Status:
COMPLETED
Influence of a Liquid Oat Bran Product on Blood Glucose in Patients With Poorly Controlled Type 2 Diabetes
Lead Sponsor:
Stoffwechselzentrum Rhein - Pfalz
Collaborating Sponsors:
Glucanova AB
Conditions:
Diabetes Mellitus, Type 2
Obesity
Eligibility:
All Genders
30-70 years
Phase:
NA
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 ...
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 fl...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 4 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2020
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT03805802
Start Date
February 4 2019
End Date
April 1 2020
Last Update
October 22 2020
Active Locations (1)
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1
Stoffwechselzentrum Rhein-Pfalz
Mannheim, Baden-Wurttemberg, Germany, 68163