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

Completed

• Conditions: Diabetes Mellitus type II (DM type II); Nutritional, Metabolic, Endocrine; Diabetes

• Registration Number: ISRCTN86065299
• Lead Sponsor: umico Research B.V. (The Netherlands)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-06-07
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 34

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified