Influence of a Liquid Oat Bran Product on Blood Glucose in Patients With Poorly Controlled Type 2 Diabetes

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Influence of a Liquid Oat Bran Product on Blood Glucose in Patients With Poorly Controlled Type 2 Diabetes

Conditions
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Obesity, Diabetes Mellitus, Type 2, Overweight, Metabolic Syndrome

Intervention / Treatment
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* Other: active product
* Other: reference product


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 2 Diabetes with inadequate glucose control and a HbA1c >7,5 and < 9% Treatment with all oral antidiabetic medication or injectable GLP-1 analogues BMI 28,0-39,9 kg/m² Age 30-70 years Exclusion Criteria: insulin treatment Psychiatric Disease Acute Infections Alcohol or drug abuse Acute diverticulitis Malignant tumors or hematologic disorders Heart failure NYHA III-IV Acute coronary syndrome Chronic kidney disease > Stage 3 (KDOQI) Pregnancy or Lactation Previous bariatric interventions

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: active product<br>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). | Other: active product<br>* Once daily consumption over the period of the study<br>* Other names: High fiber product;|
| Placebo Comparator: reference product<br>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). | Other: active product<br>* Once daily consumption over the period of the study<br>* Other names: High fiber product;Other: reference product<br>* Once daily consumption over the period of the study<br>* Other names: placebo food product;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fiber, type 2 diabetes, dietary intervention, weight loss, glucose control, obesity, overweight, metabolic syndrome, oats