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| Name | Class |
|---|---|
| Glucanova AB | UNKNOWN |
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This study evaluates the effects of an ad libitum addition of a high fiber product to the regular diet of type 2 diabetes patients on body weight and blood sugar control. In the first 6 weeks half of the participants will receive the high fiber test product and half a reference product without fiber. After the first 6 weeks both groups will be switched to the high fiber product.
It has previously been shown that an increase in the consumption of fiber improves glucose control in type 2 diabetes. In addition, previous pilot studies have shown that a diet solely based on oat flakes can improve insulin sensitivity and glucose control in poorly controlled type 2 diabetes. Recent clinical data indicates, that early hyperglycemia can be normalized by a diet high in fiber. In this controlled pilot study, a food containing liquid oat bran high in fiber will be studied in type 2 diabetes patients with inadequate glucose control that are treated with oral medication or with additional once-daily insulin only against a reference product. 30 patients will be treated with the oat bran product or reference product over a period of 6 weeks in a double blinded approach, hereafter all participants will be switched to the oat bran product. The primary endpoint will be fasting glucose after 6 weeks. Secondary endpoints will be long-term glucose control as measured by HbA1c, self-documented glucose as well as the body weight and body mass index.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| active product | Experimental | Once daily ad libitum consumption of one package of the fiber product 6 weeks (blinded phase). Once daily ad libitum consumption of one package of the fiber product 6 weeks (open phase). |
|
| reference product | Placebo Comparator | Once daily ad libitum consumption of one package of placebo during 6 weeks (blinded phase). Once daily ad libitum consumption of one package of the fiber product 6 weeks (open phase). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| active product | Other | Once daily consumption over the period of the study |
|
| Measure | Description | Time Frame |
|---|---|---|
| Fasting glucose | Change in the concentratino of fasting venous glucose of daily LOB consumption in mg/dl as compared to the change in fasting glucose for the placebo group at 6 weeks. | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Fasting glucose | Change in the concentratino of fasting venous glucose of daily LOB consumption in mg/dl as compared to the change in fasting glucose for the placebo group at 12 weeks. | 12 weeks |
| HBA1c |
| Measure | Description | Time Frame |
|---|---|---|
| Systolic lood pressure | Systolic blood pressure left arm 6 weeks in mm/Hg | 6 weeks |
| Diastolic blood pressure | Diastolic blood pressure left arm 6 weeks in mm/Hg |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Per M Humpert, M. D. | Director of Stoffwechselzentrum Rhein-Pfalz | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stoffwechselzentrum Rhein-Pfalz | Mannheim | Baden-Wurttemberg | 68163 | Germany |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D009765 | Obesity |
| D050177 | Overweight |
| D024821 | Metabolic Syndrome |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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First 6 weeks double blinded vs. a reference product and second 6 weeks open label both groups receive the test product in the second 6 weeks.
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The investigator receives reference product and the test product in boxes labelled "stratus" "nimbus" and "cumulus". first 6 weeks participants are randomly assigned to "stratus" or "nimbus" and the second 6 weeks participants all receive "cumulus".
| reference product | Other | Once daily consumption over the period of the study |
|
|
long-term glucose control as measured by the concentratino of HbA1c concentration in %
| 6 weeks |
| HBA1c | long-term glucose control as measured by the concentratino of HbA1c concentration in % | 12 weeks |
| Self-documented glucose | Self-monitored glucose levels extracted from glucometers as a mean of the previous two weeks before study visits in mg/dl | 6 weeks |
| Self-documented glucose | Self-monitored glucose levels extracted from glucometers as a mean of the previous two weeks before study visits in mg/dl | 12 weeks |
| Weight | Chenge in body Weight in kg | 6 weeks |
| Weight | Chenge in body Weight in kg | 12 weeks |
| BMI | Body Mass Index | 6 weeks |
| BMI | Body Mass Index | 12 weeks |
| Lipid metabolism: Serum triglycerides | Markers of lipid metabolism at 6 weeks: triglycerides (mg/dl) | 6 weeks |
| Lipid metabolism: Serum triglycerides | Markers of lipid metabolism at 12 weeks: triglycerides (mg/dl) | 12 weeks |
| Lipid metabolism: apolipoprotein A (mg/dl) | Markers of lipid metabolism at 6 weeks: apolipoprotein A (mg/dl) | 6 weeks |
| Lipid metabolism: apolipoprotein A (mg/dl) | Markers of lipid metabolism at 12 weeks: apolipoprotein A (mg/dl) | 12 weeks |
| Lipid metabolism: Apolipoprotein B mg/dl | Markers of lipid metabolism at 6 weeks: Apolipoprotein B mg/dl | 6 weeks |
| Lipid metabolism: Apolipoprotein B mg/dl | Markers of lipid metabolism at 12 weeks: Apolipoprotein B mg/dl | 12 weeks |
| Lipid metabolism: Apolipoprotein B / Apolipoprotein A ratio | Metabolism at 6 weeks: Apolipoprotein B mg/dl / Apolipoprotein A mg/dl ratio | 6 weeks |
| Lipid metabolism: Apolipoprotein B / Apolipoprotein A ratio | Markers of lipid metabolism at 12 weeks: Apolipoprotein B mg/dl / Apolipoprotein A mg/dl ratio | 12 weeks |
| Lipid metabolism: HDL-cholesterol | Markers of lipid metabolism at 6 weeks: HDL-cholesterol mg/dl | 6 weeks |
| Lipid metabolism: HDL-cholesterol | Markers of lipid metabolism at 12 weeks: HDL-cholesterol mg/dl | 12 weeks |
| Lipid metabolism: LDL- cholesterol mg/dl | Markers of lipid metabolism at 6 weeks: LDL- cholesterol mg/dl | 6 weeks |
| Lipid metabolism: LDL- cholesterol mg/dl | Markers of lipid metabolism at 12 weeks: LDL- cholesterol mg/dl | 12 weeks |
| Microbiome | Microbiome in faeces samples at 6 weeks | 6 weeks |
| Microbiome | Microbiome in faeces samples at 12 weeks | 12 weeks |
| Inflammation: Il-6 | Markers of inflammation at 6 weeks IL-6 in ng/ml | 6 weeks |
| Inflammation: hsCRP | Markers of inflammation at 6 weeks hsCRP mg/l | 6 weeks |
| Inflammation: Il-6 | Markers of inflammation at 12 weeks IL-6 in ng/ml | 12 weeks |
| Inflammation: hsCRP | Markers of inflammation at 12 weeks hsCRP mg/l | 12 weeks |
| 6 weeks |
| Systolic blood pressure | Systolic blood pressure left arm 12 weeks in mm/Hg | 12 weeks |
| Diastolic blood pressure | Diastolic blood pressure left arm 12 weeks in mm/Hg | 12 weeks |
| Waist circumference | Waist circumference at 6 weeks in cm | 6 weeks |
| Waist circumference | Waist circumference at 12 weeks in cm | 12 weeks |
| D004700 | Endocrine System Diseases |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D001836 | Body Weight Changes |