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The effect of a protein/fibre drink on postprandial glycaemic metabolism in type 2 Diabetes Mellitus.


- candidate number5279
- NTR NumberNTR1662
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR6-feb-2009
- Secondary IDs09/012 METC VUmc
- Public TitleThe effect of a protein/fibre drink on postprandial glycaemic metabolism in type 2 Diabetes Mellitus.
- Scientific TitleThe effect of a protein/fibre drink on postprandial glycaemic metabolism in type 2 Diabetes Mellitus.
- ACRONYMGRACE: glucose reduction after caloric exposure
- hypothesisIt is expected that the drink will contribute to an improved postprandial glycaemic response and to an increase of satiety in subjects with type 2 diabetes mellitus.
- Healt Condition(s) or Problem(s) studiedDiabetes Mellitus Type 2 (DM type II)
- Inclusion criteria1. Written informed consent;
2. Age > 45 years;
3. Women: postmenopausal;
4. 25 < BMI > 35 kg/m2;
5. Type 2 diabetes mellitus with an HbA1C > 6.0 and < 8, preferably >6.4 and < 8, stable for the past 3 months as judged by the investigator;
6. No antidiabetic medication (i.e. sulphonylureas, insulin treatment) with the exemption of a stable and controlled anti-diabetic regime with metformin for at least 2 months and maximally 2000 mg/day and expected to remain stable throughout the duration of the study;
7. Willing to comply with the study protocol.
- Exclusion criteria1. On a weight loss diet;
2. Any gastrointestinal disease that interferes with bowel function and nutritional intake (i.e. diabetes related constipation or diarrhoea secondary to neuropathy, diarrhoea due to chronic inflammatory bowel disease, gastroparesis, (partial) gastrectomy or any other procedure for stomach volume reduction, including gastric banding);
3. Significant heart (NYHA class IV), pulmonary, hepatic (transaminase greater than 3 times normal), renal disease (requiring dialysis or creatinine >150 Ámol/l) or metabolic disorders;
4. Uncontrolled thyroid and/or adrenal disease, interfering malignant or haematological diseases;
5. Blood pressure > 160/90 mmHg , severe dyslipidemia (cholesterol > 8 mmol/l, triglycerides > 4 mmol/l);
6. Major infections (requiring antibiotics) within 3 weeks prior to study entry;
7. Concomitant therapy with sulfonylurea derivatives, acarbose, meglitinides, DPP-IV inhibitors, thiazolidinediones or insulin;
8. The use of drugs: all drugs that affect insulin secretion or insulin sensitivity, drugs or supplements that affect stomach pH, intestinal absorption and intestinal motility, moreover all concomitant medication should be discussed, in particular antiviral, oestrogens, progestagens, androgens, thiazide diuretics and anti-psychotic drugs;
9. Concomitant therapy with systemic glucocorticoids within 2 weeks prior to study entry;
10. Requirement of a fibre-free diet;
11. Alcohol intake of more than 21 alcohol containing drinks per week for men and 14 for women and the use of other drugs (e.g. marihuana and other soft drugs);
12. Investigator's uncertainty about the willingness or ability of the patient to comply with the protocol;
13. Participation in other clinical trials within 4 weeks of study entry.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 28-apr-2009
- planned closingdate15-nov-2009
- Target number of participants36
- InterventionsIntake of study product.
Duration of intervention: Approximately one month; one week on first study product followed by a 2-3 week wash out period and one week on the second studyproduct.
Intervention group: Type 2 Diabetes patients.
All included subjects will be treated with both the placebo and active product, in random order (cross-over study). Both study periods have a duration of 8 days in which the subjects consume 2 tetra packs of study product per day. There is a wash out period of 2 to 3 weeks in between the studyperiods. A study visit will take place at the first and last day of each studyperiod. During these visits blood will be drawn for examination of glucose responses. Each visit will take approx. 4.5 hours.
- Primary outcomePostprandial blood glucose responses to a Meal Tolerance Test.
- Secondary outcomeThe effect of the study product on satiety.
- TimepointsTwo study periods (cross-over) from day 1 - 8 with 2-3 week wash out in between. On day 1 and 8 study visits will take place to measure postprandial glycaemic response and satiety. During the study periods, study product will be used bi-daily.
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIES W. Graaf, de
- CONTACT for SCIENTIFIC QUERIES Mirian Lansink
- Sponsor/Initiator Danone Research B.V.
- Funding
(Source(s) of Monetary or Material Support)
Danone Research B.V.
- PublicationsN/A
- Brief summaryThe purpose of this study is to assess the effect of the study product (a protein and fibre-rich drink) on postprandial glycaemic responses, satiety, Ž┬-cell function and insulin sensitivity in type 2 diabetes mellitus. It is expected that the drink will contribute to an improved postprandial glycaemic response and to an increase of satiety in subjects with type 2 diabetes mellitus.
- Main changes (audit trail)Start date: kan geupdate worden naar 28 APR 2009 (was 15-02-09).
Closing date: is nu naar verwachting 15 NOV 2009 (was 15-09-09).
- RECORD6-feb-2009 - 5-apr-2010


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