ESPRIT study
Completed
- Conditions
- type 2 diabetestype 2 diabetes patientsplasma glucose profile tube feeddisease-specificDM II
- Registration Number
- NL-OMON26603
- Lead Sponsor
- Danone Research ¨C Centre for Specialised Nutrition
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 24
Inclusion Criteria
Age/sex: males (age >= 18 yrs) or post-menopausal females
-Ambulant type 2 diabetes patients
Exclusion Criteria
-Any gastrointestinal disease that interferes with bowel function and nutritional intake (i.e. diabetes related constipation or diarrhea secondary to neuropathy, diarrhea due to chronic inflammatory bowel disease, gastroparesis, gastrectomy)
-Known heart failure, defined by New York Heart Association (NYHA) class IV
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Plasma glucose as assessed with the increase from baseline in plasma glucose levels in the t=3-4 hours period<br />
- Secondary Outcome Measures
Name Time Method - Glucose profile as assessed with:<br /><br>oiAUC mean glucose <br /><br>o(delta) peak glucose<br /><br>odifference between max-min glucose value<br /><br>odecline in glucose levels after stop tube feeding<br /><br>oincidence of hyperglycaemia (>10 mmol/L) <br /><br>oincidence of hypoglycaemia (<3.9 mmol/L)<br /><br>oAUC above cut-off lines of 10 mmol/L<br /><br>oAUC beneath cut-off lines of 3.9 mmol/L<br /><br>- Insulin<br />