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ID
Source
Brief title
Health condition
type 2 diabetes mellitus
Sponsors and support
Intervention
Outcome measures
Primary outcome
Postprandial blood glucose responses to a Meal Tolerance Test.
Secondary outcome
The effect of the study product on satiety.
Background summary
The purpose of this study is to assess
the effect of the study product (a protein and fibre-rich drink) on postprandial glycaemic responses, satiety, ¦Â-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.
Study objective
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.
Study design
Two 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.
Intervention
Intake 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.
Danone Research - Centre for Specialised Nutrition
Bosrandweg 20
Wageningen 6700 CA
The Netherlands
+31 (0)317 467 800
wessel.degraaf@danone.com
Danone Research - Centre for Specialised Nutrition
Bosrandweg 20
Wageningen 6700 CA
The Netherlands
+31 (0)317 467 800
wessel.degraaf@danone.com
Inclusion criteria
1. 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 criteria
1. 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 µmol/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.
Design
Recruitment
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| NTR-new | NL1582 |
| NTR-old | NTR1662 |
| Other | METC VUmc : 09/012 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |