Impact of carbohydrate and its sources on BMI, visceral fat and non-alcoholic fatty liver in patients with type 2 diabetes
Not Applicable
Recruiting
- Conditions
- type 2 diabetes
- Registration Number
- JPRN-UMIN000038314
- Lead Sponsor
- Haimoto Clinic
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 300
Inclusion Criteria
Not provided
Exclusion Criteria
Taking any type of oral hypoglycemic agent, insulin or steroid hormone from 3 months before baseline that would impact HbA1c levels; following strict carbohydrate restriction at baseline based on commercial diet therapies such as the Atkins diet; serum creatinine levels greater than 2.0 mg/dl, ketoacidosis, soft drink ketosis, cancer or decompensatory liver cirrhosis and alcoholic fatty liver disease.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method BMI and visceral fat by CT and CT value in the liver and spleen, macronutrients and carbohydrate sources based on dietary records at baseline and 6 months, and the association of changes in carbohydrate sources with changes in the above parameters.
- Secondary Outcome Measures
Name Time Method Insulin, HOMA-IR and serum lipid profile at baseline and 6 months later