Investigating a low carbohydrate/high protein diet in type 2 diabetes patients

Completed

• Conditions: Type 2 diabetes mellitus; Nutritional, Metabolic, Endocrine

• Registration Number: ISRCTN05903336
• Lead Sponsor: niversity of Chester (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01-21
• Last Update Posted: 6 February 2017

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

Current inclusion criteria as of 18/09/2014:
1. Male or female, aged 18-75
2. BMI 28-40 kg/m*2
3. HbA1c <86 mmol and a diagnosis of diabetes confirming to WHO guidelines
4. Stable medication at least three months prior to the study
5. Diabetes managed with Metformin or lifestyle only
6. English speaking with internet access

Previous inclusion criteria:
1. Male or female, aged 18-75
2. BMI 28-40 kg/m*2
3. HbA1c <64 mmol and a diagnosis of diabetes conforming to WHO guidelines
4. Stable medication at least three months prior to the study
5. Diabetes managed with Metformin or lifestyle only
6. English speaking with internet access

Exclusion Criteria

Current exclusion criteria as of 18/09/2014:
1. History of eating disorder
2. Currently following a restrictive diet
3. Currently taking part in other research
4. Impaired kidney function
5. Impaired liver function
6. Patients taking medications to reduce blood clots
7. Pregnant women
8. Non-English speaking
9. No internet access

Previous exclusion criteria:
1. History of eating disorder
2. Currently following a restrictive diet
3. Currently taking part in other research
4. Impaired kidney function
5. Impaired liver function
6. Patients taking medications to reduce blood clots or promote production of urine
7. Pregnant women
8. Non-English speaking
9. No internet access

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Blood samples will be taken by phlebotomists/practice nurses working at the City Walls Medical Practice. They will be analysed at the Countess of Chester laboratory which is accredited by CPA (UK) Ltd. The following will be measured:<br>1. Fasting plasma glucose/fasting plasma insulin<br>2. Glycosylated haemoglobin<br>3. Lipid profile (total serum cholesterol, HDL serum cholesterol, fasting serum triglycerides - from these LDL cholesterol and cholesterol/HDL ratio will also be calculated) <br>4. Kidney function (serum creatinine and urea, eGFR will then be calculated)<br>5. Liver function tests (gamma glutamyl transpeptidase, alanine transaminase, aspartate aminotransferase, alkaline phosphatase, albumin, total protein, bilirubin)<br>6. Serum potassium, serum sodium, C-reactive protein<br>7. Serum ketones<br>8. Measures of oxidative stress (e-selectin, ICAM, vWF, MDA, 15-F2t isoprostane)<br><br>All outcomes will be measured at baseline and at 8 weeks.

Secondary Outcome Measures

Name	Time	Method
Current secondary outcome measures as of 28/04/2014:<br>1. Anthropometric measures of height, weight and waist circumference, measured using methods outlined in the Manual of Dietetic Practice<br>2. Blood pressure<br><br>All outcomes will be measured at baseline and at 8 weeks; in addition the secondary outcomes will be measured at 4-week interim.<br><br>Previous secondary outcome measures:<br>Anthropometric measures of height, weight and waist circumference, measured using methods outlined in the Manual of Dietetic Practice.<br><br>All outcomes will be measured at baseline and at 8 weeks; in addition the secondary outcomes will be measured at 4-week interim.