High Protein Diets, Weight Loss and Diabetes Study 2007

Phase 4

Recruiting

• Conditions: Type 2 Diabetes; Obesity; Metabolic and Endocrine - Diabetes; Diet and Nutrition - Obesity

• Registration Number: ACTRN12606000475549
• Lead Sponsor: Commonwealth Scientific Research and Industraial Organisation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-11-15
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Body Mass Index (BMI) 25-40kg/m2 (this will be calculated for you)• Previously diagnosed Type 2 diabetes as noted on medical questionnaire or as assessed by a fasting blood glucose at screening (>6.1mmol/L).• HbA1C<9% (measured at screening)• Participants must understand the procedures involved and agree to participate in the study by giving full informed, written consent.• No abnormality of clinical significance on medical history (i.e. life-threatening cancer, liver or metabolic disease or cardiovascular problems - unstable angina, previous incidence of myocardial infarction, stroke or heart irregularity).• Not have type 1 diabetes (self reported)• Be available for the duration of the study (12 weeks).

Exclusion Criteria

Consumption of any over-the-counter medication or food (and unwilling to cease) that in the opinion of the investigator could interfere with the study (eg Policosanol, Metamucil, plant sterol margarines, psyllium).• The following items if taken need to be kept stable during the study: corticosteroids, diuretics, B-blockers, fish oil supplements, cholesterol lowering agents• History of heavy alcohol consumption (> 5 STD drinks/day)• Allergy to eggs• Type 2 diabetes controlled with insulin• Extended absences due to travel or other commitments• Person considered by the investigator to be unwilling, unlikely or unable to comprehend or comply with the study protocol and restrictions.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL) Total Cholesterol and triglycerides [At week 0 and week 12];2. Fasting ApoB [At week 0 and week 12];3. Glucose tolerance test (GTT) (0, 2hours) [At week 0 and week 12];4. Post prandial glucose using CGMS (36hr) [At week 0 and week 12];5. HbA1C[At week 0 and week 12]

Secondary Outcome Measures

Name	Time	Method
1. Plasma folate, homocysteine [at week 0 and 12];2. Cognitive function [at week 0 and 12];3. Satiety profiles [assessed over a 12 hour period at week 0 and 12];4. Weight loss (including lean and fat loss as assessed by bioelectrical impedance) [at week 0 and 12];5. Renal function (urinary urea, plasma creatinine and microalbuminuria) [at week 0 and 12];6. Plasma lutein zeaxanthein and other carotenoids [at week 0 and 12];7. Nutrient intakes before and during weight loss [at week 0 and 12]