Effect of a new disease-specific enteral formula on metabolic control in type 2 diabetic patients.
Recruiting
- Conditions
- Diabetes Mellitus type 2 (DM type II)
- Registration Number
- NL-OMON21914
- Lead Sponsor
- umico Research B.V.
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 140
Inclusion Criteria
1. Type 2 diabetic patients
2. Diagnosis of type 2 diabetes according to WHO criteria for more than 6 months
Exclusion Criteria
1. Any gastrointestinal disease that interferes with bowel function and nutritional intake (i.e. diabetes related constipation/diarrhea secondary to neuropathy, diarrhea due to chronic inflammatory bowel disease, gastroparesis, gastrectomy)
2. Concomitant intake of parenteral nutrition or other clinical enteral nutrition
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method HbA1c
- Secondary Outcome Measures
Name Time Method 1. Fasting plasma glucose<br /><br>2. Fasting plasma insulin<br /><br>3. Fructosamine<br /><br>4. Fasting plasma lipid profile:<br /><br>Triglycerides, Total cholesterol, LDL, HDL<br /><br>5. Fasting free fatty acids (FFA)<br /><br>6. Total daily insulin requirement <br /><br>7. Insulin sensitivity by HOMA-IR<br /><br>8. Incidence of skin, pulmonary and urinary tract infections <br /><br>9. Fasting (hs) CRP<br /><br>10. Fasting pro-inflammatory cytokines: IL-6, IL-8, IL-18, and TNF-¨¢<br /><br>11. Fasting plasminogen activator inhibitor-1 activity (PAI-1)<br /><br>12. Blood pressure<br /><br>13. Tolerance<br /><br>