A randomised study to evaluate a high protein weight loss diet Vs a low glycaemic index diet on renal function in subjects with early diabetic nepropathy who are overweight.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12608000045314

Enrollment

Registered

2008-01-29

Start date

2007-09-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Subjects with early diabetic nepropathy who are overweight and randomized to receive a high protein weight loss diet. The protein content will be 30-35% of total energy. Diet will last for 12 months. Protein will be mainly by red meat consumed four times a week.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

Type 2 diabetics with microalbuminuria (30–600 mg/24 h or an albumin-to-creatinine ratio of 3.0–30 mg/mmol) with or without mildly impaired renal function (estimated GFR 40-75 ml/min/1.73m2, as calculated from serum creatinine). Able to give informed consent.

Exclusion criteria

Body mass index (BMI) less than 27, unstable cardiovascular, hepatic, pulmonary disease or medical condition that would make participation in trial unsafe. Not pregnant or breastfeeding.

Outcome results