Stoffwechselzentrum Rhein-Pfalz
Mannheim, Baden-Wurttemberg, 68163, Germany
NCT Number: NCT03805802
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.
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Notify Me30 year–70 year
All sexes
Interventional
Not applicable
Mannheim, Baden-Wurttemberg, 68163, Germany
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Once daily consumption over the period of the study
Other names: LOB, Liquid Oat Bran, High fiber product
Once daily consumption over the period of the study
Other names: placebo food product
Time frame: 6 weeks
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.
Time frame: 12 weeks
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.
Time frame: 6 weeks
long-term glucose control as measured by the concentratino of HbA1c concentration in %
Time frame: 12 weeks
long-term glucose control as measured by the concentratino of HbA1c concentration in %
Time frame: 6 weeks
Self-monitored glucose levels extracted from glucometers as a mean of the previous two weeks before study visits in mg/dl
Time frame: 12 weeks
Self-monitored glucose levels extracted from glucometers as a mean of the previous two weeks before study visits in mg/dl
Time frame: 6 weeks
Chenge in body Weight in kg
Time frame: 12 weeks
Chenge in body Weight in kg
Time frame: 6 weeks
Body Mass Index
Time frame: 12 weeks
Body Mass Index
Time frame: 6 weeks
Markers of lipid metabolism at 6 weeks: triglycerides (mg/dl)
Time frame: 12 weeks
Markers of lipid metabolism at 12 weeks: triglycerides (mg/dl)
Time frame: 6 weeks
Markers of lipid metabolism at 6 weeks: apolipoprotein A (mg/dl)
Time frame: 12 weeks
Markers of lipid metabolism at 12 weeks: apolipoprotein A (mg/dl)
Time frame: 6 weeks
Markers of lipid metabolism at 6 weeks: Apolipoprotein B mg/dl
Time frame: 12 weeks
Markers of lipid metabolism at 12 weeks: Apolipoprotein B mg/dl
Time frame: 6 weeks
Metabolism at 6 weeks: Apolipoprotein B mg/dl / Apolipoprotein A mg/dl ratio
Time frame: 12 weeks
Markers of lipid metabolism at 12 weeks: Apolipoprotein B mg/dl / Apolipoprotein A mg/dl ratio
Time frame: 6 weeks
Markers of lipid metabolism at 6 weeks: HDL-cholesterol mg/dl
Time frame: 12 weeks
Markers of lipid metabolism at 12 weeks: HDL-cholesterol mg/dl
Time frame: 6 weeks
Markers of lipid metabolism at 6 weeks: LDL- cholesterol mg/dl
Time frame: 12 weeks
Markers of lipid metabolism at 12 weeks: LDL- cholesterol mg/dl
Time frame: 6 weeks
Microbiome in faeces samples at 6 weeks
Time frame: 12 weeks
Microbiome in faeces samples at 12 weeks
Time frame: 6 weeks
Markers of inflammation at 6 weeks IL-6 in ng/ml
Time frame: 6 weeks
Markers of inflammation at 6 weeks hsCRP mg/l
Time frame: 12 weeks
Markers of inflammation at 12 weeks IL-6 in ng/ml
Time frame: 12 weeks
Markers of inflammation at 12 weeks hsCRP mg/l
Time frame: 6 weeks
Systolic blood pressure left arm 6 weeks in mm/Hg
Time frame: 6 weeks
Diastolic blood pressure left arm 6 weeks in mm/Hg
Time frame: 12 weeks
Systolic blood pressure left arm 12 weeks in mm/Hg
Time frame: 12 weeks
Diastolic blood pressure left arm 12 weeks in mm/Hg
Time frame: 6 weeks
Waist circumference at 6 weeks in cm
Time frame: 12 weeks
Waist circumference at 12 weeks in cm
Stoffwechselzentrum Rhein - Pfalz
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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