ISRCTN86065299
Completed
Not Applicable
The effect of a disease-specific supplement on the postprandial plasma glucose response in type 2 diabetic patients at baseline and after 6 and 12 weeks of supplementatio
umico Research B.V. (The Netherlands)0 sites34 target enrollmentJune 7, 2006
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Diabetes Mellitus type II (DM type II)
- Sponsor
- umico Research B.V. (The Netherlands)
- Enrollment
- 34
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Diagnosis type 2 diabetes
- •2\. Age \>18
- •3\. HbA1c between 6\.5% \- 8\.5%
- •4\. Anti\-diabetic therapy: metformin and/or sulfonylureas
- •5\. In need of nutritional support
- •6\. Capable of using oral drink feed supplementation
- •7\. On a stable and controlled anti\-diabetic regime for at least one month
- •8\. Signed informed consent
Exclusion Criteria
- •1\. Pregnant or lactating woman or woman planning to become pregnant
- •2\. Usage of a disease\-specific nutritional supplement within past four weeks
- •5\. Concomitant therapy with systemic glucocorticoids, insulin or anti\-diabetic medication other than metformin or sulfonylureas
- •6\. Any acute gastrointestinal disease within two weeks prior to study entry
- •7\. Gastrectomy, gastroparesis or other gastric emptying abnormalities
- •8\. Acute severe heart failure, end stage liver failure or renal failure requiring dialysis
- •9\. Patients receiving enteral nutrition
- •10\. Patients with galactosaemia, fructosaemia or patients requiring a fibre\-free diet
- •11\. Drug or alcohol abuse
- •12\. Participation in other trials within 4 weeks of study entry
Outcomes
Primary Outcomes
Not specified
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