Associations of changes in HbA1c, insulin sensitivity, abdominal fat and plasma fatty acid composition with changes in macronutrients, carbohdyrate sources and alcohol intake under a 6-month moderate low-carbohydrate diet in type 2 diabetes
Not Applicable
- Conditions
- Type 2 diabetes
- Registration Number
- JPRN-UMIN000009866
- Lead Sponsor
- Haimoto Clinic
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 240
Inclusion Criteria
Not provided
Exclusion Criteria
Patients with serum creatinine levels > 2.0 mg/dl, ketoacidosis, soft drink ketosis, severe heart failure, severe liver cirrhosis, cancer, insulin therapy and implementing a low-carbohydrate diet at baseline.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method BMI, Hemoglobin A1c levels, plasma fatty composition, insulin sensitivity estimated by 75g-glucose tolerance test, abdominal fat measured by CT, macronutrients, carbohydrate sources, the type of protein, fat and alcohol by 3-day dietary records at baseline and after 6 months.
- Secondary Outcome Measures
Name Time Method Blood pressure, serum lipid profiles, blood chemical examinations, CT values of liver and spleen, micronutrients and salt equivalents estimated by 3-day dietary records, doses of anti-diabetic drugs, lipid lowering drugs and anti-hypertensive drugs at baseline and after 6 months.