Higher protein, lower carbohydrate diet to reduce glycated haemoglobin (HbA1c)

Not Applicable

Recruiting

• Conditions: Diabetes mellitus (type 2); Metabolic and Endocrine - Diabetes; Diet and Nutrition - Obesity

• Registration Number: ACTRN12612000676819
• Lead Sponsor: Baker IDI Heart & Diabetes Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-06-25
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

i) Type 2 diabetes
ii) HbA1c greater than 7.5% within the last 6 months - maybe unmedicated for diabetes or on insulin or oral hypoglycaemic medication

Exclusion Criteria

Bariatric surgery, pregnant / lactating, not following a low carbohydrate diet within the last 3 months

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
HbA1c using fasting venous blood samples[Baseline (0 months), 3 months and 6 months.]

Secondary Outcome Measures

Name	Time	Method
A single spot urine sample will also be collected on these three occasions and analysed for sodium and potassium/creatinine ratio.[Baseline (0 months), 3 months and 6 months.];Dietary intake. All volunteers (intervention and control) will be required to complete a food diary listing all foods and drinks consumed, along with approximate amounts.[3 consecutive days of every month from baseline to 6 months (6 times in total).];Body weight - measured using scientific-quality scales[Baseline (0 months), 3 months and 6 months];Blood pressure - measured using standard medical sphygmomanometer in clinic[Baseline (0 months), 3 months and 6 months.];Fasting blood glucose using fasting venous blood samples[Baseline (0 months), 3 months and 6 months.];Fasting lipids using fasting venous blood samples[Baseline (0 months), 3 months and 6 months.]