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Completed

NCT Number: NCT03805802

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

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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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

active product

Other

Once daily consumption over the period of the study

Other names: LOB, Liquid Oat Bran, High fiber product

Reference product

Other

Once daily consumption over the period of the study

Other names: placebo food product

Primary outcomes

  1. Fasting glucose

    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.

Secondary outcomes

  1. Fasting glucose

    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.

  2. HBA1c

    Time frame: 6 weeks

    long-term glucose control as measured by the concentratino of HbA1c concentration in %

  3. HBA1c

    Time frame: 12 weeks

    long-term glucose control as measured by the concentratino of HbA1c concentration in %

  4. Self-documented glucose

    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

  5. Self-documented glucose

    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

  6. Weight

    Time frame: 6 weeks

    Chenge in body Weight in kg

  7. Weight

    Time frame: 12 weeks

    Chenge in body Weight in kg

  8. BMI

    Time frame: 6 weeks

    Body Mass Index

  9. BMI

    Time frame: 12 weeks

    Body Mass Index

  10. Lipid metabolism: Serum triglycerides

    Time frame: 6 weeks

    Markers of lipid metabolism at 6 weeks: triglycerides (mg/dl)

  11. Lipid metabolism: Serum triglycerides

    Time frame: 12 weeks

    Markers of lipid metabolism at 12 weeks: triglycerides (mg/dl)

  12. Lipid metabolism: apolipoprotein A (mg/dl)

    Time frame: 6 weeks

    Markers of lipid metabolism at 6 weeks: apolipoprotein A (mg/dl)

  13. Lipid metabolism: apolipoprotein A (mg/dl)

    Time frame: 12 weeks

    Markers of lipid metabolism at 12 weeks: apolipoprotein A (mg/dl)

  14. Lipid metabolism: Apolipoprotein B mg/dl

    Time frame: 6 weeks

    Markers of lipid metabolism at 6 weeks: Apolipoprotein B mg/dl

  15. Lipid metabolism: Apolipoprotein B mg/dl

    Time frame: 12 weeks

    Markers of lipid metabolism at 12 weeks: Apolipoprotein B mg/dl

  16. Lipid metabolism: Apolipoprotein B / Apolipoprotein A ratio

    Time frame: 6 weeks

    Metabolism at 6 weeks: Apolipoprotein B mg/dl / Apolipoprotein A mg/dl ratio

  17. Lipid metabolism: Apolipoprotein B / Apolipoprotein A ratio

    Time frame: 12 weeks

    Markers of lipid metabolism at 12 weeks: Apolipoprotein B mg/dl / Apolipoprotein A mg/dl ratio

  18. Lipid metabolism: HDL-cholesterol

    Time frame: 6 weeks

    Markers of lipid metabolism at 6 weeks: HDL-cholesterol mg/dl

  19. Lipid metabolism: HDL-cholesterol

    Time frame: 12 weeks

    Markers of lipid metabolism at 12 weeks: HDL-cholesterol mg/dl

  20. Lipid metabolism: LDL- cholesterol mg/dl

    Time frame: 6 weeks

    Markers of lipid metabolism at 6 weeks: LDL- cholesterol mg/dl

  21. Lipid metabolism: LDL- cholesterol mg/dl

    Time frame: 12 weeks

    Markers of lipid metabolism at 12 weeks: LDL- cholesterol mg/dl

  22. Microbiome

    Time frame: 6 weeks

    Microbiome in faeces samples at 6 weeks

  23. Microbiome

    Time frame: 12 weeks

    Microbiome in faeces samples at 12 weeks

  24. Inflammation: Il-6

    Time frame: 6 weeks

    Markers of inflammation at 6 weeks IL-6 in ng/ml

  25. Inflammation: hsCRP

    Time frame: 6 weeks

    Markers of inflammation at 6 weeks hsCRP mg/l

  26. Inflammation: Il-6

    Time frame: 12 weeks

    Markers of inflammation at 12 weeks IL-6 in ng/ml

  27. Inflammation: hsCRP

    Time frame: 12 weeks

    Markers of inflammation at 12 weeks hsCRP mg/l

Other outcomes

  1. Systolic lood pressure

    Time frame: 6 weeks

    Systolic blood pressure left arm 6 weeks in mm/Hg

  2. Diastolic blood pressure

    Time frame: 6 weeks

    Diastolic blood pressure left arm 6 weeks in mm/Hg

  3. Systolic blood pressure

    Time frame: 12 weeks

    Systolic blood pressure left arm 12 weeks in mm/Hg

  4. Diastolic blood pressure

    Time frame: 12 weeks

    Diastolic blood pressure left arm 12 weeks in mm/Hg

  5. Waist circumference

    Time frame: 6 weeks

    Waist circumference at 6 weeks in cm

  6. Waist circumference

    Time frame: 12 weeks

    Waist circumference at 12 weeks in cm

Sponsors and collaborators

Lead sponsor

Stoffwechselzentrum Rhein - Pfalz

Other

Collaborators

  • Glucanova AB

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jan 16, 2019
Registry last updated
Oct 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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