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

Jesudason 2013.

Study characteristics
Methods

  • Study design: parallel RCT (75 eligible, 65 randomised, 45 analysed)

  • Study dates: enrolment start and finish date not reported

  • Study duration: 12 month intervention
Participants

  • Country: Australia

  • Setting: single centre; research organisation

  • Inclusion criteria: type 2 diabetes mellitus (drug treated or fasting blood glucose > 7mmol/L or 2 hour blood glucose > 11.1 mmol/L) with microalbuminuria (30 to 300 mg/24 hour or ACR of 3.0 mg/mmol to 30 mg/mmol); eGFR > 40 mL/min/1.73 m² and BMI > 27 kg/m²

  • Number: moderate protein group (21); standard protein group (24)

  • Mean age ± SD (years): moderate protein group (59.4 ± 2.2); standard protein group (62.4 ± 1.7)

  • Sex (M/F): moderate protein group (15/6); standard protein group (20/4)

  • Baseline characteristics

    • Nationality: not reported

    • Ethnicity: not reported

    • Mean baseline BMI (kg/m²): moderate protein group (36.7); standard protein group (35.4)

    • Stage of CKD: 1 and 2 and part of stage 3 (eGFR > 40 mL/min/1.73 m²)

    • Mean baseline eGFR ± SD (mL/min/1.73 m²): moderate protein group (98 ± 6); standard protein group (91 ± 6)

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

    • Mean baseline DBP ± SD (mmHg): moderate protein group (75 ± 7); standard protein group (71 ± 9)

    • Mean baseline energy intake (kJ/day): moderate protein group (9300 ± 5300); standard protein group (8400 ± 3768)

    • Comorbid conditions: type 2 diabetes (100%)

  • Exclusion criteria: coronary artery disease or any other active disease of clinical significance
Interventions

  • Intervention type classification: lifestyle

  • Weight loss intervention/s used: dietary


Moderate protein group

  • 6000 kJ/day for women, 7000 kJ/day for men. Target 30% protein, 30% fat, 40% carbohydrate. Protein target 90 to 120 g/day. Alcohol was limited to 2 standard drinks/week. Participants attended a diet visit every 2 weeks for 16 weeks and monthly visits for measurement of weight, BP, and diet. A booklet with dietary information, recipes and a sample meal plan was provided. It was not reported who delivered the dietary intervention


Standard protein group

  • 6000 kJ/day for women, 7000 kJ/day for men. Target 20% protein, 30% fat, 50% carbohydrate. Protein target 55 to 70 g/day. Alcohol was limited to 2 standard drinks/week. Participants attend a diet visit every 2 weeks for 16 weeks and monthly visits for measurement of weight, BP, and diet. A booklet with dietary information, recipes and a sample meal plan was provided. It was not reported who delivered the dietary intervention


Co‐interventions

  • Not reported
Outcomes

  • Body weight (kg)

  • Body composition (lean mass & fat mass ‐ DEXA)

  • Albuminuria (24‐h urinary albumin excretion) (mg/min)

  • Glomerular hyperfiltration (defined as GFT > 120 mL/min)

  • Measured GFR (mL/min/1.73 m²)

  • SBP (mmHg)

  • DBP (mmHg)

  • Anti‐hypertensive medication changes

  • HbA1c (%)

  • Hypoglycaemic medication changes

  • Adherence to treatment

  • Dietary intake (energy intake kJ/day)
Notes

  • Founding source: not reported

  • Additional data: requested ‐ Appendix 3

  • Trial registration: The Australian New Zealand Clinical Trials Registry (ANZCTR) No. 12608000045314

  • Possible conflicts of interest for study author: none declared
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "Random assignment was carried out before inclusion on the basis of computer‐generated random‐number list"
Allocation concealment (selection bias) Low risk Quote: "The allocation sequence was concealed in sealed envelopes from the researcher who enrolled and assessed participants"
Blinding of participants and personnel (performance bias)
All outcomes High risk Blinding of participants or study personnel was not described. Participants were randomised to one of two dietary intervention therefore study participants were unlikely to be blinded
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Insufficient information to permit judgement
Incomplete outcome data (attrition bias)
All outcomes High risk High levels of attrition in both groups: moderate protein group (38%); standard protein group (23%)
Selective reporting (reporting bias) High risk Selective reporting of some outcome measures after baseline
Other bias Unclear risk Insufficient information to permit judgement. Some imbalances at baseline in albuminuria. Also wide ranging baseline kidney function