Diabetes Mellitus type 2
Conditions
Interventions
Duration of intervention: 3 days.
Intervention group: A high-energy, high-protein diabetes-specific ONS.
Control group: An isocaloric high-energy, high-protein ONS.
Sponsors
Danone Research - Centre for Specialised Nutrition
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age ≥ 18 yrs; 2. (At risk of) malnourishment, based on the presence of one or more of the following criteria: A. ≥ 5% involuntary weight loss in the last month, or; B. ≥ 10% involuntary weight loss in the last 6 months, or; C. Serum albumin < 35 g/L, or; D. Age ≥ 70 yrs and body mass index (BMI) < 21.0 kg/m2, or; D. Age < 70 yrs and BMI < 18.5 kg/m2, or; E. Age ≥ 65 yrs and Short Mini Nutritional Assessment (MNA) score ≤ 11. 3. Diagnosis of type 2 diabetes for at least six months; 4. On stable (20%) anti-hyperglycaemic therapy (oral medication and/or insulin) for at least 1 month prior to study entry; 5. Willingness and ability to comply with the study protocol, including: An overnight fast (at least 10 hours) at each study day. 6. Written informed consent.
Exclusion criteria
Exclusion criteria: 1. Any gastrointestinal disease that interferes with bowel function and nutritional intake (i.e. diabetes related diarrhoea secondary to neuropathy, diarrhoea due to chronic inflammatory bowel disease, gastroparesis); 2. Any known severe disease, i.e.: A. Heart failure (New York Heart Association (NYHA) class IV); B. Kidney disease (Chronic Kidney Disease (CKD) ≥ stage 4); C. Hepatic disease (transaminases > 5 times upper limit of normal); D. Severe anemia (hemoglobin 21 units per week for men and > 14 units per week for women; 11. Swallowing disorders making consumption of an oral nutritional supplement impossible; 12. Parenteral feeding / tube feeding; 13. Investigators' uncertainty about the willingness or ability of the subject to comply with the protocol requirements; 14. Participation in any other studies involving investigational or marketed products concomitantly or within 4 weeks prior to entry into the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 4-hour postprandial blood glucose response after consumption of diabetes-specific or standard ONS (iAUC0-4h). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. 4-hour postprandial responses after consumption of diabetes-specific or standard ONS: A. Blood glucose levels (iAUC0-4h) (serving size); B. Blood insulin levels (iAUC0-4h); C. Blood glucagon levels (iAUC0-4h). 2. Postprandial peak blood glucose, insulin and glucagon levels; 3. Postprandial delta peak blood glucose, insulin and glucagon levels. | — |
Contacts
Public ContactMarjolein Vossers
Danone Research - Centre for Specialised Nutrition P.O.Box 7005
Outcome results
None listed