The effect of high protein, low carbohydrate diets in the treatment of type 2 diabetes

The effect of high protein, low carbohydrate diets on glycaemic control and weight in the treatment of type 2 diabetes

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12605000063617

Enrollment

108

Registered

2005-08-01

Start date

2005-05-05

Completion date

2005-12-15

Last updated

2021-06-14

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

Conditions

None listed

Brief summary

This study will determine if high protein, low carbohydrate diets are superior to standard high carbohydrate diets in people with type diabetes.

Interventions

Participants are randomised to one of two diets - (1) high carbohydrate, low protein (55% CHO, 15% pr, 30% fat) or (2) low carbohydrate, high protein (40% CHO, 30% pr, 30% fat), over 12 months.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

30 Years to 75 Years

Healthy volunteers

Inclusion criteria

Patients participating in the study will have type 2 diabetes, with body mass index (BMI) between 27 and 40 kg/m2, and HbA1c between 6.5 and 10%. Women of childbearing potential will need to agree to take adequate contraception throughout the study period.Prior to study entry, weight should be stable, with no more than 3 kg change in the previous 3 months.

Exclusion criteria

Patients will be excluded if they have significant heart disease (unstable angina, cardiac failure, or recent [within the previous 3 months] MI, CABG or other coronary intervention), stroke within the previous 3 months, renal disease (proteinuria or serum creatinine > 0.13 mmol/l), liver disease or malignancy.

Outcome results