blind trial |
Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
Blinded outcome assessors |
Incomplete outcome data (attrition bias)
All outcomes |
High risk |
Missing data not well reported, 22% attrition rate |
Selective reporting (reporting bias) |
Unclear risk |
Insufficient information to permit judgement ‐ some outcome measures not well reported |
Other bias |
Low risk |
Nil other potential sources of bias identified |