Diabetes Mellitus, Type 2, Metabolic Syndrome
Conditions
Keywords
Isomaltulose, Palatinose, second meal effect, incretin, GIP, GLP-1, postprandial inflammation
Brief summary
This study evaluates the different postprandial effect of isomaltulose and sucrose on the incretin profile and as an determinant for the second meal effect. In this nutritional intervention study, healthy participants and T2DM patients ingest 2 standardized meals for breakfast and lunch in combination with either sucrose or palatinose on 2 separate days. In addition, blood samples are taken to analyze markers of the carbohydrate metabolism, incretins and specific inflammation markers.
Detailed description
Isomaltulose is a natural occurring disaccharide with a similar structure to sucrose. It is composed of glucose and fructose, but is linked by an α-1,6-glycosidic bond instead of α-1,2. Due to its binding, isomaltulose is slowly hydrolysed, which results in a rather weak postprandial glycemic-insulinemic response, accompanied by a minimal GIP secretion and a stimulated secretion of GLP-1. In addition, several studies have shown that the intake of foods with a low glycemic index, such as isomaltulose, tend to improve the metabolic reaction to a subsequent meal. As the exact mechanism of this second meal effect is still unknown, the investigators hypothesize that the modified release and action of GIP and GLP-1 are key players in regard to the described effects.Therefore, isomaltulose could be a suitable tool for reducing the risk of developing diabetes, obesity and CVD as well as improve blood glucose control in people with diabetes. In summary, this study evaluates the different postprandial effect of isomaltulose and sucrose on the incretin profile and as a determinant for the second meal effect. In this nutritional intervention study, healthy participants and T2DM patients ingest 2 standardized meals for breakfast and lunch in combination with either sucrose or palatinose on 2 separated days. In addition, blood samples are taken to analyze markers of the carbohydrate metabolism, incretins and specific inflammation markers.
Interventions
DIETARY_SUPPLEMENTIntervention A
DIETARY_SUPPLEMENTIntervention B
DIETARY_SUPPLEMENTIntervention C
DIETARY_SUPPLEMENTIntervention D
Sponsors
Beneo GmbH
German Institute of Human Nutrition
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Masking description
participants were unaware of selected sugar intake prior to second meal
Intervention model description
Comparison of sucrose vs. palatinose (isomaltulose) on second meal effect (high-GI meal vs. high-protein meal) in subjects with T2DM or metabolic Syndrome without T2DM
Eligibility
Sex/Gender
ALL
Age
45 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* for T2DM patients: insulin-independent * for healthy subjects: at least 1 component of the metabolic syndrom: * Body mass index (BMI) ≥ 30 kg/m² * Waist-hip ratio (WHR) ≥ 85 for women and ≥ 90 for men * hypertension * dyslipidemia * glucose / insulin intolerance
Exclusion criteria
* medications: intake of medications which influence glucose metabolism * alcohol / drug abuse * physical diseases: endocrinological, malign, serious cardiovascular diseases * acute / chronic communicable disease * psychic diseases
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| disposition index | 4 visits, separated by 1 week each | Alteration of the Insulin secretion due to the intake of isomaltulose or sucrose in combination with different times and meal compositions. This should lead to an improved beta-cell response (Insulin secretion) |
| insulinogenic index | 4 visits, separated by 1 week each | Alteration of the incretin profile due to the intake of isomaltulose or sucrose in combination with different times and meal compositions. This should lead to an improved second meal effect (Insulin sensitivity). |
| hepatic insulin extraction | 4 visits, separated by 1 week each | Alteration of the incretin profile due to the intake of isomaltulose or sucrose in combination with different times and meal compositions. This should lead to an improved hepatic insulin extraction (secondary effect of improved Insulin sensitivity). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| incretin response | 4 visits, separated by 1 week each | Parameters: GIP, GLP-1, gastric emptying, Glucagon |
| additional endocrine parameters | 4 visits, separated by 1 week each | Parameters: FGF21 |
| inflammatory reaction | 4 visits, separated by 1 week each | Parameters: IL8, IL-18 |
| Lipid status | 4 visits, separated by 1 week each | Parameters: NEFA |
Countries
Germany
Outcome results
None listed