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Trial record 38 of 94 for:    body | Recruiting, Not yet recruiting, Available Studies | "Metabolic Syndrome X"

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

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ClinicalTrials.gov Identifier: NCT03805802
Recruitment Status : Recruiting
First Posted : January 16, 2019
Last Update Posted : January 29, 2019
Sponsor:
Collaborator:
Glucanova AB
Information provided by (Responsible Party):
Dr. Per Humpert, Stoffwechselzentrum Rhein - Pfalz

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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Obesity Overweight Metabolic Syndrome Other: active product Other: reference product Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Quadruple (Participant, Care Provider, 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".
Primary Purpose: Treatment
Official Title: Influence of a Liquid Oat Bran Product on Blood Glucose in Patients With Poorly Controlled Type 2 Diabetes
Estimated Study Start Date : January 2019
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar

Arm Intervention/treatment
Experimental: active product
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
Once daily consumption over the period of the study
Other Names:
  • LOB
  • Liquid Oat Bran
  • High fiber product

Placebo Comparator: reference product
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
Once daily consumption over the period of the study
Other Names:
  • LOB
  • Liquid Oat Bran
  • High fiber product

Other: reference product
Once daily consumption over the period of the study
Other Name: placebo food product




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03805802


Contacts
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Contact: Per M Humpert, M. D. 06214909670 studien@stoffwechselzentrum-rhein-pfalz.de
Contact: Azat Samigullin, M. D. 06214909670 studien@stoffwechselzentrum-rhein-pfalz.de

Locations
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Germany
Stoffwechselzentrum Rhein-Pfalz Recruiting
Mannheim, Baden-Württemberg, Germany, 68163
Contact: Per M Humpert, M. D.    06214909670    studien@stoffwechselzentrum-rhein-pfalz.de   
Contact: Azat Samigullin, M. D.    06214909670    studien@stoffwechselzentrum-rhein-pfalz.de   
Sponsors and Collaborators
Stoffwechselzentrum Rhein - Pfalz
Glucanova AB
Investigators
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Principal Investigator: Per M Humpert, M. D. Director of Stoffwechselzentrum Rhein-Pfalz

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Responsible Party: Dr. Per Humpert, Director of Stoffwechselzentrum Rhein - Pfalz, Stoffwechselzentrum Rhein - Pfalz
ClinicalTrials.gov Identifier: NCT03805802     History of Changes
Other Study ID Numbers: 012019
First Posted: January 16, 2019    Key Record Dates
Last Update Posted: January 29, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dr. Per Humpert, Stoffwechselzentrum Rhein - Pfalz:
fiber
type 2 diabetes
dietary intervention
weight loss
glucose control
obesity
overweight
metabolic syndrome
oats

Additional relevant MeSH terms:
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Metabolic Syndrome
Body Weight
Diabetes Mellitus
Diabetes Mellitus, Type 2
Overweight
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Signs and Symptoms
Insulin Resistance
Hyperinsulinism