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. 2023 Aug 31;2023(8):CD013074. doi: 10.1002/14651858.CD013074.pub2

Mohamed 2013.

Study characteristics
Methods Study design
  • Parallel RCT


Study dates
  • Duration of follow‐up: 12 weeks

  • Time frame: not reported

Participants Study characteristics
  • Setting: multicentre (2 tertiary care hospitals affiliated with an academic centre)

  • Country: not reported

  • Inclusion criteria: patients ≥ 18 years with type 2 diabetes undergoing HD

  • Exclusion criteria: not reported


Baseline characteristics
  • Number (analysed/randomised): intervention group 1 (not reported/15); intervention group 2 (not reported/19)

  • Median age, IQR (years): intervention group 1 (73, 45 to 88); intervention group 2 (65, 35 to 95)

  • Sex (M/F): intervention group 1 (9/6); intervention group 2 (11/8)

  • Dialysis type: HD

  • Median dialysis vintage, IQR (years): intervention group 1 (2.83, 1.0 to 6.58); intervention group 2 (1.42, 0.42 to 8.0)

  • Comorbidities

    • CVD: not reported

    • Diabetes: intervention group 1 (15/15); intervention group 2 (19/19)

    • Hypertension: not reported

    • Depression: not reported

Interventions Intervention classification
  • Pharmacological intervention

  • Indication: study reporting fatigue


Intervention group 1
  • Higher dialysate glucose concentration baths: 11 mmol/L


Intervention group 2
  • Standard dialysate glucose concentration baths: 5.5 mmol/L


Co‐interventions
  • Not reported

Outcomes Outcomes reported
  • Fatigue outcome measures used: validation data available

  • HbA1c: assessed at baseline and at week 12

  • HRQoL

    • RAND SF‐36 (including fatigue assessment): assessed at baseline and at week 12

      • General component

      • Social function

Notes Additional information
  • Funding: not reported

  • Conflicts of interest/disclosures: not reported

  • Trial registration identification number: not reported

  • A priori published protocol: not reported

  • Abstract

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Sequence generation methods were not reported in sufficient detail to permit judgement
Allocation concealment (selection bias) Unclear risk Method of allocation concealment was not reported in sufficient detail to permit judgement
Blinding of participants and personnel (performance bias)
All outcomes High risk Quote: "Participants were randomised in an open‐label fashion."
Comment: An open‐label study was considered as high risk of bias
Blinding of outcome assessment (detection bias)
All outcomes High risk The outcomes were assessed with an appropriate measure, without differences between groups. However, subjective measures were used, it was not stated whether outcomes were assessed without knowledge of treatment allocation, and knowledge of treatment assignment may have influenced reporting. Participant beliefs about the superiority/inferiority of either intervention could have influenced their assessment of the outcome, but there was no evidence that this was likely. However, objective and subjective outcomes were assessed
Incomplete outcome data (attrition bias)
All outcomes High risk Quote: "One patient withdrew in the third week from the higher DGC group."
Comment: The number of patients who completed the study was not clearly stated. It was unclear if there was evidence that the results were not biased by missing outcome data
Selective reporting (reporting bias) High risk Information about the protocol and the statistical analysis plan were not reported. Outcomes information were not reported in sufficient detail to permit judgment. All outcomes that should be addressed (fatigue, cardiovascular disease, and death) were not reported
Other bias Unclear risk No data were available to assess the possible imbalance between groups. Funding and conflicts of interest were not reported