Diabetes Mellitus, Type 2, Obesity, Overweight, Metabolic Syndrome
Conditions
Keywords
fiber, type 2 diabetes, dietary intervention, weight loss, glucose control, obesity, overweight, metabolic syndrome, oats
Brief summary
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
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.
Interventions
OTHERactive product
Once daily consumption over the period of the study
OTHERreference product
Once daily consumption over the period of the study
Sponsors
Glucanova AB
Stoffwechselzentrum Rhein - Pfalz
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
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.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
30 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fasting glucose | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lipid metabolism: Serum triglycerides | 6 weeks | Markers of lipid metabolism at 6 weeks: triglycerides (mg/dl) |
| Lipid metabolism: LDL- cholesterol mg/dl | 6 weeks | Markers of lipid metabolism at 6 weeks: LDL- cholesterol mg/dl |
| Microbiome | 6 weeks | Microbiome in faeces samples at 6 weeks |
| Inflammation: Il-6 | 6 weeks | Markers of inflammation at 6 weeks IL-6 in ng/ml |
| Inflammation: hsCRP | 6 weeks | Markers of inflammation at 6 weeks hsCRP mg/l |
| HBA1c | 6 weeks | long-term glucose control as measured by the concentratino of HbA1c concentration in % |
| Fasting glucose | 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. |
| Self-documented glucose | 6 weeks | Self-monitored glucose levels extracted from glucometers as a mean of the previous two weeks before study visits in mg/dl |
| Weight | 6 weeks | Chenge in body Weight in kg |
| BMI | 6 weeks | Body Mass Index |
| Lipid metabolism: apolipoprotein A (mg/dl) | 6 weeks | Markers of lipid metabolism at 6 weeks: apolipoprotein A (mg/dl) |
| Lipid metabolism: Apolipoprotein B mg/dl | 6 weeks | Markers of lipid metabolism at 6 weeks: Apolipoprotein B mg/dl |
| Lipid metabolism: Apolipoprotein B / Apolipoprotein A ratio | 6 weeks | Metabolism at 6 weeks: Apolipoprotein B mg/dl / Apolipoprotein A mg/dl ratio |
| Lipid metabolism: HDL-cholesterol | 6 weeks | Markers of lipid metabolism at 6 weeks: HDL-cholesterol mg/dl |
Other
| Measure | Time frame | Description |
|---|---|---|
| Systolic blood pressure | 12 weeks | Systolic blood pressure left arm 12 weeks in mm/Hg |
| Waist circumference | 6 weeks | Waist circumference at 6 weeks in cm |
| Diastolic blood pressure | 6 weeks | Diastolic blood pressure left arm 6 weeks in mm/Hg |
| Systolic lood pressure | 6 weeks | Systolic blood pressure left arm 6 weeks in mm/Hg |
Countries
Germany
Outcome results
None listed