|- candidate number||14053|
|- NTR Number||NTR3734|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||4-dec-2012|
|- Secondary IDs||Dia.6.C/A Danone Research|
|- Public Title||Effect of a diabetes-specific oral nutritional supplement (ONS) vs. standard ONS on the postprandial glucose response in adults with type 2 diabetes with (risk of) malnutrition.|
|- Scientific Title||Effect of a diabetes-specific oral nutritional supplement (ONS) vs. standard ONS on the postprandial glucose response in adults with type 2 diabetes with (risk of) malnutrition.|
|- hypothesis||Diabetes specific oral nutritional supplement has an improved 4-hour postprandial glucose response compared to standard oral nutritional supplement.|
|- Healt Condition(s) or Problem(s) studied||Diabetes Mellitus Type 2 (DM type II)|
|- 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||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 <8 g/dl or 5 mmol/L).
3. (Metabolic) disorders interfering with stable glucose metabolism (i.e. uncontrolled thyroid and/or adrenal disease, or interfering malignant diseases);
4. Concurrent condition /treatment that interferes with stable glucose metabolism (i.e. immediately post-operative);
5. Major infections (requiring antibiotics) within 3 weeks prior to study entry;
6. Concomitant therapy with systemic glucocorticoids within 2 weeks prior to study entry;
7. Pregnant female;
8. Requirement of a fibre-free diet;
9. Intolerance or allergy to dairy or other ingredients of the study products;
10. Alcohol intake of > 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.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||5-dec-2012|
|- planned closingdate||30-jun-2012|
|- Target number of participants||20|
|- 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.
|- Primary outcome||4-hour postprandial blood glucose response after consumption of diabetes-specific or standard ONS (iAUC0-4h).|
|- Secondary outcome||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.
|- Timepoints||Screening, Baseline, Day 1, Day 2, Day 3, Follow up.|
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||MSc. Marjolein Vossers|
|- CONTACT for SCIENTIFIC QUERIES|| Mirian Lansink|
|- Sponsor/Initiator ||Nutricia Research – Centre for Specialised Nutrition|
(Source(s) of Monetary or Material Support)
|Nutricia Research - Centre for Specialised Nutrition |
|- Brief summary||In this study the effect of a diabetes-specific oral nutritional supplement (ONS) on the 4-hour postprandial glucose response will be compared to a standard ONS in adults with type 2 diabetes with (risk of) malnutrition.|
|- Main changes (audit trail)|
|- RECORD||4-dec-2012 - 13-jan-2014|